CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 9, 2022—The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting. The treatment is approved regardless of PD-L1 status and is based on the CheckMate -816 trial, the first positive phase three trial of an immunotherapy-based combination used before surgery for resectable NSCLC.
The primary endpoints included event-free survival and pathologic complete response, which were evaluated using independent blinded review, and an additional efficacy outcome measure was overall survival. The study compared Opdivo plus platinum-doublet chemotherapy (n=179) to platinum-doublet chemotherapy alone (n=179). In the trial, Opdivo plus chemotherapy, when given before surgery, showed a statistically significant improvement in event-free survival with a 37 percent reduction in the risk of progression, recurrence, or death (hazard ratio=0.63; 95 percent confidence interval, 0.45–0.87; P=0.0052) compared with chemotherapy alone.