Bristol Myers Squibb’s Opdivo Reached Primary Endpoint in an Interim Analysis of Phase 3 CheckMate -816 Trial in Patients with NSCLC

Bristol Myers Squibb’s Opdivo Reached Primary Endpoint in an Interim Analysis of Phase 3 CheckMate -816 Trial in Patients with NSCLC

Bristol Myers Squibb announced data from a prespecified interim analysis of the Phase 3 CheckMate -816, which is evaluating Opdivo (nivolumab) plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable non-small cell lung cancer, regardless of PD-L1 expression. In the interim analysis Opdivo plus chemotherapy met the primary endpoint of improved event-free survival (EFS) compared to chemotherapy alone when given before surgery. The company previously reported that this combination showed a significant improvement of pathologic complete response (pCR), the trial’s other primary endpoint. 

CheckMate -816 is a randomized, open label trial. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for three doses, or platinum doublet chemotherapy every three weeks for three doses, followed by surgery. The primary endpoints of the trial are pathologic complete response (pCR) and event-free survival (EFS). Secondary endpoints include overall survival (OS), major pathologic response (MPR), and time to death or distant met...

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