CheckMate-816 Shows Significant Improvement in OS With Neoadjuvant Nivolumab Plus Chemotherapy for Resectable NSCLC

The final analysis of overall survival (OS) from the phase 3 CheckMate-816 trial showed a “statistically significant and clinically meaningful improvement” in OS with the addition of nivolumab (Opdivo) to platinum-doublet chemotherapy as a neoadjuvant treatment for resectable non–small cell lung cancer (NSCLC), according to an announcement from Bristol Myers Squibb.

This makes the combination treatment the “first and only neoadjuvant-only immuno-oncology therapy to demonstrate statistically significant and clinically meaningful overall survival” in resectable NSCLC, according to Bristol Myers Squibb.

The randomized phase 3 trial evaluated nivolumab plus platinum-doublet chemotherapy as a neoadjuvant treatment and compared it with neoadjuvant chemotherapy alone in adults with resectable stage IB to IIIA NSCLC (tumors ≥ 4 cm or node positive), regardless of programmed cell death ligand 1 (PD-L1) expression.

In the primary analysis of CheckMate-816, investigators randomized 358 patients to receive either nivolumab 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. OS was a key secondary endpoint of the trial, and these results “build on the previously reported primary endpoints of event-free survival (EFS) and pathological complete response (pCR), which also met statistical significance,” officials said.

Dana Walker, MD, MSCE, vice president, global program lead, late development for oncology at Bristol Myers Squibb, weighed in on the results in a statement.

“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,” Dr. Walker said. “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.”

Company officials said Bristol Myers Squibb will “conduct an analysis of the updated data and plans to provide a comprehensive update on the data in a future peer reviewed setting.”

Source: Bristol Myers Squibb