First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1

IntroductionIn CheckMate 227 (NCT02477826), patients with treatment-naive stage IV or recurrent NSCLC and 1% greater tumor programmed death ligand 1 expression had significantly improved overall survival nivolumab plus ipilimumab versus chemotherapy. We present the patient-reported outcomes (PROs).MethodsPatients (N = 1189) were randomized to ipilimumab, nivolumab, PROs exploratory. Changes in Lung Cancer Symptom Scale (LCSS) average symptom burden index, LCSS 3-item global EQ-5D visual analog scale (VAS), utility index analyzed descriptively. Mixed-effect model repeated measures time-to-first deterioration improvement analyses conducted.ResultsPRO completion rates generally than 80%. On-treatment improvements from baseline of health status met exceeded minimal important difference (smallest clinically meaningful change) weeks 24 30, respectively; chemotherapy remained below difference. Mean on-treatment VAS scores for both treatments approached U.K. population norm at week 24, remaining so throughout treatment period. revealed numerically across index. Nivolumab delayed (hazard ratio [95% confidence interval] 0.74 [0.56 0.98]) a trend more rapid (1.24 [0.98 1.59]) chemotherapy.ConclusionsNivolumab numerical symptoms health-related quality life advanced expression.