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Bristol Myers' Opdivo+Yervoy Fails To Meet Survival Endpoint In Untreated Urothelial Cancer

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  • Bristol Myers Squibb & Co's (NYSE: BMY) Phase 3 CheckMate -901 trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) in urothelial carcinoma did not meet the primary endpoint of overall survival (OS) at the final analysis.

  • The trial compared Opdivo + Yervoy to standard-of-care chemotherapy as a first-line treatment for unresectable or metastatic urothelial carcinoma patients whose tumor cells express PD-L1 ≥1%.

  • Bristol Myers remains blinded to the data, and an independent Data Monitoring Committee recommended that the trial continue to assess other primary and secondary endpoints.

  • No new safety signals were observed.

  • The CheckMate -901 trial is also assessing Opdivo plus Yervoy in unresectable or metastatic urothelial carcinoma patients who are ineligible for cisplatin-based chemotherapy.

  • Also Read: Bristol Myers' Neoadjuvant Opdivo/Chemo Therapy Yet To Reach Overall Survival Endpoint In Early-Stage Lung Cancer.

  • Additionally, a sub-study of CheckMate -901 is evaluating Opdivo combined with chemotherapy versus chemotherapy alone in patients eligible for cisplatin-based chemotherapy.

  • Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 trials in five tumors to date.

  • In addition, Opdivo has shown clinical benefit in second-line metastatic urothelial carcinoma and adjuvant muscle-invasive urothelial carcinoma.

  • Price Action: BMY shares are up 1.03% at $76.59 during the market session on the last check Monday.

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