Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb has received European Commission approval for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adults with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. The approval follows results from the Phase 3 CheckMate-648 trial, highlighting a median overall survival of 13.70 months for patients treated with Opdivo plus Yervoy, compared to 9.07 months with chemotherapy. This treatment is now available in the EU, Iceland, Liechtenstein, and Norway.

Bristol Myers Squibb announced that the European Commission approved Opdivo (nivolumab) for adjuvant treatment of adults with muscle-invasive urothelial carcinoma, marking it as the first immunotherapy option approved in this setting in the EU. The approval is based on Phase 3 CheckMate -274 trial results, showing a 47% reduction in the risk of disease recurrence or death for patients with PD-L1 expression ≥1%, compared to placebo. Opdivo has now received EU approvals for three cancer types, enhancing its position in cancer treatment.

Bristol Myers Squibb (NYSE: BMY) announced favorable interim results from the EXPLORER-LTE cohort of the MAVA-LTE study, revealing sustained improvements in cardiac measures at 48 and 84 weeks for patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Key findings include a decrease in left ventricular outflow tract (LVOT) gradients and NYHA Class improvements in 67.5% of patients. The safety profile remained stable with no new adverse signals. The company anticipates FDA feedback on its New Drug Application by the end of the month.

Bristol Myers Squibb (NYSE: BMY) announced positive results from the Phase 3 VALOR-HCM study of mavacamten, a first-in-class cardiac myosin inhibitor. The study met all primary and secondary endpoints, demonstrating significant improvements in patients with symptomatic obstructive hypertrophic cardiomyopathy after 16 weeks. Notably, 82% of patients treated with mavacamten did not require septal reduction therapy, compared to only 23% in the placebo group. Safety data showed no new signals, validating mavacamten's efficacy as a potential treatment option.

Bristol Myers Squibb has announced the European Medicines Agency's validation of its application for Opdivo in combination with chemotherapy for neoadjuvant treatment of resectable stage IB to IIIA non-small cell lung cancer (NSCLC). This regimen aims to be the first immunotherapy-based option before surgery in the EU, based on results from the CheckMate-816 trial, which showed significant improvements in event-free survival and pathologic complete response. Opdivo's safety profile remains consistent with previous studies.

Bristol Myers Squibb (NYSE: BMY) announced an extension of the FDA review for the supplemental biologics license application (sBLA) of Reblozyl (luspatercept-aamt), treating anemia in adults with non-transfusion-dependent beta thalassemia, now due by June 27, 2022. This delay is due to a major amendment triggered by a written response to an FDA information request. Reblozyl is already approved for other anemia-related conditions and is being developed in partnership with Merck following its acquisition of Acceleron Pharma.

Bristol Myers Squibb (NYSE: BMY) shared recent findings from its cardiovascular research at the American College of Cardiology’s 71st Annual Scientific Session, held from April 2-4, 2022. The highlights include two late-breaking clinical trials on mavacamten, an investigational treatment for obstructive hypertrophic cardiomyopathy (HCM). These presentations emphasize the company's dedication to addressing cardiovascular diseases and improving patient outcomes. Key studies featured included the Phase 3 VALOR-HCM study and the GUARD-AF study on atrial fibrillation.

Bristol Myers Squibb announced that the FDA has approved Opdualag, a fixed-dose dual immunotherapy combining nivolumab and relatlimab, for patients aged 12 and older with unresectable or metastatic melanoma. This innovative treatment showed a median progression-free survival of 10.1 months, more than doubling the 4.6 months seen with nivolumab alone in the RELATIVITY-047 trial. The safety profile is consistent with nivolumab, with 14.6% of patients experiencing drug-related adverse events leading to discontinuation. This marks a significant expansion of treatment options for melanoma patients.

Bristol Myers Squibb (NYSE: BMY) and Nektar Therapeutics (NASDAQ: NKTR) reported disappointing results from the Phase 3 PIVOT IO-001 study evaluating bempegaldesleukin plus Opdivo versus Opdivo alone in metastatic melanoma. The independent Data Monitoring Committee found no significant benefits in progression-free survival (PFS) or objective response rate (ORR). Consequently, the companies decided to unblind the trial and halt enrollment for the related PIVOT-12 study. The focus will now shift to ongoing studies in renal cell carcinoma and bladder cancer.