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Bristol-Myers Squibb Company (BMY) is a global biopharmaceutical leader developing innovative therapies in oncology, cardiovascular diseases, and immunology. This dedicated news hub provides investors and healthcare professionals with direct access to BMY's latest developments, including FDA approvals, clinical trial results, and strategic partnerships.
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Bristol Myers Squibb (NYSE: BMY) announced positive three-year follow-up results from the Phase 3 CheckMate -9LA trial for metastatic non-small cell lung cancer (mNSCLC). The trial demonstrated a significant improvement in overall survival (OS) with Opdivo and Yervoy, achieving a 27% survival rate compared to 19% for chemotherapy alone. Notably, results were favorable for patients with PD-L1 expression <1%. The safety profile remains consistent with previous findings. These findings underscore the potential of dual immunotherapy in addressing high unmet needs in mNSCLC.
Bristol Myers Squibb (BMY) reported five-year results from the Phase 3 CheckMate -227 trial, showing that the combination of Opdivo and Yervoy nearly doubled the overall survival rate at five years in patients with metastatic non-small cell lung cancer (mNSCLC) compared to chemotherapy. The five-year survival rate for patients with PD-L1 expression ≥1% was 24% for the immunotherapy combo, versus 14% for chemotherapy. In patients with PD-L1 expression <1%, survival rates were 19% vs. 7%. These results highlight the long-term efficacy and potential of Opdivo and Yervoy as first-line treatments.
Bristol Myers Squibb (NYSE: BMY) announced the withdrawal of its supplemental biologics license application for Reblozyl (luspatercept-aamt) aimed at treating anemia in adults with non-transfusion dependent beta thalassemia. The decision comes after the FDA raised concerns regarding the drug's benefit-risk profile based on data from the Phase 2 BEYOND trial. Despite this setback, the company continues to advance Reblozyl through a broad clinical development program.
Bristol Myers Squibb (NYSE:BMY) announced an all-cash tender offer to acquire Turning Point Therapeutics (NASDAQ:TPTX) for $76.00 per share, valuing the deal at approximately $4.1 billion. The acquisition includes repotrectinib, a promising next-generation ROS1/NTRK inhibitor, expected to launch in 2023 and enhance BMY's oncology portfolio. The deal is anticipated to be accretive to non-GAAP earnings per share starting in 2025. Both companies' boards unanimously approved the transaction, expected to close in Q3 2022, subject to customary conditions.
Bristol Myers Squibb (NYSE: BMY) announced topline results from the Phase 3 ACTIV-1 Immune Modulators study, sponsored by the National Institutes of Health. The trial evaluated Orencia (abatacept) for hospitalized COVID-19 patients. Results showed a statistically non-significant improvement in recovery time, but a notable reduction in the risk of death (11% vs. 15% for placebo), translating to 37.4% lower odds of mortality. Participants also experienced 34.2% better odds of clinical improvement. The drug's safety profile was consistent, with no new safety signals reported.
Immatics and Bristol Myers Squibb have expanded their strategic collaboration to develop allogeneic TCR-T and CAR-T therapies. Immatics will receive an upfront payment of $60 million, with additional milestone payments of up to $700 million for each program, along with tiered royalties. The partnership will leverage Immatics’ ACTallo® platform and Bristol Myers Squibb’s oncology expertise, focusing on multiple programs. Additionally, an autologous TCR-T target will be added under their existing 2019 agreement, granting Immatics a further $20 million upfront.
Bristol Myers Squibb (NYSE: BMY) announced promising results from the Phase 2 PAISLEY study on deucravacitinib, an oral TYK2 inhibitor for moderate to severe systemic lupus erythematosus (SLE).
The study met its primary endpoint with statistically significant SLE Responder Index-4 (SRI(4)) responses at Week 32: 58.2% for deucravacitinib 3 mg BID, 49.5% for 6 mg BID, compared to 34.4% for placebo.
Secondary endpoints showed clinically meaningful improvements at Week 48.
The safety profile was consistent with earlier studies, supporting advancement to Phase 3 trials.
Bristol Myers Squibb announced FDA approval for Opdivo® (nivolumab) in combination with chemotherapy and Opdivo plus Yervoy® (ipilimumab) for first-line treatment of unresectable advanced esophageal squamous cell carcinoma (ESCC). The approval follows results from the CheckMate -648 trial, which demonstrated improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone. Opdivo-based therapies are now approved for five indications in upper gastroesophageal cancers, offering new treatment options regardless of PD-L1 status.
Bristol Myers Squibb (NYSE: BMY) announced the primary analysis results of the Phase 2 PILOT study for Breyanzi in adults with refractory or relapsed large B-cell lymphoma (LBCL). The treatment achieved an 80% overall response rate, with 54% of patients experiencing complete responses. The median duration of response was 12.1 months, and progression-free survival was at 9 months. Breyanzi demonstrated a manageable safety profile and improved patient-reported outcomes regarding quality of life. A supplemental Biologics License Application for this indication is under Priority Review by the FDA, with a target decision date of June 24, 2022.
Bristol Myers Squibb (NYSE: BMY) will participate in a fireside chat at Bernstein’s 38th Annual Strategic Decisions Conference on June 2, 2022, at 8:00 a.m. ET in New York. Giovanni Caforio, M.D., Board Chair and CEO, along with Samit Hirawat, Chief Medical Officer, will discuss the company’s strategies. The event will be accessible via a live webcast at investor.bms.com, with an archived version available later that day. Bristol Myers Squibb focuses on developing innovative medicines for serious diseases.