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Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)
Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to chemotherapy alone TARRYTOWN, N.Y.,
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to chemotherapy alone\nTARRYTOWN, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) in combination with platinum-based chemotherapy. Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation. The European Commission is expected to make a final decision on the application in the coming months. In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression. The positive opinion is supported by results from the global Phase 3 EMPOWER-Lung 3 trial, which was designed to closely resemble a patient population with varied disease presentations that physicians manage in everyday clinical practice. At the primary analysis with a median follow-up of 16 months, the trial showed a statistically significant improvement in overall survival (OS) for patients treated with the Libtayo combination (n=312) compared to chemotherapy alone (n=154) in the overall population (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.53 to 0.93). Among the 466 patients enrolled in the trial, 70% of patients (n=327) had tumors expressing PD-L1 ≥1%. Comparing the Libtayo combination (n=217) to chemotherapy alone (n=110), efficacy results in this population showed a: 22-month versus 13-month median OS with a median follow-up of 16 months. This represented a 45% relative reduction in the risk of death in the trial (HR: 0.55; 95% CI: 0.39 to 0.78).Continued clinically meaningful survival benefit with a median duration of follow-up of 28 months (HR: 0.51; 95% CI: 0.38 to 0.69). Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo. Among those measu...