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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.
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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