Category: Local News

Categories
Business Culture Government Local News Politics Programs & Events

The AACCNJ announces Hon. Tahesha Way, Esq., NJ Lt.-Gov., Secretary of State to make opening remarks at 2024 Black History Month, Black-Tie Gala

TRENTON, N.J. — The African American Chamber of Commerce of New Jersey (AACCNJ) announces that the Honorable Tahesha Way, Esq., NJ Lieutenant Governor and  Secretary of State, will make opening remarks at the 14th Annual Circle of Achievement Awards Gala on Feb. 22 at the Venetian in Garfield, N.J.

 

“We are excited to have the Lieutenant Governor join us for our Black History Month Gala,” said John E. Harmon, Sr., IOM, Founder, President & CEO, AACCNJ.

 

“We are at a critical juncture for our co-existence in NJ. The Lieutenant Governor’s presence is significant and appreciated as we look forward to advancing a more intentional economic agenda to improve the social economic standing of Black people in NJ. This will be a night of Excellence on full display.”

 

The AACCNJ 2024 Annual Awards Gala themed “Leading the Way” is the premier Black History Month event in the state of NJ. Each year at the black-tie affair, the AACCNJ recognizes a distinguished group of African Americans that have attained a significant level of accomplishment in business, politics, education, sports and/or entertainment. The event provides the platform, on behalf of the members of the AACCNJ and the over 88,000 Black owned businesses in the state of NJ, to continue to increase the visibility of its members and their businesses.

 

2024 Honorees:

The Honorable Benjamin Crump, Founder & Principal, Ben Crump Law; will be presented with the Presidential Award of Excellence. Brett J. Hart, President, United Airlines, and Dr. Darcella Patterson Sessomes, Chief, Division of Programs and Reintegration Services, State of New Jersey, Department of Corrections will both receive the Community Service Award. Keith D. Wright, PhD., Director, Business Diversity Operations, Office of Diversity, Equity & Inclusion, Port Authority of NY&NJ will receive the Public Service Award.

 

The evening will begin with a “Black Carpet Experience” for the attendees, honorees and guests and will also include a Cocktail Reception in the Grand Ballroom and dinner, dancing, and the Awards Ceremony in the Palazzo Ballroom.

 

The 2024 Gala “Exclusive” Sponsor is Truist. Gala Gold Sponsors include Atlantic Health Center, Consolidated Edison, Horizon Blue Cross Blue Shield of NJ, Milhouse Engineering, PSEG, Provident Bank, United Airlines, Valley National Bank. Silver Sponsors include American Water, Atlantic City Electric, Atlantic Shore Winds, Citizen’s Bank, Davis EIS, JCP&L, Lakeland Bank, NJ Economic Development Authority (NJEDA), PNC and SJI.

 

More information can be found at www.aaccnj.com  https://www.aaccnj.com/gala

 

About the African American Chamber of Commerce of New Jersey

The AACCNJ performs an essential role in the economic viability of New Jersey. While providing a platform for New Jersey’s African American business leaders, to speak with a collective voice, the AACCNJ advocates and promotes economic diversity fostering a climate of business growth through major initiatives centering on education and public policy. The Chamber serves as a proactive advocacy group with a 501(c) 3 tax exemption, which is shared by the National Black Chamber of Commerce.

Categories
Business Culture Economics Lifestyle Local News Regulations & Security Science

Church & Dwight reports fourth quarter and full year 2023 results

2023 Fourth Quarter Results

  • Net Sales growth +6.4%: Domestic +6.4%, Int’l +11.9%, SPD -9.2 %
  • Organic sales +5.3%: Domestic +5.7%, Int’l +9.0%, SPD -9.2%1
  • Gross Margin +260 bps
  • Reported EPS $0.62, Adjusted EPS $0.65, +4.8%1

2023 Full Year Results

  • Net Sales growth +9.2%; Organic Sales +5.3%1
  • Gross Margin +220 bps
  • Reported EPS $3.05, Adjusted EPS $3.17, +6.7%1
  • Cash from operations $1.03 billion

 

 

EWING, N.J. — (BUSINESS WIRE) — Church & Dwight Co., Inc. (NYSE: CHD) today announced full year net sales increased 9.2% to $5,867.9 million, ahead of the Company’s outlook of 9%. Organic sales increased 5.3% due to positive pricing of 4.4% and higher volume of 0.9%.1 Organic sales of consumer products increased 6.2%.

 

Full year EPS was $3.05, an increase of 81.5% compared to 2022 reported EPS. Full year 2023 Adjusted EPS was $3.17, an increase of 6.7% compared to 2022 Adjusted EPS.1 Full year Adjusted EPS exceeded the Company’s outlook of $3.15, driven by higher sales, higher gross margin and a lower tax rate, partially offset by higher SG&A.

 

Q4 net sales were $1,528.0 million, a $92.0 million or 6.4% increase compared to net sales in Q4 2022. This exceeded the Company’s outlook of 5% growth. Organic sales increased 5.3%1, exceeding the Company’s outlook of 4%, driven by 4.0% positive price and product mix and 1.3% higher volume. Reported EPS for Q4 was $0.62. Adjusted EPS in Q4 was $0.65 compared to $0.62 Adjusted EPS in Q4 2022.

 

Matthew Farrell, Chief Executive Officer, commented, “Our full year 2023 results illustrate the strength of our brands, innovative new products, and our focus on execution. We are exiting the year with strong momentum after posting two consecutive quarters of year-over-year volume growth. We expect volume to continue to drive growth into 2024. Our domestic brands grew consumption in 10 of 17 categories in 2023. We grew share on brands representing 60% of our sales. Global online sales accounted for 20% of total consumer sales in 2023, an increase of 26% compared to 2022.

 

“Our recent acquisitions, THERABREATH™ mouthwash and HERO™, the maker of MIGHTY PATCH™ acne care products, both experienced high consumption growth and grew market share throughout 2023. We expect these brands to deliver strong growth in 2024.

 

“Organic revenue growth for the Domestic Division grew 5.7% in 2023 driven by growth across much of the portfolio. Organic revenue growth for the International Division grew 8.5% in 2023, driven by broad-based growth in our country subsidiaries and our Global Markets Group. The International Division will continue to be a growth engine for the Company in 2024. Our Specialty Products Division declined 7.9% in 2023, largely due to declining sales of our MEGALAC dairy supplement within our Animal Nutrition business. We will be exiting this part of the Animal Nutrition business during Q1 2024.

 

“We were especially pleased by the strong gross margin expansion that we saw in 2023 with productivity, pricing, volume, and strong contributions from higher margin acquisitions more than offsetting inflation.

 

“Finally, strong sales and margin expansion along with efficient working capital management were all key drivers of our strong cash flow generation in 2023, achieving over $1 billion in cash from operations for the first time.

 

Fourth Quarter Review

Consumer Domestic net sales were $1,193.0 million, a $72.2 million or 6.4% increase driven by both household and personal care sales growth. Organic sales increased 5.7% due to price and product mix (+4.2%) and volume (+1.5%). This is the second consecutive quarter of volume growth, despite the impact of ceasing sub-optimal laundry promotions. Growth was led by HERO acne treatments, THERABREATH mouthwash, ARM & HAMMER™ Cat Litter, ARM & HAMMER™ baking soda and ARM & HAMMER™ unit dose laundry detergent.

 

Consumer International net sales were $258.8 million, a $27.5 million or 11.9% increase. Foreign currency exchange rates impacted sales favorably by (+2.7%). Organic sales increased 9.0% due to a combination of higher price and product mix (+5.1%) and higher volume (+3.9%). This is the fourth consecutive quarter of volume growth. Q4 organic sales were primarily driven by STERIMAR™, THERABREATH, ARM & HAMMER baking soda and HERO.

 

Specialty Products net sales were $76.2 million, a $7.7 million or a 9.2% decrease. Organic sales decreased 9.2% primarily due to lower volume (9.0%) driven by the dairy business, particularly MEGALAC which continues to be impacted by low-priced imports.

 

Gross margin increased 260 basis points to 44.6% due to improved pricing, volume, productivity, and the impact of the HERO acquisition, partially offset by higher manufacturing costs.

 

Marketing expense was $219.0 million, which was $29.3 million higher than prior year. Marketing expense as a percentage of net sales increased 110 basis points to 14.3%.

 

Selling, general, and administrative expense (SG&A) was $246.2 million, including $7.3 million of charges related to restricted stock that was issued for the HERO acquisition. Adjusted SG&A was $238.9 million or 15.6% of net sales, a 210 basis points increase, primarily due to higher incentive compensation from improved business performance, investment spending for future growth and minor asset write-offs related to our Specialty Products division.

 

Income from Operations was $216.1 million. Adjusted Income from Operations was $223.4 million, an increase of 2.2% inclusive of higher marketing and SG&A.

 

Other Expense was $20.9 million, a decrease of $4.6 million primarily due to higher interest income.

 

The effective tax rate decreased to 21.3% compared to 26.4% in Q4 2022. On an adjusted basis the tax rate was 20.5% compared to a rate of 21.3% in Q4 2022. The reported tax rate of 26.4% in Q4 2022 was unusually high due to the impact of the FLAWLESS™ intangible asset impairment charge.

 

Operating Cash Flow

For the full year 2023, cash from operations was $1,030.6 million, an increase of $145.4 million due to higher cash earnings and improvements in working capital. Capital expenditures for the full year were $223.5 million, a $44.7 million increase from the prior year as we invested in capacity expansion projects.

 

At December 31, 2023, cash on hand was $344.5 million, while total debt was $2.4 billion.

 

4% Dividend Increase and Share Repurchase

Consistent with the Company’s capital allocation strategy, the Company’s Board of Directors declared a 4% increase in the quarterly dividend from $0.2725 to $0.28375 per share, equivalent to an annual dividend of $1.135 per share. This raises the annual dividend payout from $267 million to approximately $276 million. The quarterly dividend will be payable March 1st, 2024, to stockholders of record at the close of business on February 15th, 2024. This is the 28th consecutive year in which the Company has increased the dividend. The Company has paid a consecutive quarterly dividend for 123 years.

