334P - Patient-reported outcomes with cemiplimab versus chemotherapy in advanced non-small cell lung cancer (aNSCLC): Geographic region subgroups in EMPOWER-Lung 1

Background

Previously reported subgroup analysis of EMPOWER-Lung 1 (NCT03088540), a randomised 1:1 open-label Phase 3 study, showed overall survival improvement trends with cemiplimab monotherapy (CEMI, n=283) versus platinum-doublet chemotherapy (CHEMO, n=280) in geographic region subgroups (Europe: hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.39–0.77; Asia: HR 0.76, 95% CI 0.24–2.41; rest of world [ROW]: HR 0.59, 95% CI 0.26–1.33) in patients with aNSCLC and programmed cell death-ligand 1 (PD-L1) ≥50%. With post-hoc exploratory analyses, patient-reported outcomes (PROs) were also evaluated in these three subgroups.

Methods

PROs were assessed at baseline and Day 1 of each treatment cycle for the first 6 cycles, then on Day 1 of every third cycle using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer Module (QLQ-LC13) questionnaires. Mixed-model for repeated measures analyses compared overall change from baseline scores between the two treatment arms while controlling for baseline characteristics.

Results

Baseline PRO scores were broadly similar between treatment arms across geographical regions. A statistically significant difference in overall change from baseline in global health status/quality of life favoured CEMI versus CHEMO in two subgroups (Asia: 12.61, 95% CI 4.44–20.77, P=0.0032; ROW: 9.09, 95% CI 0.89–17.29, P=0.0305). CEMI led to statistically significant favourable differences in all three subgroups in nausea/vomiting and constipation symptoms and in Europe and Asia subgroups in physical and role functioning, fatigue, and appetite loss symptoms per QLQ-C30, and alopecia per QLQ-LC13. When comparing between treatment arms, no analyses yielded statistically significant PRO results favouring CHEMO on any QLQ-C30 or QLQ-LC13 scale.

Conclusions

In patients with aNSCLC and PD-L2 ≥50% across three geographic region subgroups, CEMI led to significant overall improvement in multiple patient-reported cancer-related and lung cancer-specific functions and symptoms. Positive PRO results further support the favourable benefit-risk profile of CEMI versus CHEMO across these subgroups.

Clinical trial identification

NCT03088540.

Editorial acknowledgement

Medical writing support was provided by Daniel M Himmel, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Responsibility for all opinions, conclusions, and data interpretation lies with the authors.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc., and Sanofi.

Funding

Regeneron Pharmaceuticals, Inc., and Sanofi.

Disclosure

G.F. Ho: Financial Interests, Personal, Advisory Board: AstraZeneca. A. Sezer: Financial Interests, Personal, Research Grant: Roche, Merck Sharp & Dohme, Merck Serono, AstraZeneca, Lilly, Novartis, Johnson & Johnson, Regeneron Pharmaceuticals, Inc., and Sanofi. M. Gumus: Financial Interests, Personal, Advisory Role: Roche, Merck Sharp & Dohme, Gen İlaç and Novartis. M. Ozguroglu: Financial Interests, Personal, Advisory Role: Novartis, Roche, Janssen, Sanofi and Astellas; Financial Interests, Personal, Advisory Board: Janssen, Sanofi and Astellas; Financial Interests, Personal, Other, travel support: Bristol Myers Squibb, Janssen and AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca. X. He, G. Gullo, P. Rietschel, R.G. 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.