Bristol-Myers: Phase 3 Study Of Opdivo Plus Yervoy Met Co-primary Endpoint

(RTTNews) - Bristol-Myers Squibb Co. (BMY) said that a Phase 3 study evaluating Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma or RCC met its co-primary endpoint, demonstrating superior overall survival or 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 has recommended that the trial be stopped early.

CheckMate -214 is a phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma. Patients in the combination group received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks.

"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," Vicki Goodman, head of new asset development, Bristol-Myers Squibb.

Bristol-Myers noted that 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.