Category: Healthcare

Expanded Access Program Established for Patients in the U.S. Who May Benefit from Investigational Therapy While Application is Under Review

RARITAN, N.J.–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The application marks the first-ever regulatory submission for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations.¹ The Company has also established an expanded access program (EAP) [NCT04599712]² for patients in the U.S. who may be eligible to obtain access to amivantamab during review of the BLA. For information about Janssen’s pre-approval access program, visit https://www.janssen.com/compassionate-use-pre-approval-access.

Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications.^3,4,5,6 In March 2020, amivantamab received Breakthrough Therapy Designation from the FDA for this population.⁷

“This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programs.”

The BLA submission for amivantamab is based on data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-center, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib*, a novel third-generation EGFR tyrosine kinase inhibitor (TKI)⁸, in adult patients with advanced NSCLC.⁹ In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumors Version 1.1** (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, as well as the safety profile of amivantamab.^8,10 Early data about amivantamab as a monotherapy treatment in patients with NSCLC with EGFR exon 20 insertion mutations were presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program (Abstract #9512).¹⁰

“Lung cancer remains the leading cause of cancer deaths worldwide. Given this significant unmet need, we at Johnson & Johnson are committed to improving outcomes for patients diagnosed with this complex, deadly disease. With today’s submission for amivantamab, we are one step closer to that goal,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “We are steadfast in our focus to advance novel therapeutics and medicines that will transform the trajectory of some of the most challenging and deadly diseases of our time, including lung cancer.”

EGFR mutations, leading to uncontrolled cancer cell growth and division¹¹, are some of the most common mutations in NSCLC.¹² EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation.¹³ However, EGFR exon 20 insertion mutations are also often undetected.¹³ Next Generation Sequencing (NGS) is effective at detecting EGFR exon 20 insertion mutations and broader use of NGS can help to detect these mutations.¹⁴ Cancer driven by EGFR exon 20 insertion mutations is generally insensitive to approved EGFR TKI treatments and, in addition, carries a worse prognosis compared with cancer driven by more common EGFR mutations, including exon 19 deletions/L858R substitutions.¹⁵ Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months¹⁶, which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months.¹⁷

*In 2018, Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

**RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same, or get bigger.

About Amivantamab

Amivantamab is an investigational, fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.^3,4,5,6 Amivantamab is pending regulatory review as a potential treatment for patients with NSCLC with EGFR exon 20 insertion mutations whose tumors typically do not respond to current standard of care. Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab. The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody^® technology platform.

About the Amivantamab Expanded Access Program Protocol (EAP)

The amivantamab EAP is for U.S. patients 18 years of age or older who have histologically or cytologically confirmed unresectable or metastatic NSCLC with an EGFR exon 20 insertion mutations who are not amenable to curative therapy and whose disease has progressed during or after current standard of care platinum-based chemotherapy, who may benefit from treatment with amivantamab prior to its potential FDA approval.² The EAP has specific inclusion and exclusion criteria for patients to be considered for enrollment in the program, and patients must not be eligible for another amivantamab study.² Interested patients should contact their physician to discuss whether they may be a candidate for amivantamab through the EAP.² Additional information about the expanded access protocol can be found on clinicaltrials.gov (NCT04599712) and at https://www.janssen.com/compassionate-use-pre-approval-access.

About Non-Small Cell Lung Cancer (NSCLC)

Worldwide, lung cancer is the most common cancer, and NSCLC makes up 80 to 85 percent of all lung cancers.^18,19 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.¹⁹ Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.¹¹ EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.²⁰ The five-year survival rate for all patients with metastatic NSCLC with EGFR mutations treated with EGFR TKIs is less than 20 percent.^21,22 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with common EGFR mutations.¹¹

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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DuoBody^® is a registered trademark of Genmab A/S.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC or any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

¹ Remon, J et al. EGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins. Cancer Treatment Reviews. 90 (2020).

² ClinicalTrials.gov. Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT04599712?term=amivantamab&draw=2&rank=2. Accessed December 2020.

