Regeneron Receives EMA’s CHMP Positive Opinion of Libtayo (cemiplimab) for Advanced PD-L1 Positive Non-Small Cell Lung Cancer
- The EMA’s CHMP has adopted a positive opinion of Libtayo + Pt-based CT for advanced NSCLC with ≥1% PD-L1 expression. The EC’s final decision is expected in the coming months
- The opinion was based on the P-III trail (EMPOWER-Lung 3) evaluating Libtayo + Pt-doublet CT vs Pt-doublet CT alone in 466 patients with LA or metastatic NSCLC, sq. or non-sq. histologies across all PD-L1 expression levels with no ALK, EGFR, or ROS1 aberrations
- The trial showed an improvement in OS in the overall population, m-OS (22 vs 13mos.) with a median follow-up of 16mos., 45% relative reduction in risk of death, and survival benefit was observed with a median duration of follow-up of 28mos., AEs (25%) of patients and permanent discontinuation due to AEs in 5% of patients
Ref: Regeneron | Image: Regeneron
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