Trial setback for B-MS combo
US pharma major Bristol-Myers Squibb (NYSE: BMY) has announced that its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has failed to meet a primary endpoint in the CheckMate -915 Phase III melanoma trial.
This regimen was being compared to Opdivo alone in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma, and failed to reach statistical significance in the co-primary endpoint of recurrence-free survival (RFS) in people whose tumors expressed PD-L1 levels of less than 1%.
The Data Monitoring Committee recommended that the study continue unchanged. The study remains double-blinded and will continue to assess the other co-primary endpoint of RFS in the all-comer population.
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