 

In Q4, the Company spent $300 million to repurchase 3.3 million shares of common stock. Currently, the Company has approximately 246 million weighted average shares outstanding.

 

Mr. Farrell commented, “Our dividend increase and share repurchases reflect the Company’s desire for stockholders to benefit from our strong cash generation and reflects our confidence in continuing our strong performance. 2024 should be another year of strong cash flow. Our robust cash flow enables us to return cash to our stockholders while maintaining significant financial flexibility to aggressively pursue acquisitions and invest in our business.”

 

2024 New Products

Mr. Farrell commented, “Product innovation continues to be a big driver of our success and we are excited about our new product launches. In 2024, we expect new product launches to drive a significant increase in net sales as we lead with innovation in a number of key categories.”

 

ARM & HAMMER™ Laundry is launching Deep Clean™ Liquid and Deep Clean Unit Dose Laundry Detergent. Arm & Hammer Deep Clean will be our most premium Arm & Hammer laundry detergent, entering the mid-tier of the category using pH Power Technology to penetrate deep into fibers where dirt, odor, and stains linger, delivering a superior clean at a price consumers can afford.

 

ARM & HAMMER™ launched Power Sheets™ Laundry Detergent online in August 2023. This innovative laundry solution is effective, convenient, and eliminates plastic bottle waste. ARM & HAMMER™ is the first major brand to offer a detergent sheet in the U.S. and became the #2 detergent sheet on Amazon within 4 weeks of launch. It was the #1 top seller in the laundry category on Amazon Prime Day. Due to its online success, Power Sheets ™ will be available in select brick & mortar retailers in early 2024.

 

ARM & HAMMER™ Hardball™ Clumping Litter is being expanded nationally in early 2024, after successful in-market testing in 2023. This transformational plant-based substrate is lightweight and creates virtually indestructible clumps for no-mess scooping. We expect this new litter to help ARM & HAMMER capture a greater share of the lightweight litter category.

 

THERABREATH™, the #1 alcohol-free mouthwash brand, is entering the antiseptic segment of the category with the launch of TheraBreath™ Deep Clean Oral Rinse. Antiseptic mouthwashes account for 30% of the category. This product is formulated to kill 99.9% of germs that cause bad breath, plaque & gingivitis without the burn.

 

BATISTE™, the leader in dry shampoo, is meeting consumers’ desire for longer-lasting results with new BATISTE Sweat Activated and BATISTE Touch Activated dry shampoos. These breakthrough products are formulated with advanced technology and release a burst of fragrance whenever you sweat or touch your hair. Both new products deliver up to 24 hours of freshness.

 

HERO™ continues to drive the majority of growth in the acne category as the #1 patch brand in the U.S. In 2024, Hero will continue to launch innovative solutions in patches combined with new launches, such as Dissolve Away Daily Cleansing Balm, that will broaden our offerings of gentle and effective solutions for acne-prone skin.

 

Outlook for 2024

Mr. Farrell stated, “We exited 2023 with strong consumption growth across the majority of our categories. We are confident about 2024 and remain focused on offering high quality products to consumers at the right value.

 

“We are evolving our long-term Evergreen business model in 2024. The last revision was in 2018. Our new annual Evergreen model reflects our expectation of faster topline growth, greater margin expansion, and a higher cadence of growth investment, specifically in ecommerce and international. The revised evergreen model calls for 4% organic net sales growth (previously 3%), 25 to 50 basis points of gross margin expansion (previously 25 bps), marketing as a percentage of sales continues to approximate 11% (no change), and SG&A leverage of 0-25 bps (previously 25 bps) reflecting investments which will help sustain accelerated growth for years to come. We are maintaining our 8% industry leading annual EPS growth target.

 

“In 2024 we expect full year reported and organic sales growth to be approximately 4-5%.1 The organic sales outlook excludes Megalac from both years and the impact from foreign currency. We expect full year reported gross margin to expand approximately 50 to 75 basis points versus 2023. We expect an increase in manufacturing costs primarily due to capacity related investments, third party manufacturing cost increases, and moderate commodity inflation. We expect to more than offset our cost increases through carryover product pricing, mix, higher volume and productivity. We expect marketing as a percentage of sales to be approximately 11% and we expect to leverage SG&A while making investments in our International and ecommerce infrastructure.

 

“Our Adjusted EPS expectation for 2024 is 7-9% growth (mid-point $3.42 Adjusted EPS), inclusive of a 1% EPS drag related to exiting the MEGALAC business. Excluding the MEGALAC impact, Adjusted EPS growth expectation is 8-10%. Our tax rate is expected to increase 170 bps to approximately 23%. The higher tax rate represents a 2% drag to Adjusted EPS. This outlook reflects strong operating fundamentals including organic sales growth, volume growth, margin expansion and operating income growth.

 

“Other expense for 2024 is expected to be approximately $85 million, compared to $90 million in 2023.

 

“Cash flow from operations is expected to be approximately $1.0 billion. We expect 2024 capital expenditures of approximately $180 million as we complete the major capacity investments that were initiated in 2023. We expect capital spending to return to historical levels (2% of sales) in 2025. We will pursue accretive acquisitions that meet our strict criteria, with an emphasis on fast-moving consumable products, similar to our last 3 acquisitions (ZICAM, THERABREATH, and HERO).

 

“In past years, we have highlighted and discussed 14 power brands within our portfolio. In the future, we will focus our communication on seven brands that we expect to be the key drivers of growth. These brands, which today represent 70% of our sales and profits, primarily compete in larger categories and have the potential for global expansion. The seven brands are ARM & HAMMER™, OXICLEAN™, BATISTE™, VITAFUSION™, WATERPIK™, THERABREATH™ and HERO™.

 

“For Q1, we expect reported and organic sales growth of approximately 4%1, gross margin expansion and higher marketing spending (+100 basis points) to support our strong innovation pipeline. As a result of the shift in marketing spend to Q1, we expect Adjusted EPS of $0.85 per share, flat versus last year’s adjusted Q1 EPS.”1

 

1 Organic Sales, Adjusted SG&A, Adjusted Income from Operations, Adjusted Tax Rate and Adjusted EPS are non-GAAP measures. See Non-GAAP reconciliations included at the end of this release.

 

Church & Dwight Co., Inc. (NYSE: CHD) will host a webcast to discuss fourth quarter and year end 2023 results on Feb. 2, 2024, at 12:00 p.m. (ET). The presentation will broadcast online at investor.churchdwight.com/investors/news-events. Click on Church & Dwight Co., Inc. 2024 Analyst Day to register for the webcast.

 

Church & Dwight Co., Inc. (NYSE: CHD) founded in 1846, is the leading U.S. producer of sodium bicarbonate, popularly known as baking soda. The Company manufactures and markets a wide range of personal care, household, and specialty products under recognized brand names such as ARM & HAMMER®, TROJAN®, OXICLEAN®, SPINBRUSH®, FIRST RESPONSE®, NAIR®, ORAJEL®, XTRA®, L’IL CRITTERS® and VITAFUSION®, BATISTE®, WATERPIK®, ZICAM®, THERABREATH® and HERO®. For more information, visit the Company’s website.

 

Church & Dwight has a strong heritage of commitment to people and the planet. In the early 1900’s, we began using recycled paperboard for all packaging of household products. Today, virtually all our paperboard packaging is from certified, sustainable sources. In 1970, the ARM & HAMMER brand introduced the first nationally distributed, phosphate-free detergent. That same year, Church & Dwight was honored to be the sole corporate sponsor of the first annual Earth Day. In 2023, our continued progress earned continued public recognition, including the Newsweek Magazine’s Americas Most Responsible and America’s Greenest Companies lists, the EPA’s Green Power Partnership-Top 100 list, the 2023 Wall Street Journal Management Top 250 List, the 2022/2023 Forbes Magazine: Americas Best Midsize Employer Award and the FTSE4Good Index Series, amongst others.

 

For more information, see the Church & Dwight 2022 Sustainability Report at: https://churchdwight.com/responsibility/

This press release contains forward-looking statements, including, among others, statements relating to net sales and earnings growth; gross margin changes; trade, marketing, and SG&A spending; recessionary conditions; interest rates; inflation; sufficiency of cash flows from operations; earnings per share; cost savings programs; consumer demand and spending; the effects of competition; the effect of product mix; volume growth, including the effects of new product launches into new and existing categories; the impact of acquisitions (including earn-outs); and capital expenditures. Other forward-looking statements in this release may be identified by the use of such terms as “may,” “could,” “expect,” “intend,” “believe,” “plan,” “estimate,” “forecast,” “project,” “anticipate,” “to be,” “to make” or other comparable terms. These statements represent the intentions, plans, expectations and beliefs of the Company, and are based on assumptions that the Company believes are reasonable but may prove to be incorrect. In addition, these statements are subject to risks, uncertainties and other factors, many of which are outside the Company’s control and could cause actual results to differ materially from such forward-looking statements. Factors that could cause such differences include a decline in market growth, retailer distribution and consumer demand (as a result of, among other things, political, economic and marketplace conditions and events), including those relating to the outbreak of contagious diseases; other impacts of the COVID-19 pandemic and its impact on the Company’s operations, customers, suppliers, employees, and other constituents, and market volatility and impact on the economy (including contributions to recessionary conditions), resulting from global, nationwide or local or regional outbreaks or increases in infections, new variants, and the risk that the Company will not be able to successfully execute its response plans with respect to the pandemic or localized outbreaks and the corresponding uncertainty; the impact of new legislation such as the U.S. CARES Act, the EU Medical Device Regulation, new cosmetic and device regulations in Mexico, and the U.S. Modernization of Cosmetic Regulation Act; the impact on the global economy of the Russia/Ukraine war and increased conflict in the Middle East, including the impact of export controls and other economic sanctions; potential recessionary conditions or economic uncertainty; the impact of continued shifts in consumer behavior, including accelerating shifts to on-line shopping; unanticipated increases in raw material and energy prices, including as a result of the Russia/Ukraine war, increased conflict in the Middle East or other inflationary pressures; delays and increased costs in manufacturing and distribution; increases in transportation costs; labor shortages; the impact of price increases for our products; the impact of inflationary conditions; the impact of supply chain and labor disruptions; the impact of severe or inclement weather on raw material and transportation costs; adverse developments affecting the financial condition of major customers and suppliers; competition; changes in marketing and promotional spending; growth or declines in various product categories and the impact of customer actions in response to changes in consumer demand and the economy, including increasing shelf space or on-line share of private label and retailer-branded products or other changes in the retail environment; consumer and competitor reaction to, and customer acceptance of, new product introductions and features; the Company’s ability to maintain product quality and characteristics at a level acceptable to our customers and consumers; disruptions in the banking system and financial markets; the Company’s borrowing capacity and ability to finance its operations and potential acquisitions; higher interest rates; foreign currency exchange rate fluctuations; transition to, and shifting economic policies in the United States; potential changes in export/import and trade laws, regulations and policies of the United States and other countries, including any increased trade restrictions or tariffs; increased or changing regulation regarding the Company’s products and its suppliers in the United States and other countries where it or its suppliers operate; market volatility; issues relating to the Company’s information technology and controls; the impact of natural disasters, including those related to climate change, on the Company and its customers and suppliers, including third party information technology service providers; integrations of acquisitions or divestiture of assets; the outcome of contingencies, including litigation, pending regulatory proceedings and environmental matters; and changes in the regulatory environment in the countries where we do business.

