Review of patient‐reported outcomes in EMPOWER‐Lung 1 in patients with advanced non‐small cell lung cancer treated with cemiplimab versus chemotherapy

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Abstract
Background: Patient‐reported outcomes (PROs) for cemiplimab monotherapy versus chemotherapy from the EMPOWER‐Lung 1 phase 3 clinical trial (ClinicalTrials.gov identifier NCT03088540) in patients who had advanced non‐small cell lung cancer with programmed cell death‐ligand 1 expression ≥50% were previously reported. Methods: This review article characterizes PRO findings for cemiplimab monotherapy versus chemotherapy overall and in prespecified subgroups of patients from the EMPOWER‐Lung 1 clinical trial. Patients were randomly assigned 1:1 to receive either cemiplimab 350 mg every 3 weeks or platinum‐doublet chemotherapy, and multiple PROs, including the European Organization for Research and Treatment of Cancer Quality of Life–Core 30 questionnaire, were administered in the EMPOWER‐Lung 1 trial. PRO analyses using mixed model for repeated measures analysis to estimate least‐squares mean changes in PRO scores from baseline and Cox proportional hazards models for the time to deterioration using a 10‐point threshold have been reported and are summarized herein. Results: Generally, the mixed model for repeated measures analysis of global health status/quality of life (GHS/QoL) significantly favored cemiplimab versus chemotherapy in the overall study population and in prespecified subgroup populations. Statistically significant differences in the overall change from baseline in GHS/QoL favoring cemiplimab versus chemotherapy were observed overall and in multiple subgroups, including patients who had brain metastasis ( p = .0110), an Eastern Cooperative Oncology Group performance status of 1 ( p = .0017), squamous ( p = .0247) and nonsquamous ( p = .0073) histology, and patients aged 65 years and older ( p = .0069). Statistically significant delays in the time to deterioration favoring cemiplimab were observed in GHS/QoL for the subgroup with programmed cell death‐ligand 1 expression ≥90% ( p = .0152) and the subgroup younger than 65 years ( p = .0195). Conclusions: Collectively, the current data support the GHS/QoL benefit of first‐line cemiplimab monotherapy versus chemotherapy overall and in multiple subpopulations of patients with programmed cell death‐ligand 1 expression ≥50% advanced non‐small cell lung cancer.

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