Bristol Myers Squibb: Phase 3 CheckMate -901 Trial Fails To Meet Primary Endpoint

Bristol Myers Squibb (BMY) said the phase 3 CheckMate -901 trial, comparing Opdivo plus Yervoy to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma, did not meet the primary endpoint of overall survival in patients whose tumor cells express PD-L1 1% at final analysis. An independent Data Monitoring Committee recommended that the trial continue to assess other primary and secondary endpoints, the company stated.

The company noted that the CheckMate -901 primary study and sub-study are ongoing, and
it will report results for these additional components of the study when available.

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