 

For a description of additional factors that could cause actual results to differ materially from the forward-looking statements, please see Item 1A, “Risk Factors” in the Company’s annual report on Form 10-K and quarterly reports on Form 10-Q. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by the U.S. federal securities laws. You are advised, however, to consult any further disclosures the Company makes on related subjects in its filings with the United States Securities and Exchange Commission.

 

This press release also contains non-GAAP financial information. Management uses this information in its internal analysis of results and believes that this information may be informative to investors in gauging the quality of the Company’s financial performance, identifying trends in its results and providing meaningful period-to-period comparisons. The Company has included reconciliations of these non-GAAP financial measures to the most directly comparable financial measure calculated in accordance with GAAP. See the end of this press release for these reconciliations. These non-GAAP financial measures should not be considered in isolation or as a substitute for the comparable GAAP measures. In addition, these non-GAAP financial measures may not be the same as similar measures provided by other companies due to potential differences in methods of calculation and items being excluded. They should be read in connection with the Company’s financial statements presented in accordance with GAAP.

 

 

CHURCH & DWIGHT CO., INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Income (Unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

December 31,

December 31,

(In millions, except per share data)

2023

2022

2023

2022

Net Sales

$

1,528.0

$

1,436.0

$

5,867.9

$

5,375.6

Cost of sales

846.7

833.5

3,279.4

3,125.6

Gross Profit

681.3

602.5

2,588.5

2,250.0

Marketing expenses

219.0

189.7

641.3

535.2

Selling, general and administrative expenses

246.2

611.2

889.8

1,117.0

Income from Operations

216.1

(198.4

)

1,057.4

597.8

Equity in earnings of affiliates

0.6

2.3

8.7

12.3

Other income (expense), net

(21.5

)

(27.8

)

(98.7

)

(86.8

)

Income before Income Taxes

195.2

(223.9

)

967.4

523.3

Income taxes

41.5

(59.2

)

211.8

109.4

Net Income

$

153.7

$

(164.7

)

$

755.6

$

413.9

Net Income per share – Basic

$

0.63

$

(0.68

)

$

3.09

$

1.70

Net Income per share – Diluted

$

0.62

$

(0.67

)

$

3.05

$

1.68

Dividends per share

$

0.27

$

0.26

$

1.09

$

1.05

Weighted average shares outstanding – Basic

244.6

243.6

244.9

242.9

Weighted average shares outstanding – Diluted

247.0

246.1

247.6

246.3

CHURCH & DWIGHT CO., INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(Dollars in millions)

Dec. 31, 2023

Dec. 31, 2022

Assets

Current Assets

Cash and Cash Equivalents

$

344.5

$

270.3

Accounts Receivable

526.9

422.0

Inventories

613.3

646.6

Other Current Assets

45.0

57.0

Total Current Assets

1,529.7

1,395.9

Property, Plant and Equipment (Net)

927.7

761.1

Equity Investment in Affiliates

12.0

12.7

Trade Names and Other Intangibles

3,302.3

3,431.6

Goodwill

2,431.5

2,426.8

Other Long-Term Assets

366.0

317.5

Total Assets

$

8,569.2

$

8,345.6

Liabilities and Stockholders’ Equity

Short-Term Debt

$

3.9

$

74.0

Current portion of Long-Term debt

199.9

0.0

Other Current Liabilities

1,218.2

1,109.8

Total Current Liabilities

1,422.0

1,183.8

Long-Term Debt

2,202.2

2,599.5

Other Long-Term Liabilities

1,089.6

1,072.4

Stockholders’ Equity

3,855.4

3,489.9

Total Liabilities and Stockholders’ Equity

$

8,569.2

$

8,345.6

Contacts

Rick Dierker

Chief Financial Officer

609-806-1200

Read full story here

Categories
Business Economics Healthcare Lifestyle Local News Science

Bristol Myers Squibb reports fourth quarter and full-year financial results for 2023

Results Reflect Continued Strength of In-Line and New Products, Pipeline Execution and Business Development Activity, Supporting Growth Momentum into 2024

 

  • Reports Fourth Quarter Revenues of $11.5 Billion; GAAP EPS of $0.87 and Non-GAAP EPS of $1.70
    • In-Line and New Product Portfolio Revenues Increased 9% to $9.8 Billion
  • Reports Full-Year Revenues of $45.0 Billion; GAAP EPS of $3.86 and Non-GAAP EPS of $7.51
    • In-Line and New Product Portfolio Revenues Increased 7% to $37.9 Billion
  • Strengthens Long-Term Growth Profile Through Multiple Transactions, Including Planned Acquisitions of Karuna Therapeutics and RayzeBio and Strategic Collaboration with SystImmune; Completes Purchase of Mirati Therapeutics
  • Advances Research Pipeline Including U.S. Approval of Augtyro and FDA Acceptance of sBLAs for Breyanzi in Follicular Lymphoma and Mantle Cell Lymphoma for Priority Review
  • Provides 2024 Guidance with Revenues Increasing by Low Single-Digits; Non-GAAP EPS Range $7.10 to $7.40, Excludes Impact of Pending Transactions

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — Bristol Myers Squibb (NYSE: BMY) today reports results for the fourth quarter and full year of 2023, which reflect strong pipeline acceleration, continued portfolio diversification, and momentum in our business.

“We saw good performance in the fourth quarter from our in-line and new products and took several actions to strengthen the company and build a foundation for sustainable growth,” said Christopher Boerner, Ph.D., chief executive officer, Bristol Myers Squibb.

 

“In 2024, our focus is on delivering strong commercial execution and accelerating opportunities that enhance our growth profile in the middle of the decade and beyond.”

 

 

Fourth Quarter

Full Year

$ in millions, except per share amounts

2023

2022

Change

Change Excl.

F/X**

2023

2022

Change

Change Excl.

F/X**

Total Revenues

$11,477

$11,406

1%

1%

$45,006

$46,159

(2)%

(2)%

EPS — GAAP*

0.87

0.95

(8)%

N/A

3.86

2.95

31%

N/A

EPS — Non-GAAP*

1.70

1.82

(7)%

N/A

7.51

7.70

(2)%

N/A

Acquired IPRD charge and Licensing Income Net Impact (Decrease)/Increase

(0.20)

(0.01)

N/A

N/A

(0.28)

(0.24)

N/A

N/A

* GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income.

** See “Use of Non-GAAP Financial Information”.

 

 

FOURTH QUARTER RESULTS

All comparisons are made versus the same period in 2022 unless otherwise stated.

  • Bristol Myers Squibb posted fourth quarter revenues of $11.5 billion, an increase of 1% both on a reported and when adjusted for foreign exchange basis, primarily due to higher sales of new product portfolio, as well as Eliquis and Opdivo, partially offset by lower sales of Revlimid.
  • U.S. revenues increased 1% to $8.0 billion primarily due to higher sales of new product portfolio, Eliquis and Opdivo, partially offset by lower sales of Revlimid.
  • International revenues remained relatively flat at $3.5 billion, primarily due to lower sales of Revlimid, offset by higher sales ofnew product portfolio and Opdivo.
  • On a GAAP basis, gross margin decreased from 77.3% to 76.1% and on a non-GAAP basis, gross margin decreased from 77.9% to 76.4% primarily due to product mix and lower hedge settlement gains.
  • On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 9% to $2.1 billion primarily due to timing of spend.
  • On a GAAP and non-GAAP basis, research and development expenses remained relatively flat at $2.5 billion.
  • On a GAAP and non-GAAP basis, Acquired IPRD increased to $600 million from $52 million primarily due to the reacquired mavacamten rights of $445 million in China and certain other Asian territories. On a GAAP and non-GAAP basis, licensing income was $67 million compared to $16 million during the same period a year ago.
  • On a GAAP basis, amortization of acquired intangible assets decreased 3% to $2.3 billion primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
  • On a GAAP basis, income tax benefit was $88 million despite pre-tax earnings of $1.7 billion primarily due to a valuation allowance reversal related to unrealized equity investment losses and foreign currency. In 2022, the income tax benefit was $166 million despite pre-tax earnings of $1.9 billion primarily due to the release of income tax reserves. On a non-GAAP basis, the effective tax rate changed from 10.9% to 14.9%, primarily due to release of income tax reserves in 2022.
  • The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $1.8 billion, or $0.87 per share, compared to $2.0 billion, or $0.95 per share, for the same period a year ago. In addition to the items above, the decrease in GAAP EPS was driven by lower losses in equity investments. The company reported on a non-GAAP basis net earnings attributable to Bristol Myers Squibb of $3.5 billion, or $1.70 per share, compared to $3.9 billion, or $1.82 per share, for the same period a year ago. The EPS results in the fourth quarter of 2023 also include the impact of lower weighted-average common shares outstanding.

