1443P - Patient-reported outcomes (PROs) with cemiplimab plus chemotherapy (CEMI + CHEMO) for first-line treatment of advanced non-small cell lung cancer (aNSCLC): PD-L1 level subgroups in EMPOWER-Lung 3

Background

In EMPOWER-Lung 3 (NCT03409614), a Ph 3 double-blind randomised 2:1 trial, CEMI + CHEMO (n=312) vs placebo (PBO) + CHEMO (n=154) was evaluated as 1st-line treatment for aNSCLC with any PD-L1 expression level. OS and PFS across PD-L1 level subgroups <1%, 1–49% and ≥50% were previously reported. Exploratory analyses were conducted to evaluate PROs across these subgroups.

Methods

PROs were assessed using the EORTC QLQ-C30 and QLQ-LC13 questionnaires. A longitudinal mixed-effect model for repeated measures analysis was used to compare treatment groups for global health status (GHS)/quality of life (QoL) and all functional and symptom scales. Time to definitive clinically meaningful deterioration (TTD) was compared between treatment groups; comparisons were made using a stratified log-rank test and proportional hazards model.

Results

Significant delays in TTD favouring CEMI + CHEMO vs PBO + CHEMO was observed in pain and alopecia across PD-L1 subgroups. Significant delays in TTD favouring CEMI + CHEMO was observed in cognitive functioning and haemoptysis in PD-L1 <1%; in physical, role and emotional functioning and symptoms of fatigue, nausea/vomiting, dyspnoea and dysphagia in PD-L1 1–49%; and in role functioning and symptoms of dyspnoea, coughing, haemoptysis and sore mouth in PD-L1 ≥50%. CEMI + CHEMO resulted in significant favourable differences vs PBO + CHEMO in overall change from baseline in pain symptoms in both PD-L1 <1% and 1–49%. Statistically significant overall change from baseline favouring CEMI + CHEMO was also observed in cognitive functioning in PD-L1 <1%; in emotional functioning in PD-L1 1–49%; and in symptoms of coughing and alopecia in PD-L1 ≥50%. The differences in overall change from baseline and delay in TTD for GHS/QoL numerically favoured CEMI + CHEMO vs PBO + CHEMO across all PD-L1. No analyses yielded statistically significant PRO results favouring PBO + CHEMO on any QLQ-C30 or QLQ-LC13 scale.

Conclusions

Across PD-L1 subgroups in patients with aNSCLC, CEMI + CHEMO resulted in significant overall improvement and delayed TTD in multiple patient-reported functioning and cancer-related and lung cancer–specific symptoms.

Clinical trial identification

NCT03409614.

Editorial acknowledgement

Editorial support was provided by Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc., and Sanofi.

Funding

Regeneron Pharmaceuticals, Inc., and Sanofi.

Disclosure

A. Baramidze: Financial Interests, Personal, Other, Travel support: Regeneron Pharmaceuticals, Inc. X. He, G. Gullo, P. Rietschel, R.G.W. Quek: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.