Neoadjuvant/Adjuvant Nivolumab With Chemotherapy Approved for Resectable NSCLC

By: JNCCN 360 Staff
Posted: Friday, October 4, 2024

Yesterday, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor 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. For full prescribing information, visit accessdata.fda.gov.

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 receive 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 nivolumab in the neoadjuvant setting, 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.

The recommended dosage of nivolumab 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.

U.S. Food and Drug Administration

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