 

 

FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS

($ amounts in millions)

Quarter Ended December

31, 2023

% Change from Quarter

Ended December 31,

2022

% Change from

Quarter Ended

December 31,

2022 Ex-F/X**

U.S.(c)

Int’l

WW(d)

U.S.(c)

Int’l

WW(d)

Int’l

WW(d)

In-Line Products

Eliquis

$

1,899

$

975

$

2,874

11%

1%

7%

(3)%

6%

Opdivo

1,411

976

2,387

12%

3%

8%

4%

8%

Orencia

766

219

985

8%

8%

8%

11%

9%

Pomalyst/Imnovid

632

258

890

1%

2%

1%

—%

1%

Yervoy

343

223

566

(1)%

—%

— %

1%

—%

Sprycel

417

109

526

—%

(32)%

(9)%

(31)%

(9)%

Mature and other products (a)

202

278

480

9%

(6)%

—%

(5)%

1%

Total In-Line Products

5,670

3,038

8,708

8%

(1) %

5 %

(1)%

5%

New Product Portfolio

Reblozyl

274

46

320

75%

10%

61%

5%

60%

Opdualag

187

3

190

80%

N/A

83%

N/A

83%

Abecma

56

44

100

(40)%

42%

(20)%

39%

(21)%

Zeposia

101

32

133

74%

52%

68%

43%

66%

Breyanzi

85

16

101

*

23%

84%

23%

84%

Camzyos

84

4

88

*

N/A

*

N/A

*

Sotyktu

56

7

63

*

N/A

*

N/A

*

Onureg

31

16

47

15%

60%

27%

50%

24%

Inrebic

19

10

29

12%

67%

26%

67%

26%

Augtyro

1

—

1

N/A

N/A

N/A

N/A

N/A

Total New Product Portfolio

894

178

1,072

71%

45%

66%

39%

65%

Total In-Line and New Product Portfolio

6,564

3,216

9,780

13%

1%

9%

1%

9%

Recent LOE Products (b)

Revlimid

1,262

188

1,450

(38)%

(21)%

(36)%

(20)%

(36)%

Abraxane

177

70

247

53%

11%

38%

22%

42%

Total Recent LOE Products

1,439

258

1,697

(33)%

(15)%

(30)%

(11)%

(30)%

Total Revenues

$

8,003

$

3,474

$

11,477

1%

—%

1%

—%

1%

*

In excess of +100%

**

See “Use of Non-GAAP Financial Information”.

(a)

Includes over-the-counter (OTC) products, royalty revenue and mature products.

(b)

Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.

(c)

Includes Puerto Rico.

(d)

Worldwide (WW) includes U.S. and International (Int’l).

 

 

FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS

In-Line Products

Revenues for in-line products in the fourth quarter were $8.7 billion compared to $8.3 billion in the prior year period. In-line products revenue was largely driven by:

  • Eliquis worldwide revenues increased 7%, or 6% when adjusted for foreign exchange impacts. U.S. revenues were $1.9 billion compared to $1.7 billion in the prior year period, representing an increase of 11% primarily due to higher demand, partially offset by GTN adjustments in 2023. International revenues were $975 million compared to $970 million in the prior year period, representing an increase of 1%, or a decrease of 3% when adjusted for foreign exchange impacts, primarily driven by lower average net selling prices and generic erosion in several European countries.
  • Opdivo worldwide revenues increased 8% both on a reported and when adjusted for foreign exchange basis. U.S. revenues increased 12% to $1.4 billion compared to $1.3 billion in the prior year period primarily due to higher demand. International revenues were $976 million compared to $951 million in the prior year period, representing an increase of 3%, or 4% when adjusted for foreign exchange impacts, primarily due to higher demand as a result of launches for new indications and core indications.

New Product Portfolio

  • New product portfolio worldwide revenues increased to $1.1 billion compared to $645 million in the prior year period, representing a growth of 66%, or 65% when adjusted for foreign exchange impacts, primarily driven by higher demand across the portfolio, including for Reblozyl, Opdualag, Camzyos, Sotyktu, Zeposia and Breyanzi.

Recent LOE Products

  • Revlimid worldwide revenues declined to $1.5 billion compared to $2.3 billion in the prior year period, representing a decline of 36%, both on a reported and when adjusted for foreign exchange basis, primarily due to generic erosion.

PRODUCT AND PIPELINE UPDATE

The company recently achieved several important regulatory and clinical milestones. In November 2023, Augtyro received U.S. regulatory approval in non-small cell lung cancer. The U.S. Food and Drug Administration (FDA) also accepted supplemental Biologics License Applications (sBLAs) for Breyanzi to expand into follicular lymphoma and mantle cell lymphoma.

Oncology

Category

Asset

Milestone

Regulatory

KRAZATI®

(adagrasib)

The European Commission (EC) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.

repotrectinib

The European Medicines Agency (EMA) validated the marketing authorization application for repotrectinib as a treatment for ROS1 tyrosine kinase inhibitor (TKI)-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic NSCLC and TKI naïve- and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on the registrational Phase 1/2 TRIDENT-1 trial and CARE study. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.

Opdivo®

(nivolumab)

The FDA accepted the sBLA for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.

In addition, the EMA validated the type II variation application for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.

The FDA’s sBLA acceptance and the EMA’s application validation are based on results from the Phase 3 CheckMate -901 trial.

AugtyroTM

(repotrectinib)

The FDA approved Augtyro, a TKI, for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval is based on results from the pivotal TRIDENT-1 study.

Clinical &

Research

Subcutaneous

nivolumab

Data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy, demonstrated noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous Opdivo. In addition, subcutaneous nivolumab displayed noninferior objective response rate as assessed by Blinded Independent Central Review (BICR) versus intravenous Opdivo.

Opdivo

Four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with CABOMETYX® (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) continued to show superior progression-free survival (PFS) and objective response rates in patients treated with Opdivo plus CABOMETYX over sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) scores. Superior overall survival (OS) was also observed in patients treated with the combination.

Opdivo+Yervoy

Eight-year data from the Phase 3 CheckMate -214 trial evaluating Opdivo plus Yervoy versus sunitinib continued to demonstrate long-term survival results, reducing the risk of death by 28% in patients with previously untreated advanced or metastatic RCC, regardless of IMDC risk group. Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.

The Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer (MSI-H/dMMR mCRC) met the dual primary endpoint of PFS as assessed by BICR at a pre-specified interim analysis. The study is ongoing to assess the other dual primary endpoint of PFS per BICR in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints, including overall survival.

In addition, data from the Phase 3 CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with MSI-H/dMMR mCRC compared to chemotherapy. Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy in MSI-H/dMMR mCRC.

OpdualagTM

(nivolumab and

relatlimab)

The Phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable metastatic colorectal cancer patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee. It was determined that the trial was unlikely to meet its primary endpoints upon completion. The recommendation to stop the study was not based on safety concerns.

Hematology

Category

Asset

Milestone

Regulatory

Abecma®

(idecabtagene

vicleucel)

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended marketing authorization approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union.

Reblozyl®

(luspatercept-

aamt)

Japan’s Ministry of Health, Labour and Welfare (MHLW) granted manufacturing and marketing approval for Reblozyl 25 mg/75 mg injection for subcutaneous use indicated for myelodysplastic syndrome (MDS)-related anemia. The approval is based on the results of the global Phase 3 COMMANDS trial and the Phase 3 MEDALIST study, as well as a Japanese Phase 2 study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients.

Breyanzi®

(lisocabtagene

maraleucel)

The FDA accepted sBLAs for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor. The FDA granted both applications Priority Review and assigned a PDUFA goal date of May 23, 2024, for Breyanzi in relapsed or refractory FL and May 31, 2024, for Breyanzi in relapsed or refractory MCL.

In addition, Japan’s MHLW has also accepted the company’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.

In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study. In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study.

Abecma

Japan’s MHLW granted manufacturing and marketing approval of the sNDA for an additional indication for Abecma for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The approval is based on the interim analysis from the KarMMa-3 trial.

Breyanzi

The FDA accepted the sBLA for Breyanzi to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor. The FDA granted the application Priority Review and assigned a PDUFA goal date of March 14, 2024.

Clinical &

Research

Abecma

Results from the preplanned final progression-free survival (PFS) analysis of the pivotal Phase 3, open-label, global, randomized controlled KarMMa-3 trial demonstrated a significantly improved PFS maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death.

Breyanzi

First disclosure of primary analysis results from the high-risk, second-line cohort of the Phase 2 TRANSCEND FL trial evaluating Breyanzi in patients with relapsed or refractory FL demonstrated 95.7% complete response for patients with high-risk relapsed or refractory FL treated in a second-line setting.

Reblozyl

Updated results from the primary analysis of the Phase 3 COMMANDS trial, comparing Reblozyl versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes who may require red blood cell transfusions, confirmed positive outcome of the interim analysis with superior efficacy and durability compared to ESAs.

 

 

FULL YEAR FINANCIAL RESULTS

All comparisons are made versus the same period in 2022 unless otherwise stated.

