Perioperative Nivolumab-Based Regimen Under Review for Resectable NSCLC

The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab, for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). 

The application is supported by data from the randomized, double-blind, placebo-controlled, phase 3 CheckMate -77T trial (ClinicalTrials.gov Identifier: NCT04025879), which included 452 treatment-naive patients with resectable stage IIA to IIIB NSCLC. Study participants were randomly assigned to receive either neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab or neoadjuvant chemotherapy plus placebo followed by surgery and adjuvant placebo. The primary endpoint was event-free survival (EFS).

At a median follow-up of 25.4 months, treatment with nivolumab reduced the risk of disease recurrence, progression or death by 42% (EFS hazard ratio [HR], 0.58; 97.36% CI, 0.42-0.81; P =.00025). Moreover, a greater proportion of patients in the nivolumab arm achieved pathologic complete response (25.3% vs 4.7%) and major pathologic response (35.4% vs 12.1%) compared with the placebo arm. The study is ongoing to assess another secondary endpoint, overall survival (OS).

The safety profile of nivolumab was consistent with previously reported studies in NSCLC. No new safety signals were identified. 

“Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence,” said Abderrahim Oukessou, MD, vice president, thoracic cancers global program lead, Bristol Myers Squibb. “We are working to expand options that improve outcomes for patients with resectable disease, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages.”

A Prescription Drug User Fee Act target date of October 8, 2024 has been set for the application.

Nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, is currently marketed under the brand name Opdivo for the following NSCLC indications:

• Adults with resectable (tumors ≥4cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.
• Adults with metastatic NSCLC expressing PD-L1 (≥1%), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab.
• Adults with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. 
• Adults with metastatic NSCLC and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.

This article originally appeared on MPR