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Fork & Good hosts first ever tasting of hybrid cultivated meat at Davos

The food startup shared its product with thought leaders and local residents at its first large-scale tasting since the launch of its pilot facility last year

 

 

DAVOS, Sz. — (BUSINESS WIRE) — On Jan. 16, heads of state, industry experts and business leaders gathered for the annual World Economic Forum conference at Davos.

 

At the same time, a smaller, though no less consequential, event took place just 10 minutes away at Sonas Irish Pub. Food startup Fork & Good conducted the city’s first blind tasting of hybrid cultivated meat to gather feedback from an eclectic group of 40 people.

 

Participants each received two small dishes distinguished by blue and yellow stickers. One contained 100% conventional pork and the other a blend of 30% cultivated and 70% conventional pork. (Willing vegetarians also had a chance to enjoy dumplings made with a blend of plant and cultivated pork).

 

“Mixing cultivated meat with conventional meat has many advantages,” said Fork & Good Chief Scientific Officer Gabor Forgacs.

 

“It helps alleviate the rising supply chain and environmental challenges meat producers face. It also allows for the gradual introduction of cultured meat through products consumers are already used to.”

 

Perhaps most importantly, it tastes just like meat — because it is 100% meat. As Fork & Good co-founders expected, participants at the blind tasting found no major difference between the two samples. An informal poll after the tasting showed more than half of the group preferred the 30/70 blend over conventional meat on its own. The group was equally split when asked to guess which dish contained cultivated meat.

 

The tasting was led by Fork & Good CEO Niya Gupta, who said, “We are aiming to serve everyone everywhere with affordable meat so it’s exciting to get input in this open and democratic way. We had everyone, from an American professor to a Swedish nonprofit worker to a Chinese student — even a regular Swiss person walking in off the street looking for a beer. Their feedback has been critical to us as we continue our product development journey.”

 

One of the participants, global data science leader Dr. Richard Kerr, said, “I wasn’t able to tell the difference between the samples, to the point that I thought it was going to be revealed that all the samples were 100% cultured. I love the idea, and will continue to follow [Fork & Good’s] progress with interest.”

 

The lunchtime tasting was a part of UnDavos, an informal entrepreneurship-focused gathering that takes place the same week as the WEF conference. Mark Turrell, founder of UnDavos and CTO of Fresh Solutions AI, invited Fork & Good to present their product at a “meal for the future” event.

 

“It was amazing to physically experience technology being integrated into our food — the food in our mouths,” Turrell said.

 

In addition to the blind tasting, Fork & Good was invited to the main WEF conference as a Technology Pioneer, one of just 100 early-stage startups developing innovative technologies to address global challenges. Gupta participated in back-to-back meetings and roundtables, including a bilateral meeting with one of the world’s largest meat producers who couldn’t tell the difference between conventional meat and Fork & Good’s hybrid cultivated meat.

 

Founded in 2018, Fork & Good launched its pilot facility in Jersey City, New Jersey. The facility is already capable of producing six to ten times more meat per square foot than is currently possible by conventional means. Fork & Good’s cultivated meat is ready for market, pending regulatory approval by the FDA and USDA.

 

ABOUT FORK AND GOOD

From its facility in Jersey City, Fork & Good is on a mission to grow the best of meat for everyone, everywhere. The company takes a novel approach to cultivating meat by growing muscle cells directly in proprietary bioreactors for maximum flavor and nutritional value—while drastically reducing the amount of land and water used in conventional livestock production. The team has 150+ years of combined experience that spans food, agriculture, and science, and is committed to helping build the industry in a safe, transparent way. Learn more at: www.forkandgood.com.

 

Contacts

Emily Bogan, Business Operations Manager

Email: hello@forkandgood.com
Phone: (201) 201-1392

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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

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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.

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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.

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US Patent Office invalidates Seagen patent in dispute between Daiichi Sankyo and Seagen

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Daiichi Sankyo Co., Ltd. (TSE: 4568) (hereinafter, Daiichi Sankyo) announced today that the U.S. Patent and Trademark Office (U.S. PTO) rendered a Final Written Decision invalidating all claims of Seagen Inc.’s U.S. patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR).

“We are pleased that the U.S. PTO invalidated all challenged claims of the ’039 patent,” said Naoto Tsukaguchi, Corporate Officer and General Counsel, Daiichi Sankyo.