³ Grugan et al. MAbs. 2017;9(1):114-126

⁴ Moores et al. Cancer Res. 2016;76(13)(suppl 27216193):3942-3953.

⁵ Yun et al. Cancer Discov. 2020;10(8):1194-1209.

⁶ Vijayaraghavan et al. Mol Cancer Ther. 2020;19(10):2044-2056.

⁷ Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer. https://www.jnj.com/janssen-announces-u-s-fda-breakthrough-therapy-designation-granted-for-jnj-6372-for-the-treatment-of-non-small-cell-lung-cancer. Accessed December 2020.

⁸ Ahn, J. et al. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1–2 study. Lancet Oncology. 2019. 20 (12): 1681-1690.

⁹ ClinicalTrials.gov. Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed December 2020.

¹⁰ Park, K. et al. Amivantamab, an Anti-EGFR-MET Bispecific Antibody, in Patients with EGFR Exon 20 Insertion-Mutated NSCLC. https://meetinglibrary.asco.org/record/184802/abstract. Accessed December 2020.

¹¹ Oxnard, JR et. al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.

¹² Wong, W. et al. Prognostic value of EGFR 19-del and 21-L858R mutations in patients with non-small cell lung cancer. Oncol Lett. 2019 Oct; 18(4): 3887–3895.

¹³ Riess JW, Gandar DR, Frampton GM, et al.Diverse EGFR Exon 20 insertions and co-occurring molecular alterations identified by comprehensive genomic profiling of NSCLC. J Thorac Oncolo. 2018;13(10):1560-1568. 10.1016/j.jtho.2018.06.019.

¹⁴ Chen D, Song Z, Cheng G. Clinical efficacy of first-generation EGFR‑TKIs in patients with advanced non‑small‑cell lung cancer harboring EGFR exon 20 mutations. Onco Targets Ther. 2016;9:4181‑4186

¹⁵ Vyse, S., Huang, P.H. Targeting EGFR exon 20 insertion mutations in non-small cell lung cancer. Sig Transduct Target Ther 4, 5 (2019).

¹⁶ Dersarkissian M, Bhak R, Lin H, Li S, Cheng M, Lax A, et al. Real-World Treatment Patterns and Survival in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations. Abstract presented at: World Conference on Lung Cancer; Sep 9, 2019; Barcelona, Spain.

¹⁷ Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50.

¹⁸ The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed December 2020.

¹⁹ American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed December 2020.

²⁰ Zhang et al 2016 (Oncotarget, Vol. 7, No. 48) study which estimated prevalence of EGFR mutations across various patient subgroups, including Asians.

²¹ Howlader N, Noone AM, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site

²² Lin JJ, Cardarella S, Lydon CA, Dahlberg SE, Jackman DM, Jänne PA, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.

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ENGLEWOOD CLIFFS, N.J.–(BUSINESS WIRE)–Unilever announced today that it has signed an agreement to acquire SmartyPants Vitamins, a U.S.-based Vitamin, Mineral & Supplement company.

Based in Los Angeles, SmartyPants Vitamins was founded in 2011 by entrepreneurs Courtney Nichols Gould and Gordon Gould, who set out to create a comprehensive supplement made from premium ingredients to support the wellbeing needs of children and adults.

SmartyPants Vitamins has a simple yet powerful promise: to be smart, simple and true. SmartyPants works with non-GMO certified ingredients and a range of sustainably sourced bio-available nutrients. Their product range is free from synthetic colors, artificial flavors, sweeteners and preservatives.

Peter Ter Kulve, President of Health & Wellbeing at Unilever, said: “SmartyPants Vitamins complements Unilever’s portfolio of brands (Horlicks, OLLY, Equilibra and Liquid I.V) in the functional nutrition and supplement segment. We are excited to work with co-founders Courtney and Gordon and their team to grow their innovative and data driven business model.”

Rooted in the belief that good health should be made accessible to everybody, SmartyPants Vitamins has a long-standing partnership with non-profit organization, Vitamin Angels, to provide life-changing vitamins for mothers, expectant mothers, and children in need worldwide.

