Regeneron’s Libtayo (cemiplimab) Receives EC’s Approval as 1L Treatment of Advanced PD-L1 Positive Non-Small Cell Lung Cancer
- The EC has approved Libtayo in combination with Pt-based CT for adult patients with advanced NSCLC with ≥1% PD-L1 expression & with no EGFR, ALK, or ROS1 aberrations
- The approval was based on the P-III trial (EMPOWER-Lung 3) evaluating Libtayo (350mg) + Pt-doublet CT vs Pt doublet CT alone in a ratio (2:1) in 466 patients which showed improvements across 1EPs & 2EPs incl. OS, 70% expressing PD-L1 ≥1%, m-OS (22 vs 13mos.) representing a 45% relative reduction in risk of death, m-PFS (9 vs 6mos.), ORR (48% vs 23%), m-DoR (16 vs 5mos.)
- Permanent treatment discontinuation due to AEs (5%) & the trial's primary analysis results were published in Nature Medicine. Libtayo was approved in the EU & other countries for advanced BCC, CSCC, NSCLC & cervical cancer
Ref: Regeneron | Image: Regeneron
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