Successful Phase II two year results of Checkmate 069 study of Opdivo (nivolumab) and Yervoy (ipilimumab) combination in advanced melanoma- BMS

Bristol-Myers Squibb Company announced first time presentation of overall survival data from CheckMate-069, a Phase II trial and the first randomized study to evaluate the Opdivo (nivolumab) and Yervoy (ipilimumab) combination regimen in patients with previously untreated advanced melanoma.

In the trial, the nivolumab/ipilimumab combination regimen demonstrated a two-year overall survival (OS) rate of 69% compared to 53% for ipilimimumab alone (HR=0.58 [95% CI: 0.31–1.08]) in patients with BRAF wild-type advanced melanoma. Overall survival was an exploratory endpoint in this trial. The safety profile of the combination regimen in this study was consistent with previously reported studies. These data were presented as an oral presentation at the American Association for Cancer Research (AACR) 2016 Annual Meeting during the Immuno-Oncology Clinical Trials I Plenary Session

Comment: The nivolumab/ipilimumab combination was licensed in the US but not yet licensed in the EU. As single agents, both drugs are approved in the EU to treat adult patients with non-resectable melanoma. The CHMP has recommended that the combination be licensed for use in Europe and a formal decision is expected in the first half of 2016.