1853P - Risk model for overall survival (OS) based on composite patient-reported outcomes (PROs) in aNSCLC patients treated with first-line (1L) cemiplimab-based therapy

Background

PROs have shown promise as prognostic factors for OS. Risk modeling of OS based on single PRO scales was previously evaluated in pts with aNSCLC treated with 1L cemiplimab ± chemotherapy in 2 phase 3 trials. In this study, we further evaluate a risk model for OS based on composite PRO assessment.

Methods

Data from EMPOWER-Lung 1 (NCT03088540) and EMPOWER-Lung 3 (NCT03409614) were used to evaluate the association between baseline PRO burden and OS with a Cox proportional hazard model stratified by treatment, histology and PD-L1 level. Single-scale PROs (EORTC QLQ-C30 and LC13) were assessed using the HR for prognostic value; similarly, composite PRO endpoints (based on the combination of 1 functioning and 1 symptom scale) were assessed. PROs with higher HRs when comparing high vs low PRO burden are deemed to have higher risk of death.

Results

Top 10 composite PROs with the highest risk for death include combinations of functioning scales (social, role and physical) and select symptom scales (dyspnoea, appetite loss and pain from C30; dyspnoea and coughing from LC13) with nominal P-values

Conclusions

In pts with aNSCLC treated with 1L cemiplimab-based therapy, a risk model of OS using baseline PROs demonstrated greater prognostic value of composite PROs consisting of a functioning and symptom scale than relying on single PRO scales. These results suggest clinical utility of composite PROs for evaluating the risk of death; further development and analysis of composite PROs for clinical trials may be warranted.

Clinical trial identification

NCT03088540, NCT03409614.

Editorial acknowledgement

Medical writing support was provided by Qing Zhou, PhD, ELS, of Regeneron Pharmaceuticals, Inc.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc.

Funding

Regeneron Pharmaceuticals, Inc.

Disclosure

D.R. Gandara: Financial Interests, Institutional, Research Funding: Amgen, AstraZeneca, Genentech, Merck; Financial Interests, Personal, Speaker, Consultant, Advisor: AdaGene, AstraZeneca, Genentech, Guardant Health, IO Biotech, Oncocyte, OncoHost; Financial Interests, Personal, Financially compensated role: Lilly, Merck, Novartis; Financial Interests, Personal, Other, Travel: Guardant Health; Financial Interests, Personal, Advisory Board: Lilly, Merck, Novartis. A. Sezer: Financial Interests, Institutional, Research Funding: Roche, Merck Sharp & Dohme, Merck Serono, AstraZeneca, Lilly, Novartis, Johnson & Johnson, Regeneron Pharmaceuticals, Inc, Sanofi. M. Gumus: Financial Interests, Personal, Financially compensated role: Roche, Merck Sharp & Dohme, Gen İlaç, Novartis. E. Yan: Financial Interests, Personal, Full or part-time Employment: Cyan Global Inc; Financial Interests, Personal, Speaker, Consultant, Advisor: Regeneron. J. Harnett, P. Rietschel, R. Quek: Financial Interests, Personal, Full or part-time Employment: Regeneron; Financial Interests, Personal, Stocks/Shares: Regeneron. All other authors have declared no conflicts of interest.