Perioperative Nivolumab Prolonged Event-Free Survival Compared to Perioperative Chemotherapy Among Patients With Resectable Non-Small Cell Lung Cancer

Results from the phase 3 CheckMate 77T trial demonstrated that perioperative nivolumab prolonged event-free survival (EFS) compared to perioperative chemotherapy among patients with resectable non-small cell lung cancer (NSCLC).

According to Tina Cascone, MD, PhD, MD Anderson Cancer Center, Houston, Texas, and coauthors, “Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable NSCLC [however] perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes.” 

In this multi-national, double-blind study, 461 patients with stage IIA to IIIB NSCLC were enrolled. Patients were randomized to receive neoadjuvant nivolumab plus chemotherapy (n = 229) or neoadjuvant chemotherapy plus placebo (n = 232) every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for a duration of 1 year. The primary end point was EFS. Secondary end points included pathological complete response (pCR), major pathological response, and safety. 

At a median follow-up of 25.4 months, the percentage of patients with 18-month EFS was 70.2% in the nivolumab arm and 50% in the chemotherapy arm (hazard ratio [HR] 0.58; 97% confidence interval [CI], 0.42 to 0.81; P < .001). In the nivolumab arm, 25.3% of patients experienced a pCR vs 4.7% of patients in the chemotherapy arm, and a major pathological response occurred in 35.4% of patients and 12.1% of patients, respectively. Grade 3/4 treatment-related adverse events occurred in 32.5% of patients in the nivolumab arm and 25.2% of patients in the chemotherapy arm. 

As Dr Cascone et al concluded, “Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC.”

Source: 

Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. Published online: May 15, 2024. doi:10.1056/NEJMoa2311926