Summary
The FDA has granted nivolumab (Opdivo) priority review as a neoadjuvant treatment for resectable NSCLC, based on promising CheckMate -816 trial results.
The FDA has granted priority review to nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor, for use with chemotherapy as a neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). Nivolumab is already approved in the U.S. for various oncology indications, including NSCLC, melanoma, and several other cancers. The priority review is based on the CheckMate -816 trial results, which showed significant improvements in event-free survival (EFS) and pathologic complete response rates when nivolumab was combined with chemotherapy, followed by surgery.
The CheckMate -816 trial included 358 patients with resectable NSCLC who were randomized to receive either neoadjuvant platinum doublet chemotherapy with or without nivolumab. The addition of nivolumab to chemotherapy before surgery resulted in better clinical outcomes, with a safety profile consistent with previous NSCLC studies. The primary endpoints of the trial were pathologic complete response and EFS, with secondary endpoints including overall survival (OS), major pathologic response, and time to death or metastasis.
Bristol Myers Squibb is working closely with the FDA to potentially offer this new immunotherapy-based regimen as the first of its kind for pre-surgical treatment to improve disease progression and recurrence outcomes for NSCLC patients. The decision on approval is expected by July 13, and if approved, it would offer a novel treatment option for patients with resectable NSCLC in the U.S.
