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European Commission Approves Libtayo in PD-L1-Positive Non-Small Cell Lung Cancer

NEW YORK – Regeneron Pharmaceuticals on Wednesday said that the European Commission approved Libtayo (cemiplimab) with platinum-based chemotherapy as a first-line therapy for patients with PD-L1-positive non-small cell lung cancer.

The decision was based on the Phase III EMPOWER-Lung trial, which showed that patients treated with Libtayo had improved overall survival and progression-free survival compared to placebo. In the trial, investigators enrolled 466 patients with locally advanced or metastatic NSCLC across all PD-L1 expression levels with no EGFR, ALK, or ROS1 aberrations. Patients were randomized to receive 350 mg of Libtayo or placebo intravenously every three weeks for 108 weeks, plus chemotherapy every three weeks for four cycles.

An independent data-monitoring committee recommended stopping the trial early when patients on Libtayo showed a significant improvement in overall survival in the overall patient population. Patients expressing PD-L1 at 1 percent or more who received Libtayo had a median overall survival of 22 months, compared to 13 months for chemotherapy alone. They also had a median progression-free survival of nine months versus six months for the placebo group.

The US Food and Drug Administration approved Libtayo with chemotherapy in this same setting in November 2022, and in March 2023, the agency approved Roche's Ventana PD-L1 assay as a companion diagnostic for Libtayo in lung cancer patients.

The drug is currently approved in the EU and some other countries for basal cell carcinoma, cutaneous squamous cell carcinoma, NSCLC, and cervical cancer.