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Bristol-Myers Squibb (BMY) Release: Checkmate -214 Study Evaluating Opdivo In Combination With Yervoy Stopped Early For Demonstrating Overall Survival Benefit In Patients With Previously Untreated Advanced Or Metastatic Renal Cell Carcinoma



9/7/2017 7:03:22 AM

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Opdivo (nivolumab) plus Yervoy (ipilimumab) showed superior overall survival versus current standard of care sunitinib in intermediate- and poor-risk patients, a co-primary endpoint

The combination of Opdivo and Yervoy also met the secondary endpoint of improved overall survival in all randomized patients

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that a Phase 3 study evaluating Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) met its co-primary endpoint, demonstrating superior overall survival (OS) compared to sunitinib in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved OS versus sunitinib in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.

“This overall survival result from CheckMate -214 highlights the potential of the combination of Opdivo and Yervoy to provide a new treatment option for first-line advanced renal cell carcinoma patients for whom there is a considerable unmet need,” said Vicki Goodman, M.D., head of new asset development, Bristol-Myers Squibb. “The company looks forward to sharing the full results with regulatory authorities and will incorporate these data into the planned European Society for Medical Oncology (ESMO) Congress presentation later this week.”


Read at BioSpace.com


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