FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
Regulatory approval: On October 3, 2024, the FDA approved nivolumab with platinum-doublet chemotherapy as neoadjuvant therapy, followed by adjuvant single-agent nivolumab after surgery, for adults with resectable (tumors ≥4 cm and/or node-positive) NSCLC without known EGFR mutations or ALK rearrangements. Approval was supported by CHECKMATE-77T, where event-free survival was improved versus chemotherapy (median not reached vs 18.4 months; HR 0.58). Interim OS was descriptive and showed no detriment.
FDA approval (2024-10-03): perioperative nivolumab for resectable NSCLC
The FDA approved nivolumab (Opdivo) on October 3, 2024 for adults with resectable NSCLC (tumors ≥4 cm and/or node-positive) with no known EGFR mutations or ALK rearrangements. The approved regimen is nivolumab plus platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment.
Efficacy and safety were evaluated in CHECKMATE-77T (NCT04025879), a randomized, double-blind, placebo-controlled multicenter trial (n=461) enrolling previously untreated, resectable NSCLC (stage IIA to select stage IIIB, AJCC 8th). Patients received neoadjuvant nivolumab or placebo with platinum-based chemotherapy every 3 weeks for up to 4 cycles, then adjuvant nivolumab or placebo every 4 weeks for up to 13 cycles.
Primary endpoint event-free survival (EFS) by blinded independent central review: median EFS not reached (95% CI 28.9–NE) with nivolumab vs 18.4 months (95% CI 13.6–28.1) with chemotherapy (HR 0.58, 95% CI 0.43–0.78; p=0.00025). At the prespecified interim analysis, OS was not formally tested; descriptive analysis reported no detriment.
Safety was reported as consistent with known nivolumab + chemotherapy experience. Inability to undergo surgery due to adverse reactions occurred in 5.3% vs 3.5% (placebo); surgery delays occurred in 4.5% vs 3.9%.
Recommended dosing: 360 mg q3w (neoadjuvant) and 480 mg q4w (adjuvant); administer nivolumab prior to chemotherapy on the same day. Review occurred under Project Orbis; reviews at other agencies were ongoing.