EC approves Opdivo plus Yervoy combo for RCC

The European Commission accepted for review a Type II variation from Bristol-Myers Squibb Co. (NYSE:BMY) to expand the indications for Opdivo nivolumab in combination with Yervoy ipilimumab to include treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The application is based on data from the Phase III CheckMate -214 trial, which was stopped early based on an IDMC recommendation after the combination met the trial's co-primary endpoint of improving overall survival (OS) vs. Sutent sunitinib in intermediate- and poor-risk patients (see BioCentury, Sept. 8).

The combination is already approved in the EU to treat metastatic melanoma. Opdivo is a human IgG4 mAb against PD-1 and Yervoy is a human mAb against cytotoxic T-lymphocyte associated protein 4 (CTLA-4; CTLA4; CD152)...