Adjuvant Nivolumab Did Not Improve Disease Free Survival After Resected NSCLC

An open-label, phase 3 randomized clinical trial published in JAMA found that adjuvant nivolumab (Opdivo; Bristol-Myers Squibb) did not improve disease-free survival (DFS) compared with observation in patients with resected non-small cell lung cancer (NSCLC).

The Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) trial, also known as EA5142, evaluated nivolumab after surgical resection and planned standard adjuvant chemotherapy and/or radiotherapy. The study enrolled patients with resected tumors measuring at least 4cm and/or node-positive disease. Eligible adenocarcinoma cases with sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) variants were excluded.

Participants were randomly assigned to receive nivolumab 480mg intravenously every 4 weeks for up to 1 year or standard-care observation. In the intention-to-treat population, median DFS was 71.3 months with nivolumab and 68.8 months with observation, with a hazard ratio of 0.97.

Among patients with programmed death ligand 1 (PD-L1) expression of at least 50%, median DFS was 89.8 months with nivolumab and 78.5 months with observation. The hazard ratio in this subgroup was 0.86, and the study did not show a statistically significant benefit.

The National Cancer Institute Network–funded trial was stopped for futility at 75% information. The authors concluded that EA5142 was a negative study.

Source(s): JAMA (June 1, 2026)