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
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