Phase III CheckMate -816 trial of Opdivo meets primary endpoint in NSCLC.- BMS

Bristol Myers Squibb announced that the Phase III CheckMate -816 trial met a primary endpoint of pathologic complete response (pCR) in resectable non-small cell lung cancer (NSCLC). In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate -816 is the first and only Phase III trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC. Patients in the experimental arm of the trial received up to three doses of Opdivo plus chemotherapy prior to surgery, a standard number of cycles of therapy in the neoadjuvant setting. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC. The company will complete a full evaluation of the available CheckMate -816 data, work with investigators to present the results at an upcoming medical conference and discuss potential regulatory options with health authorities. The CheckMate -816 trial is currently ongoing to assess the other primary endpoint of event-free survival (EFS), to which the company remains blinded, as well as key secondary endpoints.