Adjuvant nivolumab confers no DFS benefit in resected NSCLC

In the treatment of patients with resected non–small cell lung cancer (NSCLC) without sensitizing EGFR and ALK alterations, adjuvant nivolumab does not appear to yield improvements in disease-free survival (DFS) when given after planned adjuvant chemotherapy and/or radiotherapy, according to a phase 3 study.

The open-label phase 3 study involved patients with resected tumours ≥4 cm and/or who were lymph node positive (N1/N2). Patients were eligible for inclusion after completion of planned standard adjuvant therapy if the tumour was adenocarcinoma without sensitizing sequence variants in EGFR and ALK or squamous cell carcinoma.

Patients were randomly assigned to receive nivolumab 480 mg intravenously every 4 weeks for up to 1 year (n=466, median age 66 years, 52 percent male) or undergo standard care observation (n=469, median age 67 years, 52 percent male).

The primary endpoint of DFS was assessed in the intention-to-treat population and among those with tumoral PD-L1 expression >50 percent. Overall survival was assessed if the corresponding test for DFS met statistical significance.

The trial was terminated prematurely due to futility. Over a median follow-up of 72.6 months, median DFS was 71.3 months in the nivolumab group vs 68.8 months in the observation group (hazard ratio [HR], 0.97, 95 percent confidence interval [CI], 0.81–1.17; p=0.39).

In the subset of patients with PD-L1 of ≥50 percent, median DFS was 89.8 months in the nivolumab group vs 78.5 months in the observation group (HR, 0.86, 95 percent CI, 0.59–1.25; p=0.22).