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
Related News:- Regeneron’s Libtayo (cemiplimab) Receives the MHLW’s Approval for Advanced or Recurrent Cervical Cancer in Japan
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 [email protected].