BMS jumps on Phase II data behind Opdivo BLA

Bristol-Myers Squibb Co. (NYSE:BMY) added $4.82 (9%) to $58.98 Thursday when it reported a 15% objective response rate (ORR) and estimated a 41% one-year survival rate in the Phase II CheckMate -063 trial evaluating Opdivo nivolumab as a third-line treatment for squamous cell non-small cell lung cancer (NSCLC). The -063 study is the basis for a rolling BLA submission to FDA that the pharma expects to complete by year end.

The single-arm study evaluated biweekly Opdivo monotherapy in 117 patients with NSCLC who had progressed after at least two prior systemic therapies. An independent review committee observed the 15% ORR at a minimum follow-up of 11 months, the study's primary endpoint. BMS compared the 41% one-year survival rate to a historically expected rate of 5.5-18%. Median overall survival (OS) for Opdivo patients was 8.2 months. ...