  • Bristol Myers Squibb posted revenues of $45.0 billion, a decrease of 2%, both on a reported and when adjusted for foreign exchange basis, primarily due to lower sales of Revlimid, partially offset by higher sales of our new product portfolio and Opdivo.
  • U.S. revenues decreased 1%to$31.6 billion due to lower sales of Revlimid resulting from generic erosion and, as previously disclosed, an increase in the number of patients receiving free drug product for Revlimid, and to a lesser extent Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products. This was partially offset by an increase in demand for Opdivo, Eliquis and new product portfolio.
  • International revenues decreased 6% to $13.5 billion, or 5% when adjusted for foreign exchange impacts, primarily due to lower sales of Revlimid and Eliquis, partially offset by an increase in demand for Opdivo and new product portfolio.
  • On a GAAP basis, gross margin decreased from 78.0% to 76.2% and on a non-GAAP basis, gross margin decreased from 78.8% to 76.6%, primarily due to product mix and lower hedge settlement gains.
  • On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 1% to $7.8 billion and $7.7 billion, respectively.
  • On a GAAP basis, research and development expenses decreased 2% to $9.3 billion. On a non-GAAP basis, research and development expenses decreased 1% to $9.1 billion.
  • On a GAAP and non-GAAP basis, Acquired IPRD increased 12% to $913 million. On a GAAP and non-GAAP basis, licensing income was $142 million during the year compared to $103 million in 2022.
  • On a GAAP basis, amortization of acquired intangible assets decreased 6% to $9.0 billion. The decrease was primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
  • On a GAAP basis, effective tax rate changed from 17.7% to 4.7% primarily due to the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment and changes in income tax reserves, valuation allowances and IRS guidance regarding deductibility of certain non-U.S. research and development expenses. On a non-GAAP basis, the effective tax rate changed from 15.3% to 14.7%.
  • The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $8.0 billion, or $3.86 per share, compared to $6.3 billion, or $2.95 per share. In addition to the items above, the GAAP EPS was impacted by lower losses on equity investments as well as litigation and other settlement income in 2023. On a non-GAAP basis, net earnings attributable to Bristol Myers Squibb were $15.6 billion, or $7.51 per share, compared to $16.5 billion, or $7.70 per share. In addition to the non-GAAP drivers noted above, the non-GAAP EPS was impacted by higher royalty and investment income, as well as lower weighted-average common shares outstanding.

 

 

FULL YEAR PRODUCT REVENUE HIGHLIGHTS

($ amounts in millions)

Year Ended December 31,

2023

% Change from Year

Ended December 31,

2022

% Change from

Year Ended

December 31,

2022 Ex-F/X**

U.S.(c)

Int’l

WW(d)

U.S.(c)

Int’l

WW(d)

Int’l

WW(d)

In-Line Products

Eliquis

$

8,592

$

3,614

$

12,206

10%

(10)%

4%

(10)%

3%

Opdivo

5,283

3,726

9,009

10%

8%

9%

11%

10%

Orencia

2,754

847

3,601

4%

3%

4%

6%

5%

Pomalyst/Imnovid

2,357

1,084

3,441

(3)%

2%

(2)%

3%

(1)%

Yervoy

1,388

850

2,238

6%

3%

5%

5%

6%

Sprycel

1,446

484

1,930

(3)%

(28)%

(11)%

(25)%

(10)%

Mature and other products (a)

772

1,123

1,895

3%

(13)%

(7)%

(11)%

(6)%

Total In-Line Products

22,592

11,728

34,320

6%

(3)%

3%

(2)%

4%

New Product Portfolio

Reblozyl

811

197

1,008

37%

56%

41%

54%

40%

Opdualag

617

10

627

*

N/A

*

N/A

*

Abecma

358

114

472

21%

25%

22%

24%

21%

Zeposia

324

110

434

83%

51%

74%

47%

72%

Breyanzi

303

61

364

*

97%

100%

*

*

Camzyos

226

5

231

*

N/A

*

N/A

*

Sotyktu

157

13

170

*

N/A

*

N/A

*

Onureg

117

51

168

23%

76%

35%

72%

35%

Inrebic

74

36

110

7%

*

29%

*

29%

Augtyro

1

—

1

N/A

N/A

N/A

N/A

N/A

Total New Product Portfolio

2,988

597

3,585

80%

63%

77%

61%

76%

Total In-Line and New Product Portfolio

25,580

12,325

37,905

12%

(1)%

7%

—%

8%

Recent LOE Products (b)

Revlimid

5,266

831

6,097

(37)%

(49)%

(39)%

(47)%

(39)%

Abraxane

709

295

1,004

22%

28%

24%

39%

27%

Total Recent LOE Products

5,975

1,126

7,101

(33)%

(39)%

(34)%

(36)%

(34)%

Total Revenues

$

31,555

$

13,451

$

45,006

(1)%

(6)%

(2)%

(5)%

(2)%

 

Contacts

For more information, contact:
Media: media@bms.com
Investor Relations: investor.relations@bms.com

Read full story here

Categories
Business Healthcare Lifestyle Local News Science

Subcutaneous nivolumab (nivolumab and hyaluronidase) shows noninferiority compared to intravenous Opdivo (nivolumab) in advanced or metastatic clear cell renal cell carcinoma in CheckMate -67T trial

CheckMate -67T is the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics, efficacy and safety vs. its intravenous formulation

Subcutaneous nivolumab demonstrated noninferior pharmacokinetics (co-primary endpoints) and objective response rate (key powered secondary endpoint) compared to intravenous Opdivo

Results from the Phase 3 CheckMate -67T trial will be presented in a late-breaking oral presentation at ASCO GU 2024 in the first ever disclosure for subcutaneous formulation of Opdivo

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO — Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy, demonstrating noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo.

 

In addition, subcutaneous nivolumab displayed noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo. These results will be featured in a late-breaking oral presentation (Abstract #LBA360) at the American Society of Clinical Oncology (ASCO) 2024 Genitourinary Cancers Symposium from January 25-27, 2024.

“The data from CheckMate -67T with the subcutaneous formulation of nivolumab co-formulated with recombinant human hyaluronidase represent a groundbreaking advancement in oncology research for physicians and our patients,” said Saby George, M.D., F.A.C.P., professor of Oncology and Medicine, director of Network Clinical Trials, Department of Medicine, Roswell Park Comprehensive Cancer Center.

 

“Having the option to administer immunotherapy subcutaneously could undoubtedly reduce the treatment burden that patients diagnosed with cancer currently face, as well as help maximize efficiencies within healthcare systems. As it stands, intravenous immunotherapy infusion can take precious time, which we know is an important commodity for patients and the doctors who treat them. That’s why these results indicating noninferiority with subcutaneous nivolumab have the potential to be practice-changing and to improve patients’ treatment experience with one injection that can be given in under five minutes and, in some cases, outside of the infusion center.”

 

In the CheckMate -67T trial investigating subcutaneous nivolumab (n=248) vs. IV Opdivo (n=247) in patients with advanced of metastatic ccRCC:

  • Cavgd28: Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the time-averaged serum concentration over the first 28 days, with a geometric mean ratio of 2.098 (90% Confidence Interval [CI]: 2.001 – 2.200).
  • Cminss: Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the minimum serum concentration at steady state, with a geometric mean ratio of 1.774 (90% CI: 1.633 – 1.927).
  • ORR: Noninferiority was also seen in the key powered secondary endpoint of ORR by BICR, with subcutaneous nivolumab demonstrating an ORR of 24.2% vs. 18.2% with IV Opdivo (Relative Risk Ratio [RR] 1.33; 95% CI: 0.94 to 1.87).
  • PFS: Median PFS by BICR with subcutaneous nivolumab was 7.23 months and 5.65 months with IV Opdivo.
  • Safety: The safety profile of subcutaneous nivolumab was consistent with the IV formulation. Incidence of local injection site reactions with subcutaneous nivolumab was 8.1%. Additionally, reactions were low grade and transient. Among patients treated with subcutaneous nivolumab (n=247), grade 3-4 adverse events (AEs) occurred in 35.2% of patients vs. 40.8% of patients treated with IV Opdivo (n=245). Treatment-related AEs occurred in 9.7% vs. 14.7% of patients, serious AEs in 21.1% vs. 22.9% of patients and treatment-related serious AEs in 6.5% of patients for both the subcutaneous and IV formulations.

 

“These results from the CheckMate -67T trial build on our deep scientific expertise in the use of immunotherapy in solid tumor oncology and our commitment to finding ways to help improve quality of life for patients,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb.

 

“We are thrilled to present this research for the first time evaluating subcutaneous nivolumab, demonstrating noninferiority compared to intravenous Opdivo and supporting subcutaneous nivolumab as a potential new option to improve healthcare efficiency. Convenience is an important benefit of subcutaneous immunotherapy and we are excited about the potential for this treatment to reduce patient burden and provide greater flexibility to patients and health care providers. We look forward to discussing next steps for subcutaneous nivolumab across multiple tumor types with health authorities.”

 

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -67T clinical trial.

 

About CheckMate -67T

CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.

 

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Clear cell renal carcinoma (ccRCC) is the most common form of RCC, affecting about 7 out of 10 people with RCC. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival (DFS) rates for those with localized disease that can be resected are just over 50%.

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.

 

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

 

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

 

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

 

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

 

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

 

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

 

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

 

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

 

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

 

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

 

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).

 

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).

 

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).

 

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

Read full story here

Categories
Business Culture Economics Education Government Lifestyle Local News

The AACCNJ plans to host a Town Hall Meeting to address  ‘The Fierce Urgency of Now’ — A Presentation on the State’s Disparity Study

TRENTON, N.J. —  “The African American Chamber of Commerce of New Jersey (AACCNJ) will host a town hall meeting topic: “The Fierce Urgency of Now” – A Presentation on the State’s newly released Disparity Study, conducted by Mason Tillman Associates, LTD.

 

The Town Hall Meeting will be held at The Crowne Plaza Princeton, N.J. on Feb. 6 from 3 to 5 p.m., and is a free event. The Presentation will be led by Dr. Denise Anderson, Founder & CEO, Denise Anderson & Associates (DA&A) LLC, moderated by John E. Harmon, Sr., IOM, Founder, President & CEO, AACCNJ, and will include a Q&A session with the audience.

