FDA Approves Neoadjuvant, Adjuvant Nivolumab for Resectable NSCLC

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb Company) plus platinum-doublet chemotherapy as a neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment. The approval is for adults with non-small cell lung cancer (NSCLC) who have resectable tumors that are at least 4 cm and/or node-positive and no known EGFR mutations or ALK rearrangements, according to the FDA announcement.

The CheckMate 77T trial evaluated the efficacy of the treatment in 461 patients with previously untreated and resectable stage IIA to IIIB NSCLC. Investigators of the double-blind placebo-controlled study randomized patients 1:1 to receive neoadjuvant treatment with nivolumab or placebo with platinum-based chemotherapy every three weeks for up to 4 cycles, followed by adjuvant treatment with continued single-agent nivolumab or placebo every four weeks for up to 13 cycles.

The major efficacy outcome measure in CheckMate 77T was event-free survival (EFS) by blinded independent central review. The study showed that the median EFS was not reached (95% CI, 28.9-not estimable [NE]) in patients receiving nivolumab, compared to 18.4 months (95% CI, 13.6-28.1) in those receiving chemotherapy (hazard ratio, 0.58; 95% CI, 0.43, 0.78; P=.00025).

Overall survival (OS) was “not formally tested for statistical significance” at the prespecified interim analysis, but “a descriptive analysis revealed no detriment,” according to the FDA. Adverse reactions reported in CheckMate-77T were “similar to those occurring in other clinical trials of nivolumab with chemotherapy,” FDA officials said.

Among patients who received neoadjuvant nivolumab, 5.3% were unable to undergo surgery due to adverse reactions, compared to 3.5% of those who were receiving the placebo. Delays in surgery due to adverse reactions were reported in 4.5% of patients who received nivolumab, compared to 3.9% of those receiving placebo.

The recommended dosage is nivolumab 360 mg every three weeks during neoadjuvant treatment and 480 mg every four weeks during adjuvant treatment. Nivolumab should be administered prior to chemotherapy when administered on the same day, FDA officials said.

Source: FDA