Regeneron Pharmaceuticals announced positive five-year results from the phase 3 EMPOWER-Lung 1 trial, demonstrating durable survival benefits for Libtayo (cemiplimab) in patients with advanced non-small cell lung cancer (NSCLC). The study compared Libtayo to chemotherapy as a first-line treatment in adults with at least 50% PD-L1 expression and without EGFR, ALK, or ROS1 aberrations.
The final pre-specified overall survival (OS) analysis, presented at this year’s World Conference on Lung Cancer, revealed a median OS of 26 months in the Libtayo treatment group, compared to 13 months in the chemotherapy cohort. The median progression-free survival for Libtayo was eight months, versus five months for chemotherapy. Patients receiving Libtayo also demonstrated an objective response rate of 46.5%, compared to 21% for chemotherapy.
Durable Benefits and Safety Profile
Continued and clinically meaningful benefits were observed at the five-year follow-up in the overall trial population, including those not confirmed to have at least 50% PD-L1 expression. No new safety signals were observed among evaluable patients during this period.
Expert Commentary
"The five-year results from EMPOWER-Lung 1 showcase the durable survival benefit and impressive efficacy of first-line Libtayo monotherapy compared to chemotherapy in patients with PD-L1 high, advanced NSCLC, including a direct correlation between survival benefits and PD-L1 expression level," said Ana Baramidze, head of clinical research department at Todua Clinic.
Lung Cancer Statistics and Libtayo's Role
Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC accounting for up to 85% of all diagnoses. Libtayo, a monoclonal antibody, blocks cancer cells from using the PD-1 pathway to suppress T-cell activation. It is already approved for certain NSCLC cases, both as a monotherapy and in combination with platinum-containing chemotherapy. The therapy is also authorized for treating cutaneous squamous cell carcinoma and basal cell carcinoma.