Fabian Garcia, President of Unilever North America, said: “We are delighted to welcome SmartyPants Vitamins to the Unilever family and our portfolio of purpose-led brands. SmartyPants Vitamins aligns strongly with our mission to improve the health and wellbeing of consumers and empower people to take charge of their health with solutions they can understand and trust.”

Courtney Nichols Gould & Gordon Gould, Co-founders and Co-CEO’s of SmartyPants Vitamins, said: “From the start, SmartyPants Vitamins has been about family, authenticity and a core commitment to our collective well-being. We are excited to work with Unilever to grow the SmartyPants brand.”

Terms of the deal were not disclosed. The acquisition is subject to regulatory approvals and customary closing conditions.

For more information on Unilever North America and its brands visit: www.unileverusa.com

About SmartyPants Vitamins

Since 2011, SmartyPants has led the supplement industry in designing and manufacturing comprehensive, multifunctional supplements in a variety of easy-to-take formats for the whole family. Scientifically-formulated, made with premium, responsibly-sourced ingredients and delightful to take, their products are made in North America are free of any synthetic colors, artificial flavors, artificial sweeteners, or preservatives, and are third-party lab tested. In partnership with Vitamin Angels, SmartyPants Vitamins has reached over 14 million mothers and children worldwide with nutrient grants, with a goal of reaching 100 million by 2025. SmartyPants Vitamins can be found in more than 30,000 stores across the country including the world’s leading specialty, club and online retailers including: Amazon, Costco, Target, Walmart, Whole Foods Market, Walgreens, and many more. For more information, please visit https://www.smartypantsvitamins.com/

About Unilever North America

Unilever is one of the world’s leading suppliers of Beauty & Personal Care, Home Care, and Foods & Refreshment products with sales in over 190 countries and reaching 2.5 billion consumers a day. In the United States and Canada, the portfolio includes brand icons such as: Axe, Ben & Jerry’s, Breyers, Degree, Dollar Shave Club, Dove, Hellmann’s, Klondike, Knorr, Lever 2000, Lipton, Love Beauty and Planet, Magnum, Nexxus, Noxzema, Pond’s, Popsicle, Pure Leaf, Q-tips, Seventh Generation, Simple, Sir Kensington’s, St. Ives, Suave, Talenti Gelato & Sorbetto, TAZO, TIGI, TRESemmé and Vaseline. All of the preceding brand names are trademarks or registered trademarks of the Unilever Group of Companies.

Unilever’s Sustainable Living Plan (USLP) underpins the company’s strategy and commits to:

• Helping more than a billion people take action to improve their health and well-being by 2020.

• Halving the environmental impact of our products by 2030.

• Enhancing the livelihoods of millions of people by 2020.

The USLP creates value by driving growth and trust, eliminating costs and reducing risks. The company’s sustainable living brands delivered 78% of total growth and 75% of turnover in 2019.

Since 2010 we have been taking action through the Unilever Sustainable Living Plan to help more than a billion people improve their health and well-being, halve our environmental footprint and enhance the livelihoods of millions of people as we grow our business. We have made significant progress and continue to expand our ambition – in 2019 committing to ensure 100% of our plastic packaging is fully reusable, recyclable or compostable by 2025. While there is still more to do, we are proud to have been recognised in 2019 as sector leader in the Dow Jones Sustainability Index and in 2020 – for the tenth-consecutive year – as the top ranked company in the GlobeScan/SustainAbility Sustainability Leaders survey.

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First immunotherapy to be approved for a gastroesophageal cancer in the European Union

Approval based on Phase 3 ATTRACTION-3 trial showing statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy.

The EC’s decision is based on results from the Phase 3 ATTRACTION-3 trial, a study sponsored by Ono Pharmaceutical Co., Ltd. of Japan, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in patients who received Opdivo versus chemotherapy. The safety profile for Opdivo was favorable compared with chemotherapy and consistent with previously reported studies of Opdivo in other solid tumors.

“Today’s approval marks a critically important milestone for those living with esophageal squamous cell carcinoma, as this is the first time an immunotherapy treatment option has been approved in the European Union for this patient population,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “We are proud of our work in advancing treatment options for people living with upper gastrointestinal cancers, and we look forward to working with European stakeholders to bring Opdivo to more eligible patients who may benefit.”

