Dr Cascone on Perioperative Nivolumab in Resectable NSCLC

“Perioperative nivolumab continued to provide a clinically meaningful EFS benefit compared with perioperative placebo. At a median follow-up of 41 months, we saw a hazard ratio for EFS of in favor of perioperative nivolumab of 0.61.”

Tina Cascone, MD, PhD, an associate professor in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, discussed findings from the phase 3 CheckMate 77T study (NCT04025879) of perioperative nivolumab (Opdivo) vs placebo in patients with resectable non–small cell lung cancer (NSCLC).

Findings from CheckMate 77T presented during the 2025 ASCO Annual Meeting showed that, at a median follow-up of 41.0 months (range, 31.3-59.8), patients who received nivolumab (n = 229) achieved a median event-free survival (EFS) of 46.6 months (95% CI, 35.8-not reached) compared with 16.9 months (95% CI, 13.6-28.2) in the placebo arm (n = 232), Cascone said. The HR for EFS was 0.61 (95% CI, 0.46-0.80), suggesting a sustained benefit with nivolumab vs placebo, Cascone added. The 24- and 30-month EFS rates in the nivolumab arm were 67% and 61%, respectively; these respective rates in the placebo arm were 44% and 43%.

The EFS benefit with nivolumab vs placebo was observed across key patient subgroups, including disease histology and stage, Cascone added. Notably, patients with stage III disease experienced a significant EFS benefit with nivolumab vs placebo (HR, 0.54; 95% CI, 0.39-0.74), she added. An EFS benefit was also reported in patients without PD-L1 expression, with a greater benefit observed in patients with PD-L1–positive disease, she concluded.

In October 2024, the FDA approved perioperative nivolumab in combination with platinum-doublet chemotherapy as neoadjuvant therapyfollowed by single-agent nivolumab after surgery as adjuvant treatment for adults with resectable (tumors ≥ 4 cm and/or node positive) without known EGFR mutations or ALK rearrangements. The regulatory decision was supported by prior data from CheckMate 77T.