Posted: Monday, March 7, 2022
On March 4, the U.S. Food and Drug Administration (FDA) announced its approval of nivolumab (Opdivo) with platinum-doublet chemotherapy for adults with resectable non–small cell lung cancer (NSCLC), the first FDA approval for neoadjuvant therapy for early-stage NSCLC. The recommended nivolumab dose is 360 mg with platinum-doublet chemotherapy on the same day every 3 weeks for three cycles, with common adverse reactions including nausea, constipation, fatigue, decreased appetite, and rash.
Nivolumab’s efficacy was evaluated in the CheckMate 816 (ClinicalTrials.gov identifier NCT02998528), a randomized, open-label trial comprising 358 patients with resectable, histologically confirmed stage IB (≥ 4 cm), II, or IIIA NSCLC (AJCC/UICC staging criteria) and measurable disease. Patients were randomly assigned to receive either nivolumab plus platinum-doublet chemotherapy administered every 3 weeks for up to three cycles or platinum-chemotherapy alone administered on the same schedule. The main efficacy outcome measures were event-free survival and pathologic complete response by blinded independent central review. The median event-free survival was 31.6 months (95% confidence interval [CI] = 30.2 months to not reached) with nivolumab plus chemotherapy and 20.8 months (95% CI = 14.0–26.7 months) with chemotherapy alone.