In addition to this approval in the EU, Opdivo has been approved in five countries, including the United States and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic ESCC. Bristol Myers Squibb thanks the patients and investigators involved in the ATTRACTION-3 clinical trial for their important contributions.

ATTRACTION-3 Efficacy and Safety Results

In the Phase 3 ATTRACTION-3 trial, which had a primary endpoint of OS:

• Opdivo reduced risk of death by 23%, compared to chemotherapy alone [Hazard Ratio (HR) 0.77; 95% Confidence Interval (CI): 0.62 to 0.96; p=0.019].
• Median OS with Opdivo was 10.9 months (95% CI: 9.2 to 13.3) compared to 8.4 months (95% CI: 7.2 to 9.9) with chemotherapy alone, demonstrating a 2.5-month improvement.
• The Opdivo arm showed 12- and 18-month OS rates of 47% (95% CI: 40 to 54) and 31% (95% CI: 24 to 37), respectively, versus 34% (95% CI: 28 to 41) and 21% (95% CI: 15 to 27) among patients in the chemotherapy arm. Survival benefit with Opdivo was observed regardless of tumor PD-L1 expression levels.
• Objective response rates (ORR) between the Opdivo and chemotherapy arms were comparable at 19% (95% CI: 14 to 26) and 22% (95% CI: 15 to 29), respectively.
• Median duration of response (DoR) for patients was substantially increased in the Opdivo arm at 6.9 months (95% CI: 5.4 to 11.1) versus 3.9 months (95% CI: 2.8 to 4.2) in the chemotherapy arm.
• An exploratory analysis of patient-reported outcomes showed significant overall improvement in quality of life with Opdivo versus chemotherapy. Fewer treatment-related adverse events (TRAEs) were reported with Opdivo versus chemotherapy, with a rate of 66% for any grade TRAEs in patients receiving Opdivo compared to 95% for those patients receiving chemotherapy. Patients in the Opdivo arm also experienced a lower incidence of Grade 3 or 4 TRAEs compared to those in the chemotherapy arm (18% versus 63%), and the percentage of patients experiencing TRAEs leading to discontinuation was the same in both arms (9%).

About ATTRACTION-3

ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) is a Phase 3, multi-center, randomized, open-label global study, evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for patients with esophageal cancer refractory or intolerant to first-line combination therapy with fluoropyrimidine- and platinum-based drugs. Patient enrollment occurred predominantly in Asia, with the remainder in the United States and Europe. Patients were treated until disease progression or unacceptable toxicity. The primary endpoint of the trial was overall survival (OS). Secondary endpoints included investigator-assessed objective response rate (ORR), progression-free survival (PFS), disease control rate, duration of response and safety.

About Esophageal Cancer

Esophageal cancer is the seventh most common cancer and the sixth most common cause of death from cancer worldwide. The five-year relative survival rate is 10% or less for patients diagnosed with metastatic disease. Each year, 53,000 new cases of esophageal cancer are diagnosed in Europe. The two most common types of esophageal cancer are adenocarcinoma and squamous cell carcinoma, the latter accounting for approximately 60% of all esophageal cancer cases diagnosed in Europe. The majority of cases are diagnosed in the advanced setting and impact a patient’s daily life, including their ability to eat and drink.

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

Bristol Myers Squibb is inspired by a single vision — transforming people’s 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 scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at 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. Because 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 October 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.

INDICATIONS

OPDIVO^® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

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 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) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. 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 first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

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

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

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 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 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. This indication is approved under accelerated approval based on tumor 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), 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) is indicated for the treatment of 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), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of 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 adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

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

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 HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 10% (5/49) of patients. 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.

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%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%) and Grade 2 (5%).

Immune-Mediated Hepatitis

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%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%) and Grade 2 (2.5%).

