EMA approves Opdivo + Yervoy (nivolumab + ipilimumab) for advanced melanoma- BMS

Bristol-Myers Squibb announced that the European Commission (EC) has approved Opdivo + Yervoy (nivolumab + ipilimumab) for the treatment of advanced (unresectable or metastatic) melanoma in adults, representing the first and only approved combination of two Immuno-Oncology agents in the European Union (EU). Approval covers unresectable or metastatic melanoma patients, regardless of BRAF mutational status.

Approval was based on CheckMate -067, the first Phase III, double-blind, randomized study, in which the Opdivo + Yervoy Regimen and Opdivo monotherapy demonstrated superior progression-free survival (PFS) and objective response rates (ORR) in patients with advanced melanoma, regardless of BRAF mutational status, versus Yervoy alone. The safety profile was consistent with previously reported studies evaluating the Opdivo + Yervoy Regimen, and most treatment-related adverse events were managed using established algorithms.

The approval was also based on supportive data from the Phase II study, CheckMate -069, in which the Opdivo + Yervoy Regimen demonstrated an ORR, the primary endpoint, of 61% in patients with BRAF wild-type advanced melanoma, versus 11% ORR in the Yervoy monotherapy arm, with a minimum follow-up of 11 months. The estimated 12- and 18-month overall survival (OS) rates were 79% and 73%, respectively, for the Opdivo + Yervoy Regimen, and 62% and 56%, respectively, for Yervoy monotherapy. The OS data are based on an exploratory, pre-planned analysis of patients with BRAF wild-type advanced melanoma. This approval allows for the marketing of the Opdivo + Yervoy Regimen in all 28 Member States of the EU.