Abstract
INTRODUCTION: Patients with unresectable locally advanced NSCLC who are not candidates for concurrent chemoradiation represent an unmet medical need. We report long-term results for this patient subgroup from two phase III trials. METHODS: We analyzed data from patients with locally advanced NSCLC in the EMPOWER-Lung 1 (NCT03088540) and EMPOWER-Lung 3 (NCT03409614) studies. In EMPOWER-Lung 1, patients were randomized 1:1 to first-line (1L) cemiplimab monotherapy or chemotherapy with more than or equal to 50% programmed death-ligand 1 expression. In EMPOWER-Lung 3, patients were randomized 2:1 to 1L cemiplimab plus chemotherapy or chemotherapy, regardless of programmed death-ligand 1 expression. RESULTS: Patients with locally advanced NSCLC constituted 15% of the overall study populations. With cemiplimab monotherapy, the overall survival (OS) was improved versus chemotherapy (median 26.1 versus 13.9 mo; hazard ratio [HR]: 0.67, 95% confidence interval [CI]: 0.38-1.17) and progression-free survival (8.1 versus 6.2 mo; HR: 0.56, 95% CI: 0.34-0.95). With cemiplimab plus chemotherapy, the OS was improved versus chemotherapy alone (24.1 versus 13.8 mo; HR: 0.50, 95% CI: 0.27-0.95) and progression-free survival (12.5 versus 6.2 mo; HR: 0.34, 95% CI: 0.19-0.61). Treatment-emergent adverse events grade more than or equal to 3 occurred in 37.8% (cemiplimab) and 53.7% (chemotherapy) in EMPOWER-Lung 1 and in 46.7% (cemiplimab plus chemotherapy) and 25.0% (chemotherapy) in EMPOWER-Lung 3. Favorable patient-reported outcomes were observed with cemiplimab monotherapy than chemotherapy; no significant patient-reported outcomes favoring chemotherapy were observed in either study. CONCLUSIONS: This subgroup analysis supports the clinical benefit of 1L cemiplimab as monotherapy or combined with chemotherapy in patients with unresectable locally advanced NSCLC (not candidates for definitive chemoradiotherapy).