New long-term data for Opdivo in advanced melanoma announced

Source: European Pharmaceutical Review, November, 2015

Bristol-Myers Squibb announced new long-term data of Opdivo (nivolumab) in treatment-naïve BRAF wild-type advanced melanoma from CheckMate -066 at the Society for Melanoma Research (SMR) 2015 International Congress.

In the trial, the treatment continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The two-year survival and safety data from CheckMate -066 represent the longest follow-up from a randomised study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma.

Bristol-Myers Squibb also presented updated data from various Phase 1 cohorts of Study 004 evaluating the Opdivo + Yervoy Regimen in patients with unresectable or metastatic melanoma, including up to three-year overall survival. The Phase 1b Study 004 is a dose-finding study on which the proof of concept for Opdivo + Yervoy Regimen approval was based.