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 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 (4.5%) and Grade 2 (2.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3, (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%), and Grade 2 (4.5%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, Grade 2-5 immune-mediated endocrinopathies occurred in 4% (21/511) of patients. Severe to life-threatening (Grade 3-4) endocrinopathies occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate (Grade 2) endocrinopathy occurred in 12 patients (2.3%), including hypothyroidism, adrenal insufficiency, hypopituitarism, hyperthyroidism and Cushing’s syndrome.

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies.

Contacts

Bristol Myers Squibb

Media Inquiries:

Media@BMS.com

Investors:

Tim Power

609-252-7509

timothy.power@bms.com

Read full story here

SOMERSET, N.J.–(BUSINESS WIRE)–Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that it has appointed Dr. Li Zhu to Legend Biotech’s Board of Directors. Dr. Zhu will serve as a Class III director.

In addition, Dr. Fangliang Zhang tendered his resignation from the Board of Directors of Legend Biotech and its committees, effective as of November 22, 2020. As announced on September 21, 2020, Dr. Zhang had been under residential surveillance in connection with an investigation by the Customs Anti-Smuggling Department of Zhenjiang (the “Authority”) in the People’s Republic of China, and he has now been formally placed under arrest. While no charges have been filed against him, Dr. Zhang decided that to avoid unnecessary distraction to Legend Biotech, his resignation would be in the interests of Legend Biotech and its shareholders. To date, no charges have been filed against Legend Biotech or any of its officers or directors, and Legend Biotech does not believe that it is a subject of the Authority’s investigation.

“The Board of Legend Biotech would like to take this opportunity to express its sincere gratitude and appreciation to Dr. Zhang for his valuable contribution to the company during his tenure of service,” said Sally Wang, Chairwoman of Legend Biotech. “We are excited to welcome Dr. Zhu to our Board of Directors. The addition of Dr. Zhu complements our Board’s skills and experiences, and we are confident he will provide valuable support to Legend Biotech’s strategic development and objective to bring innovative and impactful cell therapies toward potential registration and commercialization.”

Dr. Zhu served as the vice president of strategy of GenScript Biotech Corporation (“GenScript”) from March 2010 to February 2017, served as the chief strategy officer of GenScript from February 2017 to July 2019, and has served as a consultant for GenScript since July 2019. Upon his appointment as executive director of GenScript on November 22, 2020, he resumed his role as the chief strategy officer of GenScript. Before joining GenScript, Dr. Zhu worked at California-based Clontech Laboratories, Inc. as a director of molecular biology from January 1990 to March 2000. Dr. Zhu founded Genetastix Corporation, Inc., a biotech company focused on yeast-based antibody discovery, and served as president and chief executive officer from May 2000 to December 2005. Dr. Zhu then worked at biotech companies in China, serving as vice president of research at Cathay Biotech, Inc. from July 2006 to December 2008, and as vice president of HUYA Biomedical Technology (Shanghai) Co., Limited from January 2009 to December 2009. Dr. Zhu obtained a Bachelor of Science of Biology degree from the East China Normal University in June 1982 and a Doctor of Philosophy in molecular biology and immunology from Stanford University in July 1989.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.

We are engaged in a strategic collaboration with Janssen Biotech, Inc. to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to statements relating to the investigation of the Customs Anti-Smuggling Department of the People’s Republic of China, Legend Biotech’s strategic development and objectives, and the potential contributions of its new board member. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

Contacts

For Investor Relations inquiries:
Jessie Yeung, Head of Corporate Finance and Investor Relations, Legend Biotech USA Inc. jessie.yeung@legendbiotech.com or investor@legendbiotech.com
Surabhi Verma, Manager of Investor Relations and Corporate Communications, Legend Biotech USA Inc.

surabhi.verma@legendbiotech.com or media@legendbiotech.com

• Prescription Drug User Fee Act target action date of May 21, 2021

LAUSANNE, Switzerland–(BUSINESS WIRE)–ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021.

“The FDA’s acceptance of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021,” said Chris Martin, Chief Executive Officer of ADC Therapeutics. “We look forward to working with the FDA during its review of our BLA submission for Lonca. Our organization remains focused on robust planning for a successful launch next year.”

