Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial

Area of Science:

• Oncology
• Immunotherapy
• Clinical Trials

Background:

• Preoperative and perioperative nivolumab have shown benefits in resectable non-small cell lung cancer (NSCLC).
• The efficacy of adjuvant nivolumab after initial surgery for NSCLC remains undetermined.

Purpose of the Study:

• To assess if adjuvant nivolumab improves disease-free survival (DFS) and overall survival (OS) in patients with resected NSCLC.
• To evaluate outcomes based on programmed death-ligand 1 (PD-L1) expression levels (any expression and ≥50%).

Main Methods:

• An open-label, randomized phase 3 trial (NCT02595944) involving 935 patients with resected NSCLC.
• Eligible patients had tumors ≥4 cm and/or lymph node involvement, with specific criteria for adenocarcinoma and squamous cell carcinoma.
• Patients received either adjuvant nivolumab (480 mg every 4 weeks for up to 1 year) or standard care observation.

Main Results:

• The study was stopped early for futility.
• In the intention-to-treat population, median DFS was 71.3 months with nivolumab vs. 68.8 months with observation (HR, 0.97; P=.39).
• In patients with PD-L1 ≥50%, median DFS was 89.8 months with nivolumab vs. 78.5 months with observation (HR, 0.86; P=.22).

Conclusions:

• Adjuvant nivolumab did not significantly improve disease-free survival in patients with resected NSCLC.
• The findings suggest that adjuvant nivolumab is not associated with improved DFS in this patient population when administered after standard adjuvant therapy.