Abstract 1183P
Background
In Phase 3 EMPOWER-Lung 1 study of aNSCLC with PD-L1 ≥50% (NCT03088540), improvement in overall survival was observed with cemiplimab monotherapy vs platinum-doublet chemotherapy by histology subgroups (squamous: HR 0.48, 95% CI [0.30,0.77]; non-squamous: HR 0.64, 95% CI [0.43,0.96]). Post-hoc exploratory PROs analyses were conducted in both subgroups.
Methods
PROs were assessed at baseline and Day 1 of each treatment cycle for the 1st 6 cycles, and then on Day 1 of every 3rd cycle using the EORTC QLQ-C30 and LC-13 questionnaires. Higher scores indicate better functioning and global health status/quality of life (GHS/QoL), or worse symptom severity. Repeated-measures analyses were performed to compare overall change from baseline scores between treatment arms, while controlling for baseline characteristics. Time to definitive clinically meaningful deterioration (TTDD) was analysed using a stratified log-rank test and a Cox proportional hazards model.
Results
A statistically significant difference in overall change from baseline in GHS/QoL favouring cemiplimab vs chemotherapy was observed in the two histology subgroups (squamous: 4.32, 95% CI [0.55,8.08], P=0.0247; non-squamous: 5.12, 95% CI [1.39,8.86], P=0.0073). In both histology subgroups, a statistically significant overall change from baseline favouring cemiplimab was found in physical and social functioning; fatigue, nausea/vomiting and appetite loss (QLQ-C30); and peripheral neuropathy and alopecia (QLQ-LC13). In both subgroups, a statistically significant delay in TTDD favouring cemiplimab was observed in social functioning, nausea/vomiting and appetite loss (QLQ-C30), peripheral neuropathy and alopecia (QLQ-LC13). When comparing between arms, no analyses yielded statistically significant PRO favouring chemotherapy for any QLQ-C30 or QLQ-LC13 scale.
Conclusions
In aNSCLC with PD-L1 ≥50%, cemiplimab resulted in significant benefits over chemotherapy in overall change from baseline and delayed TTDD across multiple cancer-related and lung cancer-specific PROs across both histology subgroups. PRO results further support the favourable benefit-risk profile of cemiplimab across both subgroups.
Clinical trial identification
NCT03088540.
Editorial acknowledgement
Medical writing support was provided by Rachel McGrandle, BSc, of 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. Sezer: Financial Interests, Institutional, Research Grant: Roche, Merck Sharp & Dohme, Merck Serono, AstraZeneca, Lilly, Novartis, Johnson & Johnson, Regeneron Pharmaceuticals, Inc., Sanofi. M. Gumus: Financial Interests, Personal, Other, Honoraria: Roche, Merck Sharp & Dohme, Gen İlaç, Novartis. M. Ozguroglu: Financial Interests, Personal, Other, honoraria: Novartis, Roche, Janssen, Sanofi, Astellas; Financial Interests, Personal, Advisory Board: Janssen, Sanofi, Astellas; Financial Interests, Personal, Other, travel support: Bristol-Myers Squibb, Janssen, AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca. X. He: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. G. Gullo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. P. Rietschel: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. R. Quek: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.