Bristol Myers Squibb to Highlight Diversified Approaches and Commitment to Improving Outcomes for Patients with Cancer and Serious Blood Disorders at ASCO, EHA and ICML 2023

First disclosure from Phase 3 COMMANDS study, selected for both ASCO’s official press program and EHA’s plenary session, highlights potential of Reblozyl (luspatercept-aamt) as first-line treatment of anemia in very low- to intermediate-risk myelodysplastic syndromes

First presentation of results from primary analysis of TRANSCEND CLL 004 demonstrates benefit of Breyanzi (lisocabtagene maraleucel) in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

New TRIDENT-1 data reinforce potential of precision medicine repotrectinib in patients with locally advanced or metastatic ROS1 fusion-positive non-small cell lung cancer (NSCLC), including those with central nervous system metastases

Four-year data in NSCLC from CheckMate -9LA demonstrate durable long-term survival benefit for Opdivo (nivolumab) + Yervoy (ipilimumab) + platinum-based chemotherapy and three-year data from CheckMate -816 continue to demonstrate long-term clinical benefits of Opdivo + chemotherapy in patients with earlier stages of NSCLC

Bristol Myers Squibb to Host Virtual Investor Event on Tuesday, June 6, 2023, to Discuss ASCO Highlights

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #17ICML—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, the European Hematology Association (EHA) Congress, and the International Conference on Malignant Lymphoma (ICML), underscoring the company’s momentum towards delivering treatment options with the hope to transform clinical outcomes for patients. Data from more than 160 company-sponsored studies, investigator-sponsored studies and collaborations evaluating compounds spanning 20 cancer types and serious blood disorders will be featured across the three meetings, including the COMMANDS study, which has been selected for the official ASCO press program (Abstract #7003) and EHA plenary session (Abstract #S102).

“We look forward to sharing our research during ASCO, EHA and ICML, demonstrating the diversity of our assets, cutting-edge pipeline, and science-driven strategy focused on shaping the next generation of cancer care,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “The breadth of data and results illustrate how we are leveraging novel technologies to develop therapies that disrupt the course of disease for patients with solid tumors, blood cancers, and blood disorders. Positive study outcomes are critical, and so is ensuring those results represent and can benefit a diverse population of patients. Our health equity commitments are enabling inclusive innovation, better science and greater reach of our medicines to the patients who need them most.”

Key data being presented by Bristol Myers Squibb at ASCO, EHA and ICML 2023 include:

Hematology

• First disclosure of data from the Phase 3 COMMANDS study of Reblozyl (luspatercept-aamt) versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), demonstrated highly statistically significant and clinically meaningful improvement in patients with anemia associated with very low- to intermediate-risk myelodysplastic syndromes, who require red blood cell (RBC) transfusions and are ESA-naïve. (ASCO/EHA)
• Preliminary results from the dose-escalation and expansion components of the Phase 1 CC-93269-MM-001 study demonstrate subcutaneous administration of bispecific T-cell engager alnuctamab exhibited promising dose-dependent anti-tumor activity in heavily pretreated multiple myeloma, with a high proportion of responders achieving minimal residual disease negativity. (EHA)
• Results from the dose-escalation components of a Phase 1/2 study evaluating BET inhibitor BMS-986158 as monotherapy and in combination with ruxolitinib or Inrebic (fedratinib), show generally manageable safety and robust spleen volume reduction in patients with intermediate- or high-risk myelofibrosis. (EHA)
• First disclosure of clinical data from a Phase 1b study evaluating golcadomide (CC-99282), a novel CELMoD^TM agent, in combination with R-CHOP in patients with previously untreated aggressive B-cell lymphoma will be presented. (ICML)
• Results from a dose-expansion cohort of the Phase 1/2 CC-92480-MM-001 study, evaluating novel CELMoD agent, mezigdomide, with dexamethasone in patients with relapsed/refractory multiple myeloma, showed the combination’s safety profile and promising efficacy in patients with triple-class refractory multiple myeloma. (EHA)

Cell Therapy

• First disclosure of data from the primary analysis of the TRANSCEND CLL 004 study of Breyanzi (lisocabtagene maraleucel) demonstrated deep and durable responses and a manageable safety profile, with no new safety signals, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. (ASCO)
• Multiple analyses from the KarMMa-3 study showed improved health-related quality of life (HRQOL) and patient-reported outcomes, in addition to lower risk of disease progression, with Abecma (idecabtagene vicleucel), regardless of baseline high-risk disease or number of prior lines of therapy, in patients with triple-class exposed relapsed and refractory multiple myeloma. (ASCO/EHA)
• Interim results from Phase 1 study of GPRC5D CAR T (BMS-986393/CC-95266) demonstrated durable responses with an overall generally manageable safety profile, including in patients with prior BCMA-directed therapy. (EHA)

Solid Tumor

• Results from the registrational TRIDENT-1 trial showed durable clinical activity with repotrectinib in ROS1 tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with locally advanced or metastatic ROS1-positive NSCLC with or without baseline central nervous system metastases, including robust intracranial responses. (ASCO)
• Four-year data from the Phase 3 CheckMate -9LA trial reinforce durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for patients with metastatic NSCLC, including subgroups with higher unmet needs. (ASCO)
• Three-year results demonstrated long-term clinical benefit of neoadjuvant Opdivo with chemotherapy in patients with resectable NSCLC who received definitive surgery in the Phase 3 CheckMate -816 trial. (ASCO)
• Biomarker analyses from the Phase 3 CheckMate -76K trial support a potential clinical benefit of Opdivo for the adjuvant treatment of patients with stage IIB/C melanoma, across all biomarker sub-groups. (ASCO)
• Three-year data from the Phase 3 CheckMate -649 trial evaluating Opdivo plus chemotherapy continue to demonstrate durable long-term survival and HRQOL benefits in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (ASCO)
• Two-year data from the Phase 2/3 RELATIVITY-047 trial showed consistent benefit with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in patients with previously untreated metastatic or unresectable melanoma. (ASCO)

Please see below for Important Safety Information and full Prescribing Information for Reblozyl, Opdualag, Opdivo, and Opdivo+Yervoy.

Please see below for Important Safety Information and full Prescribing Information, including Boxed Warnings, for Abecma, Breyanzi and Inrebic.

Investor Event

Bristol Myers Squibb will host a virtual Investor Event on Tuesday, June 6, 2023, from 7:00-8:00 a.m. CT/8:00-9:00 a.m. ET to discuss data presented at ASCO. Company executives will provide an overview of data presented and address questions from investors and analysts.

Investors and the general public are invited to listen to a live webcast of the event at http://investor.bms.com. An archived edition of the session will be available later that day.

Summary of Presentations

Select Bristol Myers Squibb studies at the 2023 ASCO Annual Meeting include:

All abstracts except late-breaking abstracts will be available on the ASCO website at 5:00 PM EDT on Thursday, May 25. All late-breaking abstracts will be available on the ASCO website at 8:00 AM EDT on the day of the scientific session for the abstract presentation.

Select Bristol Myers Squibb studies at the 2023 EHA Congress include:

Contacts

Bristol Myers Squibb


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