75P - Patient-reported outcomes (PROs) of cemiplimab + chemotherapy in advanced non-small cell lung cancer (NSCLC): EMPOWER-lung 3 liver metastases subpopulation

Background

As part of key subgroup analyses of EMPOWER-lung 3 (NCT03409614), a double-blinded, randomized (2:1) phase 3 trial, an improvement in overall survival (OS) was observed with cemiplimab + chemotherapy (CEMI+CHEMO, n=47) vs placebo + chemotherapy (CHEMO, n=23) in patients with baseline liver metastases from advanced NSCLC (median OS: 14.4 vs 8.9 months; hazard ratio (HR): 0.61 (95% confidence interval (CI): [0.31, 1.20]). The safety results of patients with baseline liver metastases were generally similar to those of the overall study population. We conducted exploratory analyses to evaluate PROs within this subgroup of patients.

Methods

PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks) for the first 6 doses, and then at start of every third cycle, using the EORTC-QLQ-C30 and -QLQ-LC13 questionnaires. A mixed-effect model for repeated measures analysis was performed to compare CEMI+CHEMO vs CHEMO for all scales. Time to definitive clinically meaningful deterioration (TTD) was evaluated using Kaplan-Meier analysis and between-arm TTD comparisons were made using a log-rank test and proportional hazards model.

Results

Statistically significant delay in TTD was observed favouring CEMI+CHEMO over CHEMO for role functioning (HR: 0.28, 95% CI [0.10, 0.79]; p=0.011), cognitive functioning (0.18, [0.06, 0.55]; p=0.001), haemoptysis (<0.01, [<0.01, not calculable]); p=0.021), and alopecia (0.25, [0.09, 0.72]; p=0.007). When comparing between arms, no statistically significant differences between CEMI+CHEMO vs CHEMO in overall change from baseline across all C30 or LC13 scales were observed. No analyses yielded statistically significant PRO results favouring CHEMO vs CEMI+CHEMO for any C30 or LC13 scales.

Conclusions

Among patients with baseline liver metastases from advanced NSCLC, CEMI+CHEMO resulted in significant delay in TTD in role functioning, cognitive functioning, haemoptysis, and alopecia when compared with CHEMO. Overall change from baseline across all PROs were maintained. These PRO results further support the favourable benefit–risk profile of CEMI+CHEMO vs CHEMO in advanced NSCLC with baseline liver metastases.

Clinical trial identification

NCT03409614.

Editorial acknowledgement

Editorial support was provided by John G Facciponte, PhD, of Prime, Knutsford, UK.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc.

Funding

Regeneron Pharmaceuticals, Inc., and Sanofi.

Disclosure

A. Baramidze: Other, Personal, Other, Travel support: Regeneron Pharmaceuticals, Inc. C. Gessner: Financial Interests, Personal, Advisory Board: AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, GSK, Novartis, Merck Sharp & Dohme, Pfizer, Roche, Sanofi. A. Sezer: Financial Interests, Institutional, Funding: 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. X. He, G. Gullo, P. Rietschel, R. Quek: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.