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

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.