Quality of life with cemiplimab plus chemotherapy for first-line treatment of advanced non-small cell lung cancer: Patient-reported outcomes from phase 3 EMPOWER-Lung 3.

Abstract

EMPOWER-Lung 3, a randomized 2:1 phase 3 trial, showed clinically meaningful and statistically significant overall survival improvement with cemiplimabplusplatinum-doublet chemotherapy versus placebopluschemotherapy for first-line treatment of advanced non-small cell lung cancer. This study evaluated patient-reported outcomes (PROs). PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3weeks) for the first six doses, and then at start of every three cycles, using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) and Quality of Life-Lung Cancer Module (QLQ-LC13) questionnaires. Prespecified analyses included a longitudinal mixed-effect model comparing treatment arms and a time to definitive clinically meaningful deterioration (TTD) analysis performed for global health status/quality of life (GHS/QoL) and all scales from the questionnaires. Between-arm TTD comparisons were made using a stratified log-rank test and proportional hazards model. A total of 312 patients were assigned to receive cemiplimabplusplatinum-doublet chemotherapy and 154 to receive placebopluschemotherapy; 391 (83.9%) were male and the median age was 63.0years (range, 25-84). For pain symptoms (EORTC QLQ-C30), a statistically significant overall improvement from baseline (-4.98, 95% confidence interval [CI] -8.36 to -1.60, p=.004) and a statistically significant delayin TTD (hazard ratio, 0.39; 95% CI, 0.26-0.60, p<.0001) favoring cemiplimabpluschemotherapy were observed. Statistically significant delays in TTD, all favoring cemiplimabpluschemotherapy, were also observed in functioning and symptom scales. A significant overall improvement from baseline in GHS/QoL was seen for cemiplimabpluschemotherapy compared with nonsignificant overall change from baseline for placebopluschemotherapy (1.69, 95% CI, 0.20-3.19 vs. 1.08, 95% CI, -1.34 to 3.51; between arms, p=.673). No analyses yielded statistically significant PRO resultsfavoring placebopluschemotherapy for any QLQ-C30 or QLQ-LC13 scale. Cemiplimabpluschemotherapy resulted in significant overall improvement in pain symptoms and delayed TTD in cancer-related and lung cancer-specific symptoms and functions.