On October 3, 2024, the U.S. Food and Drug Administration approved nivolumab (Opdivo) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node-positive) non–small cell lung cancer (NSCLC) and no known EGFR mutations or ALK rearrangements.
Efficacy and Safety
Efficacy was evaluated in CheckMate-77T (ClinicalTrials.gov identifier NCT04025879), a randomized, double-blind, placebo-controlled multicenter trial in 461 patients with previously untreated and resectable NSCLC (stage IIA to select stage IIIB). Patients were randomly assigned (1:1) to either nivolumab or placebo, with platinum-based chemotherapy, every 3 weeks for up to 4 cycles (neoadjuvant treatment) followed by either continued single-agent nivolumab or placebo every 4 weeks for up to 13 cycles (adjuvant treatment).
The major efficacy outcome measure was event-free survival by blinded independent central review. Median event-free survival was not reached (95% confidence interval [CI] = 28.9 months to not estimable) in the nivolumab arm and 18.4 months (95% CI = 13.6–28.1 months) in the chemotherapy arm (hazard ratio = 0.58, 95% CI = 0.43–0.78; P = .00025). At the prespecified interim analysis, overall survival was not formally tested for statistical significance; however, a descriptive analysis revealed no detriment.
Adverse reactions were similar to those occurring in other clinical trials of nivolumab with chemotherapy. Of those who received neoadjuvant nivolumab, 5.3% were unable to undergo surgery because of adverse reactions compared with 3.5% in the placebo arm. In addition, 4.5% who received neoadjuvant treatment and surgery in the nivolumab arm had delays in surgery because of adverse reactions compared with 3.9% in the placebo arm. See the prescribing information for additional safety information.
The recommended nivolumab dosage is 360 mg every 3 weeks (neoadjuvant treatment) and 480 mg every 4 weeks (adjuvant treatment). Nivolumab should be administered prior to chemotherapy when administered on the same day.