 

On Dec. 23, 2020, Daiichi Sankyo filed a PGR petition with the U.S. PTO contesting the patentability of certain claims of the ’039 patent. On April 7, 2022, the U.S. PTO granted Daiichi Sankyo’s request to institute the PGR.

 

The ’039 patent was the sole patent-in-suit in the infringement litigation between the parties in the U.S. District Court for the Eastern District of Texas, an appeal of which is now pending in the U.S. Court of Appeals for the Federal Circuit.

 

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

 

Media Contacts:

Global/Japan:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

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Kim Wix

Daiichi Sankyo, Inc.

kwix@dsi.com
+1 908 992 6633

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

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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

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Phibro Animal Health Corporation to host webcast and conference call on second quarter results

TEANECK, N.J. — (BUSINESS WIRE) — Phibro Animal Health Corporation (Nasdaq: PAHC) expects to announce its second quarter financial results on Wednesday, Feb. 7, 2024, after the market closes. Phibro management will host a conference call and webcast on Thursday, Feb. 8, 2024, at 9 a.m. ET.

 

Interested parties are invited to listen to the conference call and view the presentation slides by visiting https://investors.pahc.com. The discussion will also be available by dialing +1 (888) 330-2022 in the U.S. and Canada, or +1 (365) 977-0051 for international callers. Provide the conference ID 3927884.

 

A replay of the webcast will be available approximately two hours after the conclusion of the live event. To access the webcast recording, visit https://investors.pahc.com.

 

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a leading global diversified animal health and mineral nutrition company. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. For further information, please visit www.pahc.com.

 

Our filings with the Securities and Exchange Commission are available online at www.sec.gov, www.pahc.com or on request from the company.

Contacts

Richard Johnson

Chief Financial Officer, Phibro Animal Health Corporation

+1-201-329-7300

investor.relations@pahc.com

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CitiusTech named a Leader and a Star Performer in Everest Group’s Payer Digital Services PEAK Matrix® Assessment 2023

PRINCETON, N.J. — (BUSINESS WIRE) — #AI—CitiusTech, a leading provider of healthcare technology services, solutions, and platforms, announced that it has been positioned as a Leader and a Star Performer in the Everest Group’s Payer Digital Services PEAK Matrix® Assessment for 2023.

 

 

The report analyzed 32 leading healthcare IT service providers on capabilities in healthcare payer digital services and market impact. It focused on payer digital services market size and growth, digital services themes for healthcare payers, assessment of the service providers on several capabilities and market success-related dimensions, and Everest Group’s independent remarks on service providers.

 

“It is with great pride that we announce our designation as both a Leader and a Star Performer within the Everest Group’s Healthcare Payer Digital Services PEAK Matrix. Healthcare Payers currently navigate a myriad of substantial challenges, ranging from traditional issues such as labor intensity, isolated solutions, accrued technological deficits, to modern challenges such as Medicare Advantage business models, vertical integration, interoperability, value-based care, and AI, among others. This accolade underscores our continued disruption in the Payer Digital Services sector over the last six years since forming the unit and affirms our commitment to enhancing value to our clients in these multi-faceted domains,” said Shyam Karunakaran, EVP – Health Plans, CitiusTech.

 

“With the healthcare industry undergoing significant changes, payers are adopting digital technologies such as AI, cloud, and analytics to enhance their business outcomes,” stated Priya Sahni, Practice Director, Everest Group. “With its comprehensive range of offerings throughout the value chain, CitiusTech has empowered its clients to achieve operational efficiency and cost-effectiveness. The company’s profound domain expertise, high-quality talent pool, and strategic acquisitions and partnerships (e.g., OutSystems, Databricks) aimed at enhancing its capabilities have led to its positioning as a Leader and a Star Performer in Everest Group’s Healthcare Payer Digital Services PEAK Matrix® Assessment for 2023.”

 

As per the report, CitiusTech has demonstrated considerable year-on-year (YoY) growth in payer digital services revenue, driven by engagements with mid-sized and large payer accounts. Its domain and technical expertise, and innovative price constructs have led to high client satisfaction. The report also notes that CitiusTech has made significant investments to augment its digital capabilities in the areas of big data and cloud; and launched a cloud platform, Perform+ Datascale, to increase interoperability and streaming of data exchanges. The company’s other proprietary solutions include PERFORM+ Contracts, PERFORM+ Stars, PERFORM+ Regulatory, MRFEngine, and RealSight.

