FDA’s Opdivo Lung Cancer Approval

By João L. Carapinha

October 11, 2024

The FDA has approved a new treatment regimen using Opdivo (nivolumab) for resectable non-small cell lung cancer (NSCLC), marking a significant advancement in cancer care. This approval paves the way for adult patients with resectable NSCLC to receive a combination of Opdivo and platinum-doublet chemotherapy as a neoadjuvant therapy, followed by surgery, and then adjuvant single-agent Opdivo. This targeted approach is for patients who do not have epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) rearrangements.

Approval Details

The FDA has approved Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment, followed by surgery, and then adjuvant single-agent Opdivo for adult patients with resectable NSCLC. This approval specifically targets patients without EGFR or ALK rearrangements.

Clinical Trial

The approval is based on the results of the Phase III CheckMate-77T trial, a randomized, double-blind, multi-center study. The trial involved 461 patients and compared neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant single-agent Opdivo against neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo.

Efficacy

Results demonstrated that the combination of Opdivo with chemotherapy significantly enhanced event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone. Notably, the median EFS was not reached in the nivolumab arm, while it stood at 18.4 months in the chemotherapy arm (HR, 0.58; 95% CI, 0.43-0.78; P = 0.00025).

Safety

Adverse events (AEs) were comparable to those seen in previous clinical trials involving nivolumab and chemotherapy. A small portion of patients treated with nivolumab experienced delays in surgery or were unable to undergo the procedure due to AEs.

Clinical Implications

This FDA approval represents a critical step in addressing the treatment needs of patients requiring therapies before and after surgery to target micrometastasis, lower the risk of cancer recurrence, and enhance surgical success. This regimen holds promise for improved EFS and may lead to a pCR in one out of four patients.

Expanded Role of Opdivo

The FDA’s decision expands the role of Opdivo-based treatments, building upon prior approvals for neoadjuvant-only Opdivo plus chemotherapy for resectable NSCLC, as demonstrated in the CheckMate-816 trial. This reinforces Bristol Myers Squibb’s commitment to enhancing patient outcomes and broadening its thoracic portfolio in early-stage diseases, with Opdivo now playing a pivotal role in treatment protocols for resectable NSCLC.

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