 

“The Study, as expected, revealed that African American businesses received little of the $ 18.5 billion the Murphy administration spent on contracts for construction, professional services and goods and services from 2015 to 2020,” said John E. Harmon, Sr.

 

“While expecting the worst, little did we know that the Study would document African Americans received less than one (1) percent of the $18.5 billion dollars the State awarded to contractors. African American businesses received a pittance despite the fact that we represent, 14 percent of the population, and over 10 percent of the businesses in New Jersey willing and able to contract with the State.”

 

The Study also documented that all ethnic groups received fewer contracts than expected given the number of New Jersey businesses owned by people of color. More than 25 percent of the businesses the Study identified as willing and able to contract with the State were owned by African Americans, Asian Americans, Hispanic Americans, and Native Americans.

 

“Now that the State’s commissioned study has documented the institutional discrimination our members have long experienced, we must demand that the Murphy Administration immediately establish a race and gender-based program with minority and woman-owned business utilization goals to end the discriminatory practices in its award of contracts,” said Harmon.

 

“As we move forward, we ask the Governor and his administration to also hold a statewide meeting, to discuss the results of the disparity study,” said Harmon.

 

“We plan to work in partnership with the State to put forth best practices that will provide the constituency of the AACCNJ, and others, with consistent access to opportunities and resources that they can leverage to strengthen their enterprises and ideals while mitigating past underperformance,” said Harmon.

“Our mutual goal henceforth is to have a more equitable participation in every area of the public sector wherein economic opportunities exist.”

 

“These times remind me of words that were expressed by the late Dr. Martin Luther King, Jr.: “The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy,” said Harmon.

 

 

About the African American Chamber of Commerce of New Jersey

The AACCNJ performs an essential role in the economic viability of New Jersey. While providing a platform for New Jersey’s African American business leaders, to speak with a collective voice, the AACCNJ advocates and promotes economic diversity fostering a climate of business growth through major initiatives centering on education and public policy. The Chamber serves as a proactive advocacy group with a 501(c) 3 tax exemption, which is shared by the National Black Chamber of Commerce.

Categories
Business Culture Economics Government Lifestyle Local News Perspectives Politics Regulations & Security

The AACCNJ responds to the press announcement of the Murphy Administration’s Disparity Study

TRENTON, N.J. —  The African American Chamber of Commerce of New Jersey (AACCNJ) responds to the release of the Murphy Administration’s Disparity Study.

The Office of Diversity and Inclusion oversaw the effort, which was the first study of its kind to be commissioned by the State since 2003. It was conducted by Mason Tillman Associates, LTD.

Gov. Murphy recently signed a package of legislation into law in Trenton. (Rich Hundley III/ NJ Governors Office).

“On behalf of the 1.2 million black residents and over 88,000 black owned businesses in the state of New Jersey, the announcement of the completion of the disparity study, is the news that we have been patiently awaiting and have prepared our hearts and minds to receive,” said John E. Harmon, Sr., IOM., Founder, President & CEO, African American Chamber of Commerce of N.J. (AACCNJ).

“Acknowledgement is an essential step to establishing the proper pathway to a credible coexistence. Today’s announcement serves as confirmation of what we all knew, and we are eagerly looking forward to a focused strategic alignment with the Murphy Administration, said Harmon.”

“This study speaks to the intolerance for equitable participation in taxpayer funded opportunities resulting in wide social and economic disparities that cannot be glossed over. It is incumbent on this administration, and the legislature, to not try to appease Black and Brown People with well-crafted conciliatory statements given the magnitude of harm we have been dealt with over the years,” said John E. Harmon, Sr.

“As I read through the pages of the Disparity Study it is difficult for me to conclude that there was not a greater degree of awareness, which should have led our leaders to figure out how they could have procured more opportunities to make our state more equitable, while we awaited the completion of the Mason Tillman Study,” said Harmon.

“There were substantial gains for contract awardees and elected officials since 2015 and the economic benefits for Blacks and Brown people in our state have not been reciprocated. The Port Authority of New York and New Jersey completed its disparity study in 2017 with results that were almost identical. Herein, a lost opportunity to apply best practices to really produce a Stronger and Fairer Economy,” said Harmon.

“We just celebrated in the past week, what would have been the 95th birthday of Rev. Dr. Martin Luther King, Jr., his powerful words have even greater significance today,” said John E. Harmon, Sr.

“An individual has not started living fully until they can rise above the narrow confines of individualistic concerns to the broader concerns of humanity. Every person must decide, at some point, whether they will walk in the light of creative altruism, or in the darkness of destructive selfishness,” Dr. Martin Luther King Jr., Montgomery, AL. Aug. 11, 1957.

“As we move forward, we plan to work in partnership with the State to put forth best practices that will provide the constituency of the AACCNJ, and others, with consistent access to opportunities and resources that they can leverage to strengthen their enterprises and ideals while mitigating past underperformance,” said Harmon. “Our mutual goal henceforth is to have a more equitable participation in every area of the public sector wherein economic opportunities exist.”

“We put forth a call to action for your continued support of the AACCNJ, so that we may continue to advocate for a more equitable share of the state’s balance sheet, we have been a leading voice in the advocacy for the completion of this disparity study since our inception in 2007”, said Harmon. “We now claim a seat at the table to ensure that reciprocity, and recompense become a reality with what Dr. King called “the fierce urgency of Now,” on behalf of our constituents and the beloved community. Let us combat selfishness, which is self-destructive behavior, not providing opportunities for those with the capabilities to contribute to the success of the state; let us embark on a new chapter of authentic and transparent collective collaboration.

Background and timeline

Dec. 23, 2020 “The Department of the Treasury announced several key initiatives on Wednesday that will advance the Murphy Administration’s commitment to ensuring Minority-, Women-, and Veteran-Owned Businesses (MWVOB) can more fully participate in New Jersey’s multi-billion-dollar supply chain.1

“Chief among these initiatives is the commissioning of the first disparity study in 20 years to measure current spend data, which is viewed as key to identifying and opening up new opportunities for MWVOBs to contract with the State of New Jersey to provide goods and services. The disparity study has been a priority for the Murphy Administration from day one.”2

“This disparity study is not only long overdue, it is an integral part of our vision for a stronger, fairer, and more resilient, post-COVID economy that opens doors for diverse businesses to play a greater role in shaping our state’s future,” said Governor Phil Murphy. “This study will provide us with an opportunity to create a more equitable business environment, which is a win for us all.”3

“Recognizing how long it has been since the last study was conducted, we tried to ensure that this new study will capture as much data as possible, beyond just statistics that are available on our spend, but also including outreach to stakeholders and community groups as well,” said Treasurer Muoio. “This will give us the tools and the information necessary to determine where our strengths and weaknesses lie so we can implement more equitable procurement strategies moving forward. The state has a vast supply chain of goods, commodities, and professional and financial services and in a truly equitable society every qualified vendor in our state should have the opportunity to participate in the economy fueled by their tax dollars.”4

The goal, as laid out in the bid solicitation, is to research, structure, and conduct a comprehensive and legally defensible disparity study of the State’s contract awards in construction, goods, and services over a five year period (July 1, 2015 through June 30, 2020) to determine whether there is a disparity between the number of qualified minority, women, and veteran-owned businesses ready, willing, and able to perform services, and the number of vendors/contractors actually engaged to perform such services. The Disparity Study will include a review of contracts for construction, goods, commodities, and services and shall be appropriately structured so that the state may, if appropriate, use the information to fashion race- and/or gender-neutral, and if necessary, race- and gender-conscious methods of achieving those goals for state contracts and employment by state vendors.5

The State of New Jersey held a series of virtual business community meetings on Sept. 20, 21, and 22, 2021 regarding its disparity study. AACCNJ’s member organizations participated in the meetings conducted by Mason Tillman Associates.

Jan. 9, 2023. “In spite of so many challenges, black businesses continue as the fastest-growing business segment of our country, so we remain very hopeful. With 94% of the black vote going to Governor Murphy in his last statewide election, we look forward to learning more about the tangible actions he will take in the second half of his final term to help level the playing field for all of us, said John E. Harmon, Sr. “Notably, we eagerly anticipate the announcement and projected timeline on a statewide Disparity Study that will further identify barriers and inequalities within our communities and take them head on.”

“These times remind me of words that were expressed by the late Dr. Martin Luther King, Jr.: “The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy,” stated John E. Harmon, Sr. “We are now in those times once again and the optimal outcomes can be realized when the rules of engagement are clearly defined, and the playing field is available to all to compete effectively with value being the declared goal. In conclusion, the data in this study confirms that Black people are still at the bottom.”

 

1 https://www.nj.gov/treasury/news/2020/12232020.shtml

2 https://www.nj.gov/treasury/news/2020/12232020.shtml

3 https://www.nj.gov/treasury/news/2020/12232020.shtml

4 https://www.nj.gov/treasury/news/2020/12232020.shtml

 

About the African American Chamber of Commerce of New Jersey

The AACCNJ performs an essential role in the economic viability of New Jersey. While providing a platform for New Jersey’s African American business leaders, to speak with a collective voice, the AACCNJ advocates and promotes economic diversity fostering a climate of business growth through major initiatives centering on education and public policy. The Chamber serves as a proactive advocacy group with a 501(c) 3 tax exemption, which is shared by the National Black Chamber of Commerce.

Categories
Healthcare Lifestyle Local News News Now! Science

Opdivo (nivolumab) plus Yervoy (ipilimumab) reduced the risk of disease progression or death by 79% versus chemotherapy in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer in CheckMate -8HW trial

First presentation of data from the Phase 3 randomized trial shows statistically significant and clinically meaningful improvement in progression-free survival with Opdivo plus Yervoy compared to chemotherapy as first-line treatment in this patient population

 

Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first-line treatment in MSI-H/dMMR mCRC

 

Late-breaking data to be featured in oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium and highlighted as part of official Congress press program

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO—Bristol Myers Squibb (NYSE: BMY) on Monday announced results from the Phase 3 CheckMate -8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

 

The dual immunotherapy combination of Opdivo and Yervoy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), with a reduction in the risk of disease progression or death by 79% (Hazard Ratio [HR]: 0.21; 95% Confidence Interval [CI]: 0.14-0.32; p<0.0001) compared to chemotherapy in patients with centrally confirmed MSI-H/dMMR mCRC.

