FDA Approves Neoadjuvant/Adjuvant Nivolumab for Patients With Resectable Non-Small Cell Lung Cancer

On October 3, 2024, the US Food and Drug Administration (FDA) approved nivolumab plus platinum-doublet chemotherapy followed by surgical resection and single-agent nivolumab for patients with non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This approval was based on results from the CHECKMATE-77T trial. 

In this multicenter, double-blind, placebo-controlled trial, 461 patients with previously untreated NSCLC were randomized to receive either nivolumab or placebo plus platinum-based chemotherapy every 3 weeks for up to 4 cycles followed by surgical resection and either single-agent nivolumab or placebo every 4 weeks for up to 13 cycles. The primary end point was event-free survival (EFS) by blinded independent central review. A key secondary end point was safety. 

At analysis, EFS was not reached in the nivolumab arm and was 18.4 months in the placebo arm (hazard ratio [HR] 0.58; 95% confidence interval [CI], 0.43 to 0.78; P = .00025). While overall survival was not formally tested for statistical significance, at the time of prespecified interim analysis a descriptive analysis revealed no detriment. 

The adverse event profile was consistent with other clinical trials assessing nivolumab plus chemotherapy. Surgical delays due to adverse reactions occurred in 4.5% of patients in the nivolumab arm and 3.9% of patients in the placebo arm. There were 5.3% of patients who were unable to undergo surgery due to adverse events in the nivolumab arm, compared to 3.5% of patients in the placebo arm. 

The recommended dose of nivolumab is 360 mg every 3 weeks as neoadjuvant treatment and 480 mg every 4 weeks as adjuvant treatment. When administered on the same day as chemotherapy, nivolumab should be administered first. 

Source: 

FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer. Accessed on October 3, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-nivolumab-resectable-non-small-cell-lung-cancer