Positive results of Checkmate 037 trial for Opdivo (nivolumab) for Advanced Melanoma - BMS

Bristol-Myers Squibb Company announced positive results from CheckMate -037, a Phase III randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator�s choice chemotherapy (ICC) in patients with Advanced Melanoma who were previously treated with Yervoy (ipilimumab). Based on a planned interim analysis of the co-primary endpoint, the objective response rate (ORR) was 32% (95% CI = 24, 41) in the Opdivo arm (n=120) and 11% (95% CI = 4, 23) in the ICC reference arm (n=47) in patients with at least six months of follow up. The majority (95%) of responses were ongoing in the Opdivo arm and the median duration of response was not reached. ORR was based on RECIST criteria as evaluated by an independent radiologic review committee (IRRC). These data were highlighted at a ESMO 2014 Congress press briefing today in Madrid and will be presented during the Presidential Symposium at 4 p.m. CEST (Abstract #LBA3_PR).