The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy. In June 2020, the Company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association. As of the April 6^th cutoff date, Lonca demonstrated an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1% (35/145 patients). The tolerability profile was manageable with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (16.6%) and anaemia (10.3%).

Data from subgroup analyses of LOTIS 2 will be presented in a poster (abstract #1183) at the upcoming 62^nd American Society for Hematology (ASH) Annual Meeting on Saturday, December 5, 2020.

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

Lonca, the Company’s lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. Lonca is also being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

About ADC Therapeutics

ADC Therapeutics SA (NYSE: ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

Camidanlumab tesirine (Cami, formerly ADCT-301), the Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86.5% ORR in HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable patient population, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Contacts

Investors
Amanda Hamilton

ADC Therapeutics

amanda.hamilton@adctherapeutics.com
Tel.: +1 917 288 7023

EU Media
Alexandre Müller

Dynamics Group

amu@dynamicsgroup.ch
Tel: +41 (0) 43 268 3231

USA Media
Annie Starr

6 Degrees

astarr@6degreespr.com
Tel.: +1 973-415-8838

Initiative will train 250 new clinical investigators and work within communities to build capacity to serve underrepresented patient populations

PRINCETON, N.J.–(BUSINESS WIRE)–The Bristol Myers Squibb Foundation and National Medical Fellowships today announced that they have entered into a partnership aimed at improving diversity in clinical trials. Leveraging $100 million of the previously announced commitment from Bristol Myers Squibb and the Bristol Myers Squibb Foundation to diversity and inclusion, the partnership will develop a program to extend the reach of clinical trials into underserved patient populations in urban and rural U.S. communities. This program will train and develop 250 new clinical investigators who are racially and ethnically diverse or who have a demonstrated commitment to increasing diversity in clinical trials, and it will expose 250 promising, underrepresented minority medical students across the country to clinical research career pathways. Additionally, the program will assist program investigators in building capacity and standing up new clinical trials sites in communities with diverse and heavily burdened patient populations.

The need for diversity in clinical trials

“Clinical research is necessary to generate evidence demonstrating the efficacy and safety of new treatments,” said Robert Winn, M.D., Director, Massey Cancer Center, Virginia Commonwealth University, who is serving as chair of the national advisory committee of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program. “While the patient response to medical therapies may differ across racial and ethnic subgroups, clinical trials often fail to represent the demographic diversity of the populations that these products aim to serve. I am proud to serve as an advisor to this program, which will support improvements toward diverse representation in clinical research and promote health equity.”

In fact, aggregated data on the racial and ethnic participation in clinical trials published by the FDA show that in general 80% of patients taking part in clinical trials are white. Black Americans represent 13%¹ of the US population but only reflect about 7%² of participants in clinical trials.

John Damonti, president of the Bristol Myers Squibb Foundation added, “Science demonstrates that we must diversify clinical trials in order to improve health outcomes and advance health equity. We are pleased to partner with National Medical Fellowships so that this effort will benefit from their decades of experience and unmatched expertise. Together, we will tap the often overlooked but powerful resource of racially and ethnically diverse physicians or other physicians who have a demonstrated commitment to increasing diversity in clinical trials, working in academic medical centers, community-based practices and Federally Qualified Health Centers. These physicians are established in their communities, and no one is in a better position to build trusting relationships with patients than they are.”

“Diversity has a role to play in the entire lifecycle of therapeutic development, from the trial design and community engagement, to therapeutic efficacy and adoption,” said Sandra Nichols, M.D., Chairperson, National Medical Fellowships Board of Directors. “National Medical Fellowships has a vision to promote equity of access to quality healthcare for all groups in American society. Advancing diversity in clinical trials is a critically important component of this effort, and our partnership with the Bristol Myers Squibb Foundation is consistent with our mission.”

About the program

The goal of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program is to increase diversity of patients enrolled in clinical trials, and ultimately enhance the development of therapeutics for all populations. The program will collaborate with communities to facilitate an approach to clinical and translational research that is community-informed, designed and conducted. It will provide the sponsorship, support and tools that emerging investigators need to conduct clinical trials that will yield the development of new treatments that are effective in all populations.