These late-breaking data (Abstract #LBA768) will be featured in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on Saturday, January 20 at 9:15 a.m. Pacific Time and will be highlighted as part of the Congress’ official press program.

 

Improvement in PFS was noted beginning at approximately three months and was sustained throughout. Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8). Consistent PFS benefit was observed across all pre-specified subgroups, including patients with KRAS or NRAS mutations, and those with baseline liver, lung, or peritoneal metastases.

 

The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients in the Opdivo plus Yervoy arm and 48% of patients in the chemotherapy arm. Any grade TRAE-related discontinuation was 17% in the Opdivo plus Yervoy arm and 32% in the chemotherapy arm.

 

“Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, M.D., Head of the Medical Oncology Department, Sorbonne University and Hospital Saint-Antoine, Paris, France. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial. These results demonstrate the meaningful efficacy of this combination with practice-changing potential for this patient population.”

 

Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first line treatment in MSI-H/dMMR mCRC.

 

“With research from the full CheckMate clinical development program, BMS has revolutionized the oncology landscape and helped change survival expectations for people with cancer. Today, with these data from CheckMate -8HW, we showed that Opdivo plus Yervoy reduced the risk of disease progression or death by an unprecedented 79%,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “These results build on the benefit of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer as previously demonstrated in CheckMate -142 and reinforce our commitment to exploring the potential of these therapies to help more patients in need.”

 

CheckMate -8HW is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints, including overall survival (OS).

 

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

 

About CheckMate -8HW

CheckMate -8HW (NCT04008030) is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

 

Approximately 830 patients were randomized to receive either Opdivo monotherapy (Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W), or investigator’s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the first line setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy. The trial also includes several secondary safety and efficacy endpoints, including overall survival (OS).

 

The study is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints.

 

About MSI-H or dMMR Colorectal Cancer

Colorectal cancer (CRC) is a cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined.

 

Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors; they are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle.

 

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

Read full story here

Categories
Culture Education Environment Lifestyle Local News Programs & Events

Lenape Storytelling with Chief Bluejay to commune at D&R Greenway’s Discovery Center at Point Breeze in Bordentown

 The public is invited to an afternoon of Lenape Storytelling on Sunday, Jan. 28  from 2 to 4 p.m. at D&R Greenway Land Trust’s Discovery Center at Point Breeze, located at 101 East Park St., Bordentown, N.J.

 

The public is invited to enjoy an afternoon of storytelling in the tradition of the Lenape, the First People, at D&R Greenway’s Discovery Center at Point Breeze on Sunday, Jan. 28, from 2 p.m. to  4 p.m.

Photo: Visit the Discovery Center at Point Breeze
Photo: Chief Bluejay and Uma Cinnamon in the Peoples Room at the Discovery Center

 

The Discovery Center was created by D&R Greenway Land Trust in a renovated historic home that belonged to the exiled King of Spain Joseph Napoleon Bonaparte’s gardener in the early 1800s. The house will be open with exhibits about the history, land and people of Point Breeze, including the Lenape and Bonaparte, birds and the Delaware River watershed. Visitors learn about the Three Sisters garden, indigenous and heritage crops that are grown in the Historic Garden at Point Breeze.

 

“Wintertime is when indigenous peoples gather to tell stories” says Barbara Michalski, known as Chief Bluejay. Of Lenape descent, she is Chief, Keeper of Culture, Storyteller and Public Speaker for the Lenape Nation of Pennsylvania.  She is a talented storyteller who shares the traditions of the Lenape to remind people that “we are still here.” Bluejay provided advice to D&R Greenway in development of the Peoples Room inside the Discovery Center at Point Breeze.  There, visitors will learn about Lenape language and read stories about land and water stewardship.  Chief Bluejay’s intention is “to stress how we should take care of Mother Earth.”

 

A landmark positioned in front of the Historic Garden at the Discovery Center at Point Breeze is a life-size sculpture of an Atlantic Sturgeon.  These huge creatures, that can grow up to 14 feet in length, were once abundant in the Delaware River but were taken to the brink of extinction due to loss of habitat.  They depend on clean water to spawn in the Delaware River.  Native Americans fished these creatures for food and used the remains as fertilizer for agricultural crops. Visitors to the open house will have an opportunity to color Sturgeon cards provided by the Delaware Riverkeeper.  The cards will be hung on our tree inside the Crown Jewels Gallery to transition the holiday tree to a “Sturgeon Family Tree” and share wishes for protecting the Atlantic Sturgeon and the Delaware River.

 

In the Natural World Room visitors will find wood carvings for sale by artist Jane “Walkingstick” Roop, of Lenape descent.  Walking Sticks, Spirit Sticks, and various carvings are available for prices ranging from $35 – $225, with a portion of the sales supporting programs at the D&R Greenway’s Discovery Center at Point Breeze.

Photo: Lenape wood carvings available for purchase at the Discovery Center

 

“This special opportunity celebrates a community of people and special features of the Delaware River watershed that are truly treasures,” says Linda Mead, D&R Greenway’s President & CEO.  “Working in partnership with Chief Bluejay, Jane Walkingstick and other members of the Lenape Nation has been an honor for me and carries out D&R Greenway’s mission to protect land and water and inspire a conservation ethic.”

 

Admission to the Storytelling program and the Discovery Center at Point Breeze is free.  A suggested donation of $10 provides the donor with a souvenir magnet or bag, and supports programs and exhibits.

 

The afternoon program is an open house format. Visitors are invited to join during the open hours for ongoing stories and activities.  The Discovery Center’s exhibits on Native Americans, King Joseph Napoleon Bonaparte, gardens, birds and the Delaware River watershed will be open to view. Registration suggested at info@drgreenway.org or call 609-924-4646.

 

####

About D&R Greenway Land Trust: D&R Greenway Land Trust is an accredited nonprofit that has reached a new milestone of over 22,000 acres of land preserved throughout central New Jersey since 1989. By protecting land in perpetuity and creating public trails, it gives everyone the opportunity to enjoy the great outdoors. The land trust’s preserved farms and community gardens provide local organic food for residents of the region—including those most in need. Through strategic land conservation and stewardship, D&R Greenway combats climate change, protects birds and wildlife, and ensures clean drinking water for future generations. D&R Greenway’s mission is centered on connecting land with people from all walks of life. www.drgreenway.org; info@drgreenway.org. Follow us on Facebook and Instagram.

Categories
Culture Economics Government Lifestyle Local News Perks

New Jersey Housing and Mortgage Finance Agency celebrates 40 years of service

TRENTON, N.J. — On Jan. 17, 2024, the New Jersey Housing and Mortgage Finance Agency (NJHMFA) celebrates its 40th anniversary.

Since its founding 40 years ago, NJHMFA’s programs have directly benefited hundreds of thousands of New Jersey residents by providing affordable housing options and vital mortgage assistance.

Through the Low-Income Housing Tax Credit program, NJHMFA has financed 70,000 apartments, over 66,000 of which are affordable to low- and moderate-income households. Another 112 new multifamily developments are underway, which together will bring online another 9,000 affordable units. NJHMFA has helped more than 10,000 families buy their first home, representing more than $2 billion in market value at the time of purchase and nearly the same again in wealth created through equity.

NJHMFA has also helped more than 56,000 families facing housing instability by providing counseling and financial assistance. Beyond the numbers, NJHMFA’s work has improved thousands of lives: families have found stable homes, neighborhoods have been revitalized, and individuals have found support in their time of greatest need. Against this backdrop, NJHMFA’s 40th anniversary commemorates not only the Agency’s work, but the substantial impact investment in New Jersey’s residents can have on our communities and our future.

“For 40 years, the New Jersey Housing and Mortgage Finance Agency has helped many thousands of New Jerseyans become new homeowners,” said Governor Murphy.

“Our Administration’s partnership with NJHMFA has been essential to creating access to more affordable housing throughout our state. As the agency reaches this incredible milestone of an anniversary, we recognize the many programs the agency has created to make the American dream attainable for so many in our state.”

“NJHMFA exists to make New Jersey housing affordable to all New Jerseyans, and for 40 years, it has delivered. We have deployed innovative programs, policies, and partnerships, becoming a nationally recognized leader in affordable housing development and producing numerous award-winning and landmark properties,” said Executive Director Melanie Walter.

“NJHMFA is proud of the positive impact that we have on the lives of all New Jerseyans, particularly those looking for apartments or first homes that are affordable to them in the communities where they want to live. We look forward to continuing to support community development and revitalization in the years ahead.”

“Congratulations to the New Jersey Housing and Mortgage Finance Agency (NJHMFA) on 40 years of progressive and innovative work making communities more diverse, and municipalities economically stronger,” said DCA Acting Commissioner Jacquelyn A. Suárez.

“Today, New Jersey families and individuals with specialized housing needs have more options when seeking safe, affordable, and stable rental housing and homeownership opportunities. Without a doubt, New Jerseyans will continue to benefit from NJHMFA’s transformative work in the future.”

NJHMFA was created by an act of the New Jersey legislature merging the New Jersey Housing Finance Agency (HFA) and the New Jersey Mortgage Finance Agency (MFA) into a single organization to house the state’s affordable housing production capacity for both multifamily and single-family housing. Today, NJHMFA oversees a multifamily production portfolio that has grown to exceed $1.3 billion each year, and an approximately $1 billion annual single-family mortgage program. Over the past 40 years, NJHMFA has become the New Jersey state allocator of the federal Low-Income Housing Tax Credit (LIHTC), the host of the state’s preeminent down payment assistance program for new homebuyers, and the administrator of federal assistance programs designed to protect homeowners against the impacts of economic downturns.

