First Phase 3 data from the RELATIVITY-047 trial highlight clinical benefit of LAG-3 blocking antibody relatlimab – the company’s third distinct checkpoint inhibitor – in combination with nivolumab for patients with previously untreated unresectable or metastatic melanoma

First disclosure of results from CheckMate -648 demonstrate Opdivo (nivolumab) plus Yervoy (ipilimumab) and Opdivo plus chemotherapy’s potential to address unmet needs in advanced esophageal squamous cell carcinoma

Long-term data in non-small cell lung cancer and metastatic melanoma continue to show durable survival benefits with Opdivo plus Yervoy-based combinations

New long-term results from KarMMa study of Abecma (idecabtagene vicleucel) and combination data from an early phase study of novel CELMoD agent iberdomide underscore potential of new therapeutic approaches for patients with multiple myeloma

First disclosure of results from Phase 2 BEYOND study evaluating Reblozyl (luspatercept) plus best supportive care demonstrate first-in-class erythroid maturation agent’s potential in adults with non-transfusion-dependent beta (β)-thalassemia

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the presentation of research demonstrating the potential of its medicines to deliver long-term survival, improve outcomes and address areas of high unmet need across cancers and blood disorders at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting, June 4-8, and the European Hematology Association (EHA) 2021 Virtual Congress, June 9-17. Data from more than 75 company-sponsored studies, investigator-sponsored studies and collaborations evaluating compounds across 18 cancer types and blood disorders will be featured at the two meetings, including two abstracts (Abstract #9503 and #LBA4001) selected for the official ASCO press program and one (Abstract #S101) for the EHA presidential symposium.

“Our breadth of data at this year’s ASCO and EHA meetings highlights our diverse pipeline, with numerous approaches aimed at addressing the underlying biology of cancer and blood disorders,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “Through our comprehensive research programs, we’re exploring how immunotherapy combinations may improve survival outcomes for patients with cancer, leading significant advances in cell therapy and erythroid maturation and building on decades of experience in protein degradation to evaluate more potent agents. As we make progress in developing new therapies, we recognize that the needs of patients extend beyond treatment, and we are committed to supporting all aspects of care for all patients. In collaboration with the community, we're working to improve survivorship support and to advance health equity in a time when disparities in care have become an even more pressing issue."

Key data being presented by Bristol Myers Squibb at ASCO and EHA 2021 include:

Solid Tumor

• First presentation of results from the RELATIVITY-047 trial evaluating the LAG-3 blocking antibody relatlimab, the company’s third distinct checkpoint inhibitor and latest innovation, demonstrating clinical benefit for patients in a fixed-dose combination with nivolumab. These data are part of the official ASCO press program on May 14, 2021.
• Longest-ever survival data of the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination from CheckMate -067, demonstrating durable survival benefits over 6.5 years in patients with advanced or metastatic melanoma.
• First disclosure of data from CheckMate -648 showcasing survival benefits of Opdivo plus chemotherapy and Opdivo plus Yervoy, as well as expanded efficacy and safety data from CheckMate -649, with both trials supporting Opdivo’s demonstrated superior first-line efficacy for patients with upper gastrointestinal cancers with high unmet needs. The CheckMate -648 data are part of the official ASCO press program on May 28, 2021.
• Expanded efficacy and safety results from CheckMate -577, the first and only trial to demonstrate superior efficacy of Opdivo monotherapy in the adjuvant setting in patients with esophageal or gastroesophageal junction cancer.
• Two- and four-year data from the CheckMate -9LA and CheckMate -227 trials, reinforcing the role of Opdivo plus Yervoy-based combinations in improving long-term survival for patients with non-small cell lung cancer (NSCLC) in the first-line setting.
• Surgical outcomes data from the CheckMate -816 trial that show the potential of neoadjuvant treatment with Opdivo plus chemotherapy to increase pathological response without negatively impacting surgery for patients with earlier-stage NSCLC.

Hematology

• Longer-term efficacy and safety results presented in collaboration with bluebird bio from the pivotal KarMMa study of Abecma (idecabtagene vicleucel), the first BCMA-directed CAR T cell therapy, in patients with relapsed or refractory multiple myeloma, reinforcing the company’s commitment to advancing cell therapies.
• First data disclosure from Phase 2 BEYOND study of Reblozyl (luspatercept), a first-in-class erythroid maturation agent, plus best supportive care, demonstrating its clinical benefit and potential in patients with non-transfusion-dependent beta (β)-thalassemia. These data are part of the official EHA press briefing and presidential symposium on June 11, 2021.
• New combination data from the Phase 1/2 MM-001 study of iberdomide, highlighting the potential of CELMoD® compounds in patients with relapsed and refractory multiple myeloma and underscoring the company’s foundation in protein degradation research.
• Overall survival and progression-free survival analyses for Inrebic (fedratinib), the first treatment approved in Europe for myelofibrosis in nearly a decade, from the JAKARTA and JAKARTA-2 studies in patients with newly diagnosed and previously treated myelofibrosis.
• New analyses from QUAZAR AML-001 confirming survival benefits of Onureg (azacitidine tablets; CC-486) across different disease subtypes and baseline characteristics in patients with acute myeloid leukemia in the maintenance treatment setting.

Summary of Presentations

Select Bristol Myers Squibb studies at the 2021 ASCO Virtual Annual Meeting include:

Select Bristol Myers Squibb studies at the 2021 EHA Virtual Congress include:

The abstracts above are available on the EHA conference website. All presentations will be available on demand when published on the virtual congress platform on Friday, June 11, at 9:00 AM CEST (3 AM EDT).

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 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.

OPDIVO 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), 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 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 patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of 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 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.

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of 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 (