How to apply

Applications will open in January 2021. Eligible candidates will hold the degree of MD, MD/PhD, DO or DO/PhD and have an interest in clinical research in the areas of cancer (hematology and oncology), cardiovascular disease and immunologic disorders. In addition, they will reflect the NIH definition of Early Stage Investigator and the NIH definition of underrepresented populations in the U.S. Biomedical, Clinical Behavioral and Social Sciences Research Enterprise, or have a demonstrated commitment to increasing diversity in clinical trials. To learn more about eligibility and program details, please email DCTCDPinfo@nmfonline.org.

About the Bristol Myers Squibb Foundation

The Bristol Myers Squibb Foundation is committed to improving the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and addressing unmet medical need.

National Medical Fellowships

Seeking to empower and support aspiring physicians and health professionals underrepresented in medicine to contribute to the health of our nation, National Medical Fellowships’ mission is to provide scholarships and support for underrepresented minority students in medicine and the health professions.

Founded in 1946, NMF was one of America’s first diversity organizations. Today, as we come together to celebrate our diversity with joy and new purpose, NMF remains the only national organization solely dedicated to providing scholarships to medical and health professions students in all groups underrepresented in healthcare.

NMF is supported by a national network of Alumni who serve tens of millions of patients annually. Their experience inspires us and gives voice to our mission.

philathropy-news

¹ https://www.census.gov/newsroom/releases/archives/2010_census/cb11-cn125.html
² https://www.fda.gov/media/143592/download

Contacts

BRISTOL MYERS SQUIBB FOUNDATION
MEDIA: media@bms.com

Deucravacitinib, the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases, showed significantly greater ACR 20 responses compared to placebo at 16 weeks and met all key secondary endpoints

Deucravacitinib was well-tolerated with a safety profile consistent with prior studies

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #ACR20—Bristol Myers Squibb (NYSE:BMY) today announced results from an ongoing Phase 2 study evaluating the safety and efficacy of deucravacitinib (BMS-986165) 6 mg or 12 mg once daily, compared with placebo in adults with active psoriatic arthritis. The study met the primary endpoint of at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at Week 16. Patients treated with deucravacitinib 6 mg (n=70) or 12 mg (n=67) demonstrated significantly greater ACR 20 responses versus placebo (n=66) at Week 16 (52.9% and 62.7% versus 31.8%, respectively) (p=0.0134 and p=0.0004, respectively). Treatment with deucravacitinib also led to significant improvements on key secondary endpoints relevant for patients, including improvement from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and change from baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 Item (SF-36) Questionnaire.

These results (Abstract #L03) will be presented today as part of the Late-Breaking Posters Session from 9:00-11:00 a.m. EST at the American College of Rheumatology (ACR) Convergence 2020.

“The positive data from this Phase 2 study evaluating the safety and efficacy of deucravacitinib support the ongoing evaluation of this novel oral therapy for people living with the debilitating effects of psoriatic arthritis,” said lead study investigator, Philip Mease, M.D., director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine, Seattle. “Many patients with psoriatic arthritis are not adequately treated, reinforcing the need for safe and effective oral treatment options that may help control the range of symptoms experienced as a result of this disease.”

At Week 16, all key secondary endpoints were achieved, with significant improvements observed in additional secondary endpoints evaluated in the trial. Findings include:

• Improvement from baseline in the HAQ-DI for deucravacitinib 6 mg and 12 mg (-0.37, -0.39) compared to placebo (-0.11) (p=0.002 and p=0.0008, respectively).
• Change from baseline in the PCS Score of the SF-36 Questionnaire at Week 16, which was 5.6 and 5.8 for deucravacitinib 6 mg and 12 mg, respectively, versus 2.3 for placebo (p=0.0062 and p=0.0042, respectively).
• Significantly greater improvements in ACR 50 response for patients treated with deucravacitinib 6 mg or 12 mg (24.3% and 32.8%, respectively) compared to placebo (10.6%) (p=0.0326 and p=0.0016, respectively).
• Additionally, a significantly greater proportion of patients treated with deucravacitinib 6 mg or 12 mg achieved the following secondary endpoints compared to placebo:
  • HAQ-DI response, defined as achievement of HAQ-DI minimal clinically important difference 0.35 (p=0.0019 and p=0.0015, respectively).
  • Enthesitis resolution (enthesitis occurs when the connective tissue between tendons or ligaments and bone becomes inflamed; measured by the Leeds Index) (p=0.0138 and p=0.0393, respectively).
  • Minimal disease activity (defined as meeting key disease criteria related to joints, skin lesions, pain, global disease activity and health assessment questionnaire scores) (p=0.0119 and p=0.0068, respectively).