Through the LIHTC program, created in 1984, NJHMFA has financed the creation or preservation of over 75,000 affordable apartments across 1,010 properties, with 66,000 of these units already completed and another 9,000 units forthcoming. These projects have provided thousands of low- and moderate-income residents throughout the state with safe and high-quality homes, cumulatively generated billions of dollars in the direct and indirect economic impacts of new construction, supported thousands of jobs, and helped municipalities advance their community development goals.

At the same time, NJHMFA has consistently expanded homeownership opportunities for low- and moderate-income households. Since the 2017 expansion in single-family programs, NJHMFA has allocated over $100 million in down payment and closing cost assistance to approximately 10,000 first-time low-and moderate-income homebuyers. These borrowers were able to make home purchases cumulatively valued at over $2 billion. Despite the challenges of recent interest rate hikes, this initiative has continued to grow, assisting about 2,500 households in 2023 alone. That same year, NJHMFA created a program specifically tailored to the needs of first-generation homebuyers, making New Jersey one of only a handful of states to offer such assistance.

In addition to creating multifamily housing opportunities and offering access to homeownership opportunities, NJHMFA works to effectively protect quality of life throughout the state by preventing the loss of homeownership. When the housing market collapsed in 2008, NJHMFA provided more than $320 million to over 8,000 impacted homeowners, as well as housing counseling that helped struggling homeowners avoid foreclosure. More than 56,000 New Jersey families have benefitted from NJHMFA’s free housing counseling initiatives. When the COVID-19 pandemic struck, NJHMFA developed the federally funded ERMA program, which has distributed more than $150 million to help more than 5,000 homeowners avoid foreclosure so far.

As NJHMFA marks its 40th anniversary, it uses the lessons of the past to shape its clear vision for the future. The Agency seeks to expand its impact, leveraging data resources, technology, and state and federal resources to meet the many diverse housing needs in evidence across the state. It will continue building strong community and development partnerships, optimizing resources, and addressing emerging housing issues proactively. In these ways, NJHMFA will remain at the forefront of New Jersey affordability, accessibility, and sustainability, supporting NJ residents and fostering community well-being in the decades ahead.

About Us: The New Jersey Housing and Mortgage Finance Agency (NJHMFA) advances the quality of life for residents of and communities throughout New Jersey by investing in, financing, and facilitating access to affordable rental housing and homeownership opportunities for low and moderate-income families, older adults, and individuals with specialized housing needs. To learn more about NJHMFA, visit: https://NJHousing.gov/

Categories
Education Healthcare Lifestyle Local News News Now! Programs & Events Science

Bristol Myers Squibb Data at ASCO GU 2024 showcase transformative research in genitourinary cancer treatment

First presentation of results from Phase 3 CheckMate -67T trial with subcutaneous formulation of Opdivo (nivolumab and hyaluronidase) to be shared in a late-breaking oral presentation

Four-year data from CheckMate -9ER and unprecedented eight-year data from CheckMate -214 will confirm durable outcomes with Opdivo-based combinations for patients with advanced renal cell carcinoma

First disclosure of clinical outcomes from Phase 1 trial with BMS-986365 (CC-94676), the company’s first androgen receptor ligand-directed degrader in solid tumors from its targeted protein degradation platform, in metastatic castration-resistant prostate cancer

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU) to be held from Jan. 25 to 27 in San Francisco, Calif., highlighting the company’s progress in making long-term survival outcomes a possibility for more patients with genitourinary cancers, as well as showcasing potential new options and therapeutic platforms that may transform treatment paradigms across tumor types.

 

Data from 14 company-sponsored studies, investigator-sponsored studies and collaborations will be presented at the meeting.

The first presentation of data from the CheckMate -67T study will highlight the potential of a subcutaneous formulation of nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) in advanced or metastatic clear cell renal cell carcinoma (RCC). Research to be shared will also add to the evidence supporting the use of Opdivo (nivolumab)-based combinations in patients with advanced RCC, including four-year follow-up data from the CheckMate -9ER trial and eight-year results from the CheckMate -214 trial. In addition, data will be presented on an investigational androgen receptor (AR) ligand-directed degrader (LDD; BMS-986365) in metastatic castration-resistant prostate cancer (mCRPC), providing validation for the targeted protein degradation platform in solid tumors and representing one of the company’s next waves of potential registrational assets.

 

“We are excited to present our research at ASCO GU 2024, which will demonstrate not only our long-standing leadership in oncology with our work in immunotherapy, but also our commitment to developing new assets and approaches to treating cancer from our differentiated research platforms such as targeted protein degradation in an effort to provide patients with better, long-term outcomes,” said Samit Hirawat, M.D., executive vice president and chief medical officer, Drug Development, Bristol Myers Squibb.

 

“These results simultaneously showcase the ongoing success of Opdivo-based combinations in metastatic disease and our contributions to the future of cancer treatment and research. We are especially eager to share data for the first time showing the potential of our subcutaneous formulation of a proven agent, and a new mechanism of action in a difficult-to-treat tumor type – both of which could have a tremendous impact on existing standards of care and the patient experience.”

 

Key data being presented by Bristol Myers Squibb at ASCO GU 2024 include:

  • First disclosure of pharmacokinetics, efficacy and safety results from the Phase 3 CheckMate -67T trial with subcutaneous nivolumab (nivolumab and hyaluronidase) being presented in a late-breaking oral session. This marks the first presentation of data evaluating subcutaneous nivolumab compared to its intravenous formulation.
  • Eight-year data from the Phase 3 CheckMate -214 study with Opdivo plus Yervoy (ipilimumab) showing ongoing survival and response benefits over sunitinib among intermediate- and poor-risk patients with advanced RCC, as well as among all randomized patients. These data represent the longest survival benefit vs. sunitinib reported in patients with previously untreated advanced or metastatic RCC.
  • Four-year follow-up data from the Phase 3 CheckMate -9ER trial evaluating Opdivo in combination with Exelixis’ CABOMETYX (cabozantinib). These data demonstrate meaningful, long-term efficacy benefits seen with the combination therapy over sunitinib and reinforce it as a standard of care for previously untreated advanced RCC.
  • First presentation of clinical outcomes from the company’s targeted protein degradation platform in solid tumors with Phase 1 data from BMS-986365 (CC-94676), an oral drug selectively targeting AR. BMS-986365 induces effective and durable suppression of AR signaling, overcomes resistance to existing AR pathway inhibitors (ARPI) therapies and shows promising clinical activity in heavily pre-treated patients with mCRPC across wildtype, amplified and mutant AR status, highlighting this asset as the potential best-in-class AR-ligand directed degrader that may help overcome resistance to standard of care ARPIs in patients with mCRPC, a difficult-to-treat tumor type.

 

Summary of Presentations:

Abstract Title

Author

Presentation

Type/#

Session Title

Session

Date/Time (ET)

Prostate Cancer

First-in-human phase 1 study of CC-94676, a first-in-class androgen receptor (AR) ligand-directed degrader (LDD), in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Dana Rathkopf

Poster

Abstract #134

Poster Bd. #F5

Poster Session A: Prostate Cancer

Thursday, January 25

2:30 PM – 4:00 PM

Renal Cell Carcinoma

Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T.

Saby George

Oral

Abstract #LBA360

Oral Abstract Session C: Renal Cell Cancer

Saturday, January 27

11:10 AM – 12:45 PM

Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Results from 55-month follow-up of the CheckMate 9ER trial.

Maria Teresa Bourlon

Rapid Oral

Abstract #362

Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers

Saturday, January 27

4:00 PM – 5:15 PM

Nivolumab plus ipilimumab (NIVO+IPI) vs sunitinib (SUN) for first-line treatment of advanced renal cell carcinoma (aRCC): Long-term follow-up data from the phase 3 CheckMate 214 trial.

Nizar Tannir

Rapid Oral

Abstract #363

Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers

Saturday, January 27

4:00 PM – 5:15 PM

Adjuvant nivolumab monotherapy vs placebo for localized renal cell carcinoma at high risk of relapse after nephrectomy: Results from Part B of the randomized, phase 3 CheckMate 914 trial.

Robert Motzer

Oral

Abstract #LBA358

Oral Abstract Session C: Renal Cell Cancer

Saturday, January 27

11:10 AM – 12:45 PM

Treatment patterns and costs among patients with metastatic renal cell carcinoma (mRCC) in the United States: A real-world study using integrated claims and clinical data.

Daniel Geynisman

Poster

Abstract #398

Poster Bd. #F22

Poster Session C: Renal Cell Cancer; Adrenal, Penile, and Testicular Cancers

Saturday, January 27

10:00 AM – 11:00 AM

Urothelial Carcinoma

Estimating the impact of adjuvant treatment with nivolumab on long-term survivorship rates compared with surveillance: Analyses of disease-free survival (DFS) from the phase 3 CheckMate-274 trial.

Daniel Geynisman

Oral

Abstract #528

Role of Immunotherapy in Advanced Urothelial Carcinoma: Sequencing, Pairing, Rechallenging

Friday, January 26

5:30 PM – 6:45 PM

Characteristics of patients (pts) with muscle-invasive urothelial carcinoma (MIUC) who received adjuvant nivolumab (NIVO) or adjuvant platinum-based chemotherapy (CHEMO) in the real-world (RW) setting.

Alex Chehrazi-Raffle

Poster

Abstract #565

Poster Bd. #E14

Poster Session B: Urothelial Carcinoma

Friday, January 26

2:30 PM – 4:00 PM

 

 

All abstracts except late-breaking abstracts will be available on ASCO’s digital program at 5:00 PM Eastern Time (ET) on January 22, 2024. All late-breaking abstracts will be available on ASCO’s digital program at 10:00 AM ET on their day of presentation at the meeting.

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.

 

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

 

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

 

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

 

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

Read full story here