- Bristol Myers Squibb (NYSE:BMY) announces results for the co-primary endpoint for CheckMate-915, a randomized Phase 3 study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo for patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma.
- The addition of Yervoy to Opdivo did not result in a statistically significant improvement in recurrence-free survival (RFS) in the all-comer (intent-to-treat) population.
- The safety profiles for Opdivo monotherapy and the combination of Opdivo plus Yervoy were consistent with previously reported studies at this dose and schedule, with no new safety signals observed.
- The study was designed to determine if dual immunotherapy has the potential to bring additional benefits to patients in this setting.
- In November 2019, BMY announced that a statistically significant benefit was not reached for the co-primary endpoint of RFS in patients whose tumors expressed PD-L1 <1%.
- https://seekingalpha.com/news/3619670-bristol-myers-opdivo-yervoy-again-shows-underwhelming-response-in-melanoma-study
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Monday, October 5, 2020
Bristol Myers Opdivo + Yervoy again shows underwhelming response in melanoma study
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