FP04.03 Clinical Benefit of First-Line Cemiplimab in Patients with Locally Advanced NSCLC: Subgroup Analysis from EMPOWER-Lung 1

Abstract

Agents which inhibit the programmed death receptor-1 (anti–PD-1) have transformed treatment for patients with metastatic non-small cell lung cancer (NSCLC), however there is paucity of prospective clinical data investigating the use of these agents in patients with locally advanced NSCLC (laNSCLC) who are not candidates for definitive concurrent chemoradiotherapy. In the Phase 3 EMPOWER-Lung 1 Study (NCT03088540), cemiplimab, a PD-1 inhibitor, demonstrated improved overall survival (OS) and progression-free survival (PFS) in patients with advanced NSCLC and programmed cell death-ligand 1 (PD-L1) expression in ≥50% of tumor cells vs platinum-doublet chemotherapy. This study allowed the enrollment of patients with laNSCLC, in addition to those with metastatic disease, providing the largest prospective randomized evidence of first-line (1L) anti–PD-1 monotherapy in this patient population. Here, we present a post-hoc subgroup analysis of patients with laNSCLC from the PD-L1 ≥50% population in EMPOWER-Lung 1. In EMPOWER-Lung 1, patients were randomized 1:1 to cemiplimab 350 mg intravenous every 3 weeks or investigator’s choice of platinum-doublet chemotherapy. Patients with laNSCLC were those with stage 3B/3C disease who were not candidates for definitive concurrent chemoradiotherapy. Data cut-off for this subgroup analysis was March 1, 2020. In the PD-L1 ≥50% population of EMPOWER-Lung 1 (n=563), 87 (15.5%) patients had laNSCLC; cemiplimab (n=45) and chemotherapy (n=42). In the total laNSCLC population (n=87), median (range) age was 63.0 (31.0–81.0); male: 86.2%; non-squamous histology: 36.8%; stage 3B cancer: 79.3%; and stage 3C cancer: 20.7%. At a median follow-up of 11.6 months (interquartile range 7.2–18.2 months), cemiplimab provided significantly better PFS vs chemotherapy and numerically longer OS (not reaching statistical significance) (see Table). Objective response rates (ORR) and Kaplan–Meier estimated median duration of response (DOR) were also numerically improved with cemiplimab vs chemotherapy. In patients with laNSCLC and with PD-L1 ≥50%, 1L cemiplimab monotherapy demonstrated a significant improvement in PFS, numerically longer OS, and numerically better ORR and DOR vs chemotherapy. These results support clinical benefit provided by cemiplimab 1L monotherapy for patients with laNSCLC with PD-L1 ≥50%.