Phase 3 trial of first-line nivolumab-ipilimumab versus chemotherapy for advanced NSCLC in older patients or patients with ECOG performance status 2

The multicenter phase 3 GFPC 08-2015 ENERGY trial in France compared first-line nivolumab plus ipilimumab versus carboplatin-based doublet chemotherapy for stage IV NSCLC without known oncogenic alterations in patient aged 70 years or older with ECOG performance status 0-2 or aged younger than 70 years with ECOG PS 2. The trial was stopped early for futility on the basis of a pre-planned interim analysis after 33% of the expected events had occurred. The median overall survival was 14.7 months with nivolumab plus ipilimumab versus 9.9 months with chemotherapy (HR 0.85; 95% CI 0.62-1.16). In the subgroup of patients aged 70 years or older with ECOG PS 0-1, the median OS was 22.6 months with nivolumab plus ipilimumab versus 11.8 months with chemotherapy (HR 0.64; 95% CI 0.46-0.96). There were no new safety signals. The authors conclude that the study showed no benefit of nivolumab plus ipilimumab over chemotherapy in the overall study population; however, the finding of better OS with nivolumab plus ipilimumab compared with chemotherapy in the subgroup of older patients with ECOG PS 0-1 warrants further study.