Perioperative nivolumab shows significant efficacy in lung cancer treatment

When compared with pre-surgical (neoadjuvant) chemotherapy only, adding perioperative immunotherapy before and after surgery significantly improves event-free survival in patients with resectable early-stage non-small cell lung cancer (NSCLC), researchers reported on May 15, 2024 in the NEJM/New England Journal of Medicine.

“This study builds on the standard-of-care neoadjuvant chemoimmunotherapy treatment and supports perioperative nivolumab as an effective approach that reduces the risk of lung cancer relapse,” said principal investigator Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head & Neck Medical Oncology, University of Texas M,D, Anderson Cancer Center in Houston. “These findings add to evidence that the perioperative immunotherapy path gives patients with operable lung cancer an opportunity to live longer without their cancer returning,” he added.

In In the CheckMate 77T trial, the investigators randomized adult subjects with resectable stage IIA to IIIB NSCLC to neoadjuvant treatment with nivolumab plus chemotherapy or neoadjuvant chemotherapy treatment plus placebo every 3 weeks for 4 cycles. This was followed by surgery for all subjects and adjuvant nivolumab or placebo every 4 weeks for 1 year.

The primary outcome was event-free survival.

At this time of the prespecified interim analysis (median follow-up, 25.4 months), the percentage of patients with 18-month event-free survival was 70.2% in the nivolumab group and 50.0% in the chemotherapy group, a statistically significant difference (P<0.001).

The investigators found a pathological complete response in 25.3% of the patients in the nivolumab cohort and in 4.7% of those in the chemotherapy cohort. They reported a major pathological response of 35.4% in the nivolumab group and 12.1% in the chemotherapy group.

They reported Grade 3 or 4 treatment-related adverse events in in 32.5% of the patients in the nivolumab group and 25.2% of the chemotherapy group.

The authors concluded, “Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC. No new safety signals were observed.”

Cascone added, “I am enthusiastic about the initial findings of the study. Looking ahead, it will be critical to identify patient and disease characteristics that will tell us who can potentially be cured with neoadjuvant chemoimmunotherapy only and who will benefit from more intensified treatment strategies.”