In this trial, deucravacitinib was well-tolerated and the safety profile was similar to that observed in the previously reported Phase 2 psoriasis trial. In the study, there were no serious adverse events reported in deucravacitinib-treated patients. The most common treatment-emergent adverse events for patients who received deucravacitinib 6 mg or 12 mg versus placebo, respectively, were nasopharyngitis (5.7%, 17.9%, 7.6%), rash (4.3%, 6.0%, 0%) and headache (7.1%, 1.5%, 4.5%).

“These data, along with the recent positive Phase 3 data evaluating deucravacitinib in patients with moderate to severe plaque psoriasis, support our continued study of deucravacitinib and bring us one step closer to further advancing care for people living with psoriatic disease,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “As the first and only novel, oral, selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases, deucravacitinib represents Bristol Myers Squibb’s deep scientific commitment to investigating novel targets that may lead to the development of innovative treatments for immune-mediated diseases.”

About the Phase 2 Deucravacitinib Psoriatic Arthritis Trial

The study is an ongoing, one-year, randomized, double-blind, placebo-controlled (initial 16 weeks), multicenter, Phase 2 trial. Eligible patients had a psoriatic arthritis diagnosis for at least 6 months, met Classification for Psoriatic Arthritis (CASPAR) criteria and had active disease (at least 3 tender and at least 3 swollen joints), C reactive protein ≥3 mg/L (ULN, 5 mg/L) and at least 1 psoriatic lesion (≥2 cm). Patients had failed or were intolerant to at least 1 nonsteroidal anti-inflammatory drug, corticosteroid and/or conventional synthetic disease-modifying antirheumatic drug (csDMARD). Patients had failed up to 1 TNF inhibitor (≤30%). Patients were randomized 1:1:1 to deucravacitinib 6 mg once daily (QD), 12 mg QD, or placebo.

The primary endpoint was ACR 20 response at Week 16. Key secondary endpoints included improvement from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Physical Component Score (SF-36 PCS). Additional endpoints included the proportion of patients achieving ACR 50/70, HAQ-DI response (≥0.35 improvement from baseline), minimal disease activity, enthesitis resolution (Leeds Index) and adverse events.

Of 203 patients randomized, 180 (89.0%) completed 16 weeks of treatment. The mean age was 49.8 years, median psoriatic arthritis duration was 4.5 years, 65.0% of patients were using csDMARDs at baseline and 15.8% had failed or were intolerant to TNF inhibitors. More information can be found on www.clinicaltrials.gov (NCT03881059).

About Psoriatic Arthritis

Psoriatic arthritis is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (which occurs when the connective tissue between tendons or ligaments and bone becomes inflamed), dactylitis (inflammation of the fingers and toes) and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis will develop psoriatic arthritis. In addition to the loss of physical function, pain and fatigue caused by psoriatic arthritis, the disease can significantly impact the mental and emotional well-being of patients. Patients with psoriatic arthritis are also at increased risk of developing serious comorbidities, including cardiovascular disease, metabolic syndrome and depression, as well as extraarticular manifestations of disease, such as inflammatory bowel disease.

About Deucravacitinib

Deucravacitinib (BMS-986165) is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Deucravacitinib’s selectivity is driven by a unique mechanism of action that is distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type I IFN, which are naturally occurring cytokines involved in inflammatory and immune responses.

Deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Deucravacitinib is not approved for any use in any country.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that deucravacitinib (BMS-986165) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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