Multicenter phase 3 trial of first-line nivolumab-ipilimumab for 6 months versus continuation in advanced NSCLC: 4-year outcomes

Optimal first-line immunotherapy duration in metastatic non-small cell lung cancer (mNSCLC) with controlled disease is not clear. The multicenter phase 3 DICIPLE trial in France evaluated 6-month nivolumab-ipilimumab in patients with disease control (DC). The trial enrolled treatment-naïve mNSCLC patients (aged 18-75; ECOG performance status 0-1; no actionable genomic alterations) who had DC after 6 month induction treatment with nivolumab plus ipilimumab. Patients were randomized to continue treatment (n=36) or stop and resume at disease progression (experimental group; n=35). The primary outcome was progression-free survival (PFS). Median PFS was 18.7 months in the continuation group versus not reached (NR) in the experimental group. Median overall survival was 55.5 months in the continuation group versus NR in the experimental group, with 18-months OS rate 80.6% versus 93.8%. Grade 3-5 treatment-related adverse events were higher in the continuation group (54.3% versus 23.5%). Median time until definitive quality of life deterioration was 15.5 months in the continuation group versus NR in the experimental group. The authors conclude that stopping nivolumab-ipilimumab after 6 months in in patients with DC did not compromise survival at 4 years, reduced severe adverse events, and delayed worsening of quality of life.