 

Everest Group’s Payer Digital Services PEAK Matrix® assessment report notes that providers are forging industry-specific partnerships and acquiring relevant companies to support enterprises on their digital transformation journeys. This has driven the need for research and market intelligence on demand and supply trends in healthcare payer digital services. Everest Group’s healthcare ITS research program addresses this market need by analyzing demand themes and service provider capabilities in healthcare payer digital services.

 

More recently, CitiusTech has a generative AI Centre of Excellence that helps healthcare clients adopt and scale gen AI and solve complex problems of service delivery, operations, and customer business transformation for health plans. The company’s internal crowd-sourced initiative, Innovation for Accelerated Growth (IAG 2.0) aims at nurturing innovation across themes such as predictive analytics, population health, generative AI, interoperability, quality management and IoT. The strategic acquisition of industry-leading, healthcare-focused Salesforce services and solutions company, Wilco Source, expands CitiusTech’s Salesforce offerings in the areas of member experience, care management, digital front door, and patient services.

 

To know more about CitiusTech’s Payer Digital Services offerings, please visit Health Plans.

 

A complimentary custom copy of the report can be found here.

 

About CitiusTech

CitiusTech is a leading provider of digital technology and consulting services to payer, provider, medical technology, and life sciences companies. With over 8,500 healthcare technology professionals worldwide, CitiusTech powers healthcare digital innovation, business transformation and industry-wide convergence for over 140 organizations, through next-generation technologies, solutions, and products. Key focus areas include healthcare interoperability, secure data management, quality and performance analytics, real world data, clinical research optimization, virtual trials, value-based care, patient experience, medical imaging, connected health, payer-provider convergence, care coordination and population health management. CitiusTech’s cutting-edge technology expertise, deep healthcare domain expertise and a strong focus on digital transformation enables healthcare and life sciences companies to reinvent themselves to deliver better outcomes, accelerate growth, drive efficiencies, and ultimately make a meaningful impact to patients. Follow CitiusTech on Twitter or LinkedIn.

Contacts

Saviera Barretto Saviera.Barretto@citiustech.com

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FDA approves Merck’s KEYTRUDA® (pembrolizumab) plus chemoradiotherapy as treatment for patients with FIGO 2014 Stage III-IVA cervical cancer

KEYTRUDA is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients

Approval marks third FDA-approved indication for KEYTRUDA in cervical cancer and 39th indication for KEYTRUDA in the US

 

 

RAHWAY, N.J. — (BUSINESS WIRE) — $MRK #MRK — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, on Monday announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

 

The approval is based on data from the Phase 3 KEYNOTE-A18 trial, in which KEYTRUDA plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group. This approval marks the third indication for KEYTRUDA in cervical cancer and the 39th indication for KEYTRUDA in the U.S.

 

“Today’s approval of KEYTRUDA plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Dr. Bradley Monk, oncologist and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine. “This KEYTRUDA-based regimen offers a new treatment option for these patients, so today’s approval has important implications for the way we treat them moving forward.”

 

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

 

“Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “This approval provides newly diagnosed patients with an anti-PD-1-based treatment option that has the potential to reduce the risk of disease progression or death compared to chemoradiotherapy alone.”

 

In the U.S., KEYTRUDA has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test; and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

 

Study design and additional data supporting the approval

KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT04221945) sponsored by Merck and conducted in collaboration with the European Network for Gynaecological Oncological Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG) investigating KEYTRUDA in combination with CRT (cisplatin and external beam radiotherapy [EBRT] followed by brachytherapy [BT]). The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer. There were 596 patients with FIGO 2014 Stage III-IVA cervical cancer (tumor involvement of the lower vagina with or without extension onto pelvic sidewall or hydronephrosis/non-functioning kidney or has spread to adjacent pelvic organs) with either node-positive or node-negative disease, and 462 patients with FIGO 2014 Stage IB2-IIB cervical cancer (tumor lesions >4 cm or clinically visible lesions that have spread beyond the uterus but have not extended onto the pelvic wall or to the lower third of vagina) with node-positive disease; two patients had FIGO 2014 Stage IVB disease. Patients were randomized (1:1) to receive either:

  • KEYTRUDA (200 mg intravenously [IV]) every three weeks (Q3W) for five cycles concurrent with cisplatin (40 mg/m2 IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by KEYTRUDA (400 mg IV) every six weeks (Q6W) for 15 cycles;
  • Placebo IV Q3W for five cycles concurrent with cisplatin (40 mg/m2 IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by placebo IV Q6W for 15 cycles.

