Regeneron’s Libtayo (cemiplimab) Receives EC’s Approval as 1L Treatment of Advanced PD-L1 Positive Non-Small Cell Lung Cancer
Shots:
- 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
Related News:- Regeneron Receives EMA’s CHMP Positive Opinion of Libtayo (cemiplimab) for Advanced PD-L1 Positive Non-Small Cell Lung Cancer
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
