Bristol-Myers: Opdivo brain cancer study unlikely to meet overall survival endpoint

 

• Bristol-Myers Squibb (NYSE:BMY) provides an update for CheckMate -548, a Phase 3 trial evaluating the addition of Opdivo to the current standard of care (temozolomide and radiation therapy) versus placebo plus the standard of care in patients with newly diagnosed glioblastoma multiforme with O6-methylguanine-DNA methyltransferase promoter methylation following surgical resection of the tumor.
• The company says following a routine review of the study by an independent data monitoring committee, Bristol-Myers was informed that based on the number of events to date, the study will not meet its primary endpoint of overall survival in patients with no baseline corticosteroid use or in the overall randomized population.
• The committee also indicated that no safety concerns observed in patients treated with Opdivo that warranted stopping the study.
• Investigators will be unblinded to the treatment assignments and patients will be counseled on their treatment options, and those currently deriving benefit from Opdivo will be permitted to continue treatment if agreed to with their physician.
• The company says it will complete a full evaluation of the CheckMate -548 data and work with investigators to share the final results.
• Last month, Bristol-Myers won approval for Opdivo from the EU to treat esophageal cancer.
• https://seekingalpha.com/news/3646910-bristol-myers-says-opdivo-brain-cancer-study-unlikely-to-meet-overall-survival-endpoint