 

Treatment continued until RECIST v.1.1-defined progression of disease as determined by investigator or unacceptable toxicity. Assessment of tumor status was performed every 12 weeks from completion of CRT for the first two years, followed by every 24 weeks in year three, and then annually. The major efficacy outcome measures were PFS as assessed by investigator according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, or histopathologic confirmation, and overall survival (OS).

 

The trial demonstrated a statistically significant improvement in PFS in the overall population. In an exploratory subgroup analysis for the 462 patients (44%) with FIGO 2014 Stage IB2-IIB disease, the PFS HR estimate was 0.91 (95% CI, 0.63-1.31), indicating that the PFS improvement in the overall population was primarily attributed to the results seen in the subgroup of patients with FIGO 2014 Stage III-IVA disease. Overall survival data were not mature at the time of PFS analysis, with 10% deaths in the overall population.

 

In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303). Median PFS was not reached in either arm. The 12-month PFS rate was 81% (95% CI, 75-85) for KEYTRUDA plus CRT versus 70% (95% CI, 64-76) for placebo plus CRT.

 

The median duration of exposure to KEYTRUDA was 12.1 months (range, 1 day to 27 months). Fatal adverse reactions occurred in 1.4% of 292 patients receiving KEYTRUDA in combination with chemoradiotherapy, including one case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with CRT. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with CRT. Serious adverse reactions occurring in ≥1% of patients included urinary tract infection (2.7%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 7% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 43% of patients; the most common adverse reactions leading to interruption of KEYTRUDA (≥2%) were anemia (8%), COVID-19 (6%), SARS-CoV-2 test positive (3.1%), decreased neutrophil count (2.7%), diarrhea (2.7%), urinary tract infection (2.7%), and increased alanine aminotransferase (2.4%). The most common adverse reactions (≥10%) among patients receiving KEYTRUDA were nausea (56%), diarrhea (50%), vomiting (33%), urinary tract infection (32%), fatigue (26%), hypothyroidism (20%), constipation (18%), decreased appetite and weight loss (17% each), abdominal pain and pyrexia (12% each), hyperthyroidism, dysuria and rash (11% each), and pelvic pain (10%).

 

About cervical cancer

Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the U.S. and around the world. Cervical cancer is the fourth most common cancer in women globally. In the U.S., it is estimated there were approximately 13,960 new cases of invasive cervical cancer and about 4,310 deaths from cervical cancer in 2023.

 

About KEYTRUDA® (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

 

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

 

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Cervical Cancer

KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.

Selected Important Safety Information for KEYTRUDA

 

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

 

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. 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 KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, 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 adverse reactions are not controlled with corticosteroid therapy.

 

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

 

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

 

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

 

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus 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. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

 

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

 

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

 

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. 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 indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

 

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

 

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

 

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-M

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

John Infanti

(609) 500-4714

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

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Beauty Hype: World’s most expensive bird droppings better than Botox!

Better than Botox: Many celebrities swear by it – over 400 years old recipe

NEW YORK — It’s supposed to work better than Botox, and after just a few minutes, you look 10 years younger. The story about it from “Asami Geisha” goes back to the 17th century and comes from Japan.

 

On special farms, nightingales produce valuable feces. The songbirds are fed exclusively with plant seeds. The feces contain the urea known in cosmetics and the enzyme guanine.

 

The nightingales’ feces are disinfected by ultraviolet light and then ground into a fine powder. The effect on the skin is instantaneous, and you’re left with a peachy complexion.

 

More than 300 years ago, geishas used “Asami Geisha” very successfully to regenerate and rebuild their skin bleached with lead and zinc.

 

Numerous celebrities all over the world admire the radiant skin of Japanese women. “Asami Geisha” is a pure natural cosmetic and does not require any chemical additives.

 

But if you want to enjoy these valuable cosmetics, you have to dig deep into your pocket. 50 ml of “Asami Geisha” costs an incredible  Euro 490. This makes “Asami Geisha” by far the most expensive bird droppings in the world.

 

British journalist Claudia Cornell tested the cosmetics for Mail Online. Her conclusion: “Even after two days, my skin looked radiant, and my girlfriend thought I had had Botox injections. I’m more than satisfied with the result.”

Source:

https://www.dailymail.co.uk/femail/article-2641957/The-cringe-inducing-facial-The-good-news-beats-Botox-The-bad-news-birds-mess.html

 

More information can be found at: www.asamigeisha.com