FDA Approves Perioperative Nivolumab Regimen for NSCLC

The FDA approved neoadjuvant nivolumab (Opdivo) plus platinum-doublet chemotherapy followed by adjuvant single-agent nivolumab for patients with resectable non-small cell lung cancer (NSCLC) with no known EGFR mutations or ALK rearrangements, according to a statement from the agency.

The approval is based on findings from the randomized CHECKMATE-77T trial, which included 461 patients with previously untreated stage IIA to IIIB NSCLC. Participants were randomized 1:1 to receive either nivolumab or placebo with platinum-based chemotherapy every 3 weeks for up to 4 cycles in the neoadjuvant setting. Patients then underwent surgery and received either single agent nivolumab or placebo every 4 weeks for 13 cycles in the adjuvant setting.

The main goal of the trial was event-free survival (EFS), which was not reached in the nivolumab arm (95% CI, 28.9-not estimable [NE]), whereas it was 18.4 months (95% CI, 13.6-28.1) in the placebo group.

At the time of analysis, overall survival (OS) was not formally tested for statistical significance, although the researchers did describe that there was no OS detriment with nivolumab, according to the FDA’s statement.

Adverse events (AEs) were similar to what has previously been seen with nivolumab plus chemotherapy. Among those who underwent neoadjuvant nivolumab, 5.3% were unable to undergo surgery due to AEs, compared with 3.5% in the placebo arm. Also, a total of 4.5% of patients who had neoadjuvant nivolumab experienced surgery delays, compared with 3.9% in the placebo group.

The recommended dosage of nivolumab in the neoadjuvant setting is 360 mg every 3 weeks, and then 480 mg every 4 weeks in the adjuvant setting. Of note, the FDA mentioned that nivolumab should be administered before chemotherapy, and both should be given on the same day.