Nivolumab Enhances Event-Free Survival in Resectable NSCLC in CheckMate 77T Trial
The phase 3 CheckMate 77T trial demonstrated that adding nivolumab to perioperative chemotherapy improved outcomes for patients with resectable stage IIA to IIIB non–small-cell lung cancer (NSCLC). These benefits included longer event-free survival (EFS) and better pathological responses compared with chemotherapy alone.
Perioperative treatment strategies for resectable stage IIA to IIIB NSCLC remain a critical area of research, as the risk of recurrence or disease progression after surgery remains high. Standard care with neoadjuvant chemotherapy has shown limited long-term benefits. The CheckMate 77T trial was conducted to evaluate whether incorporating nivolumab, a PD-1 inhibitor, into the perioperative regimen could improve outcomes.
In this randomized, double-blind phase 3 trial, adult patients with resectable stage IIA–IIIB NSCLC (N = 461) were assigned to receive either neoadjuvant nivolumab plus chemotherapy or chemotherapy alone every 3 weeks for four cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for up to 1 year. The primary endpoint was EFS, with secondary endpoints including pathological complete response (pCR), major pathological response, overall survival, and safety. Baseline characteristics were balanced between groups, though Black patients were underrepresented.
At a median follow-up of 25.4 months, the 18-month EFS rate was significantly higher in the nivolumab group (70.2%) compared with the chemotherapy group (50.0%; hazard ratio [HR] = 0.58; 97.36% CI, 0.42 to 0.81; P < .001). Nivolumab also demonstrated markedly better pathological outcomes, with a pCR observed in 25.3% of patients in the nivolumab group compared with 4.7% in the chemotherapy group (odds ratio [OR] = 6.64; 95% CI, 3.40 to 12.97), and a major pathological response occurring in 35.4% and 12.1% of patients, respectively (OR = 4.01; 95% CI, 2.48 to 6.49). Surgical outcomes were similar between groups, with lobectomy being more common in the nivolumab group (79.8% vs. 71.9%) and pneumonectomy less frequent (9.0% vs. 13.5%). Safety data showed a slightly higher incidence of grade 3 or 4 treatment-related adverse events in the nivolumab group (32.5% vs. 25.2%), although no new safety signals were identified. Additionally, patients in the nivolumab group experienced a longer time to deterioration in disease-related symptoms, with a median of 40.0 months compared with 31.1 months in the chemotherapy group (HR = 0.66; 95% CI, 0.45 to 0.98).
The study's limitations include the underrepresentation of Black patients, a limitation consistent with other trials in this field.
“Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC,” the study authors concluded. “No new safety signals were observed.”
Reference
Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769. doi:10.1056/NEJMoa2311926
