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Opdivo in Combination with Yervoy Stopped Early for Demonstrating Overall Survival Benefit in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Truckee, CA (UroToday.com) - Bristol-Myers Squibb Company 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.”

The safety and tolerability of the Opdivo plus Yervoy combination observed in CheckMate -214 was consistent with previous reports of this dosing schedule and similar across subgroups.

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