Regeneron’s Libtayo (cemiplimab-rwlc) Receives the US FDA’s Approval as 1L Treatment for Advanced Non-small Cell Lung Cancer
Shots:
- The approval was based on the P-III (EMPOWER-Lung 3) trial evaluating Libtayo (350mg, IV, q3w) + Pt-doublet CT vs CT alone in a ratio (2:1) in 466 patients with LA or metastatic NSCLC irrespective of PD-L1 expression or tumor histology with no ALK, EGFR or ROS1 aberrations
- The results showed an improvement in OS, m-OS & m-PFS was (22 vs 13mos.) & (8 vs 5mos.) with 29% & 44% relative reduction in risk of death & disease progression; 12mos. probability of survival (66% vs 56% & 38% vs 16%), no new Libtayo safety signals were reported
- The therapy showed an ORR (43% vs 23%), m-DoR (16 vs 7mos.), serious AEs were reported in 25% & AEs also lead to treatment discontinuations in 5%
Ref: PRNewswire | Image: Regeneron
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.
