Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) + Chemotherapy for Patients with HER2 Negative, Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma whose Tumors Express PD-L1 with CPS ? 5

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ? 5.

The EC's decision is based on results from the Phase 3 CheckMate -649 trial, in which first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) was compared with chemotherapy alone. Results from the trial showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic gastric cancer (GC), GEJ cancer (GEJC) or EAC whose tumors express PD-L1 with a CPS ? 5 (the primary endpoints of the study). The statistically significant OS benefit shown with Opdivo plus chemotherapy was also observed in PD-L1 positive patients with CPS ? 1 and in the all-randomized population. The safety profile observed for Opdivo plus chemotherapy in the CheckMate -649 trial was consistent with the known safety profiles of the individual treatments.

'This approval marks a great achievement for many patients with gastric, gastroesophageal junction and esophageal adenocarcinomas, who now have a new treatment option that has demonstrated superior overall survival compared to the long-standing standard of care,' said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. 'With limited advances for HER2-negative gastric cancers made in the past ten years, we are especially pleased to move the field forward and introduce this Opdivo-based combination for patients in the European Union.'

The EC approval allows for the use of Opdivo in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC), whose tumors express PD-L1 with a combined positive score (CPS) ? 5 in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

CheckMate -649 Efficacy and Safety Results in Patients with PD-L1 CPS ? 5

Results from CheckMate -649 include:

OS (minimum follow-up of 19.4 months): Median OS was 14.4 months in patients receiving Opdivoplus chemotherapy (95% Confidence Interval [CI]: 13.1 to 16.3) compared to 11.1 months (95% CI: 10.0 to 12.1) in patients receiving chemotherapy alone (Hazard Ratio [HR] 0.69; 95% CI: 0.60 to 0.81).

PFS (minimum follow-up of 19.4 months): Median PFS was 8.31 months in patients receiving Opdivoplus chemotherapy (95% CI: 7.03 to 9.26) vs. 6.05 months (95% CI: 5.55 to 6.90) in patients receiving chemotherapy alone (HR = 0.68; 95% CI: 0.59 to 0.79).

Safety: The most frequent adverse reactions were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), musculoskeletal pain (20%), pyrexia (19%), rash (18%), stomatitis (17%), palmar-plantar erythrodysaesthesia syndrome (13%), cough (13%), oedema (including peripheral oedema) (12%), headache (11%), and upper respiratory tract infection (10%).

About CheckMate -649

CheckMate -649 is a Phase 3 randomized, multi-center, open-label study evaluating Opdivo plus chemotherapy or the Opdivo plus Yervoy combination compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. Patients in the Opdivo plus chemotherapy arm received Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks or Opdivo 240 mg plus 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) every two weeks. Patients in the Opdivo plus Yervoy arm received Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks for four cycles followed by Opdivo 240 mg every two weeks. Patients in the chemotherapy arm received FOLFOX or CapeOX every two or three weeks, respectively. All patients continued treatment for two years or until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoints of the trial are overall survival (OS) in PD-L1 positive patients with a combined positive score (CPS) ? 5 treated with Opdivo plus chemotherapy and PFS, as assessed by Blinded Independent Central Review (BICR), in CPS ? 5 patients treated with Opdivo plus chemotherapy compared to chemotherapy alone. Secondary endpoints include OS in CPS ? 1 and all randomized patients treated with Opdivo plus chemotherapy as well as OS and time to symptom deterioration (TTSD) in patients treated with Opdivo plus Yervoy compared to chemotherapy alone.

About Gastric Cancer

Gastric cancer, also known as stomach cancer, is the fifth most common cancer and the fourth leading cause of cancer death worldwide, with over 1,000,000 new cases and approximately 770,000 deaths in 2020. There are several cancers that can be classified as gastric cancer, including certain types of cancers that form in the gastroesophageal junction, the area of the digestive tract where the esophagus and stomach connect. While GEJ cancer has a lower prevalence than distal gastric cancer, it continues to rise.

About Esophageal Cancer

Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal adenocarcinoma occurring in North America (65%) and Europe (~40%).

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.

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.

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 the outcome of pricing and reimbursement negotiations in individual countries in Europe may delay or limit the commercial potential of Opdivo for the additional indications described in this release, any marketing approvals, if granted, may have significant limitation on their use, that continued approval of such product candidate for such additional indications described in this release may be contingent upon verification and description of clinical benefit in confirmatory trials, and whether such product candidate for such additional indications 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, 2020, 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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