Opdivo Phase III Study Final Results
Bristol Myers Squibb announced the final analysis of overall survival (OS) from the Phase III 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 III 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.”
The company will conduct an analysis of the updated data and plans to provide a comprehensive update on the data in a future peer reviewed setting.
About CheckMate -816
CheckMate -816 is a Phase III randomized, open label, multi-center trial evaluating Opdivo with chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable stage IB to IIIA non-small cell lung cancer (per the 7th edition American Joint Committee on Cancer/Union for International Cancer Control staging criteria), regardless of PD-L1 expression. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for three cycles, or platinum doublet chemotherapy every three weeks for three cycles, followed by surgery. The primary endpoints of the trial are event-free survival and pathologic complete response. Secondary endpoints include overall survival, major pathologic response, and time to death or distant metastases.
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