Officials with the FDA have approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable non–small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase rearrangements.1,2
Researchers evaluated efficacy in CHECKMATE-77T (NCT04025879), a double-blind, placebo-controlled multicenter trial in which 461 patients with previously untreated and resectable NSCLC were randomly assigned in a 1-to-1 fashion to receive either nivolumab or placebo, with platinum-based chemotherapy, every 3 weeks for up to 4 cycles followed by either continued single-agent nivolumab or placebo every 4 weeks for up to 13 cycles.
Median event-free survival was not reached (95% CI: 28.9, not estimable) in the nivolumab arm and 18.4 months (95% CI, 13.6-28.1) in the chemotherapy arm (HR, 0.58; 95% CI, .43-.78; P=.00025). The researchers explained at the prespecified interim analysis, overall survival was not formally tested for statistical significance; however, a descriptive analysis revealed no detriment.
Of those who received neoadjuvant nivolumab, 5.3% were unable to undergo surgery due to 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 due to adverse reactions compared with 3.9% in the placebo arm.
References
- U.S. Food and Drug Administration approves perioperative treatment ofneoadjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvantsingle-agent Opdivo for resectable non-small cell lung cancer (NSCLC).Press release. Bristol Myers Squibb. October 3, 2024. Accessed October 10, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Approves-Perioperative-Treatment-of-Neoadjuvant-Opdivonivolumab-and-Chemotherapy-Followed-by-Surgery-and-Adjuvant-Single-Agent-Opdivo-for-Resectable-Non-Small-Cell-Lung-Cancer-NSCLC/default.aspx
- FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small celllung cancer. Press release. FDA. October 3, 2024. Accessed October 10, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approvesneoadjuvantadjuvant-nivolumab-resectable-non-small-cell-lung-cancer