Nivolumab Plus Chemotherapy Demonstrates Significant Survival Benefit in Resectable NSCLC

The CheckMate -816 trial shows nivolumab (Opdivo) plus platinum-doublet chemotherapy significantly improves overall survival in resectable non-small cell lung cancer. This combination, used neoadjuvantly, met statistical significance for OS, building on prior event-free survival and complete response data.

Bristol Myers Squibb has announced final overall survival (OS) results from the Phase 3 CheckMate -816 trial, evaluating nivolumab combined with platinum-doublet chemotherapy as neoadjuvant therapy for adult patients with resectable non-small cell lung cancer (NSCLC). These data mark the first time a neoadjuvant-only immuno-oncology therapy has demonstrated a statistically significant and clinically meaningful improvement in overall survival in resectable NSCLC.

“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. 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,” said Dr. Dana Walker, Vice President, Global Program Lead, Oncology, at Bristol Myers Squibb.

The CheckMate -816 Trial

CheckMate -816 is a Phase 3 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, 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.

Key Findings

• Overall Survival (OS): The final analysis demonstrated that patients receiving Opdivo plus chemotherapy achieved a statistically significant and clinically meaningful improvement in OS compared to those receiving chemotherapy alone. This result builds upon the previously reported improvements in event-free survival and pathological complete response, underlining the robust efficacy of this regimen.
• Safety Profile: The combination of Opdivo and chemotherapy showed a safety profile consistent with earlier studies. No new safety signals emerged, reinforcing the combination’s tolerability in the neoadjuvant setting.
• Neoadjuvant-Only Milestone: These findings represent a critical milestone as the first and only Phase 3 trial to demonstrate a survival advantage with neoadjuvant-only immuno-oncology therapy in resectable NSCLC.

The CheckMate -816 trial’s landmark findings solidify the potential of Opdivo plus chemotherapy in improving survival for patients with resectable NSCLC. These results, coupled with previously demonstrated improvements in EFS and pCR, mark a notable advancement in the neoadjuvant treatment landscape.

Bristol Myers Squibb plans to conduct further data analyses and expects to share these findings in a future peer-reviewed publication, offering additional context and detail for oncologists and other healthcare professionals.