Bristol Myers Squibb announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC). The results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint, compared to neoadjuvant chemotherapy alone. The results build on the previously reported primary endpoints of event-free survival (EFS) and pathological complete response (pCR), which also met statistical significance.

The safety profile of Opdivo in combination with chemotherapy was consistent with previously reported studies, with no new safety signals observed.

“The final analysis of overall survival in the CheckMate -816 study underscores the potential of Opdivo in combination with chemotherapy to provide a meaningful survival benefit for patients with resectable NSCLC,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, late development, oncology, Bristol Myers Squibb. “This is the first and only Phase 3 study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant benefit in patients with resectable NSCLC. Opdivo -based therapies have shown improved efficacy in the neoadjuvant and perioperative treatment of patients with resectable NSCLC.”