First-Line Cemiplimab Demonstrates Long-Term Efficacy Among Patients With Advanced Non-Small Cell Lung Cancer With PD-L1 ≥ 50%
According to 5-year follow-up results from the phase 3 EMPOWER-Lung 1 trial, first-line cemiplimab demonstrated continued efficacy compared to chemotherapy among patients with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50%.
In this study, researchers randomized 712 patients, including 565 with confirmed PD-L1 expression ≥ 50%, on a 1-to-1 basis to receive either 350 mg of cemiplimab once every 3 weeks for 2 years (n = 357) or investigator’s choice chemotherapy (n = 355). Primary end points included overall survival (OS) and progression-free survival (PFS). Key secondary end points included objective response rate (ORR) and safety.
At a median follow-up of 59.6 months, median OS was 26.1 months in the cemiplimab arm and 13.3 months in the chemotherapy arm. Median PFS was 8.1 months in the cemiplimab arm and 5.3 months in the chemotherapy arm. The ORR was 46.5% in the cemiplimab arm and 20.6% in the chemotherapy arm. The 5-year OS probability was 29% and 15%, respectively. Grade ≥ 3 treatment-related adverse events occurred in 18.3% of patients in the cemiplimab arm and 39.9% of patients in the chemotherapy arm.
As Dr Kilickap et al concluded, “First-line cemiplimab monotherapy continued to show durable clinical benefits versus chemotherapy in patients with advanced NSCLC with PD-L1 ≥50%.”
Source:
Kilickap S, Baramidze A, Sezer A, et al. Cemiplimab monotherapy for first-line treatment of patients with advanced NSCLC with PD-L1 expression ≥50%: 5-year outcomes of EMPOWER-Lung 1. J Thorac Oncol. Published online: March 18th, 2025. doi: 10.1016/j.jtho.2025.03.033
