112P Patient-reported outcomes (PROs) with first-line (1L) cemiplimab in patients with locally advanced non-small cell lung cancer (laNSCLC): EMPOWER-Lung 1 subpopulation

Abstract

Previously reported post hoc exploratory subgroup analysis of the phase 3 EMPOWER-Lung 1 study (NCT03088540) demonstrated improvement with cemiplimab (n=45) versus chemotherapy (chemo) (n=42) in overall survival (12-month OS, 78.5% vs 57.8%; hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.20, 1.14; P=0.09) and progression-free survival (median, 8.4 vs 6.2 months; HR, 0.49; 95% CI, 0.27, 0.88; P=0.02), in patients with laNSCLC (IIIB–IIIC) and programmed cell death-ligand 1 (PD-L1) ≥50% who were not candidates for definitive chemoradiation. Post hoc exploratory analyses evaluated PROs in this subgroup. PROs were assessed at baseline (BL) and Day 1 of each treatment cycle for the first 6 cycles, then on Day 1 of every third cycle using European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer module (QLQ-LC13) questionnaires. Higher scores indicate better functioning, improved global health status (GHS)/quality of life (QoL), or worse symptom severity. Mixed model for repeated measures analyses compared overall change from BL scores between the two treatment arms, while controlling for BL characteristics. PRO scores at BL were broadly similar between the cemiplimab and chemo arms. A significant overall change from BL in GHS/QoL favouring cemiplimab (6.27; 95% CI, 0.62, 11.93; P=0.0302) was observed. Cemiplimab led to significant favourable overall change from BL versus chemo in nausea/vomiting (-6.06; 95% CI, -9.07, -3.06; P=0.0002), dyspnoea (-11.82; 95% CI, -21.71, -1.92; P=0.0201), appetite loss (-9.39; 95% CI, -15.76, -3.02; P=0.0047), peripheral neuropathy (-7.54; 95% CI, -13.40, -1.68; P=0.0125) and alopecia (-22.03; 95% CI, -31.37, -12.68; P<0.0001). No analyses yielded significant PRO results favouring chemo for any scale. In this post hoc analysis of patients with laNSCLC and PD-L1 ≥50%, cemiplimab resulted in significant favourable overall change from BL in GHS/QoL and important cancer-related and lung cancer–specific symptoms versus chemo. PRO results further support the favourable benefit-risk profile of 1L cemiplimab versus chemo in laNSCLC with PD-L1 ≥50%.