Shots:

• The sBLA is based on the P-III trial evaluating Libtayo + Pt-doublet CT vs CT alone in 466 patients with LA or metastatic NSCLC regardless of PD-L1 expression level or tumor histology with no ALK, EGFR, or ROS1 aberrations. The FDA’s decision is expected on Sept 19, 2022.
• The results showed an improvement in OS, treatment discontinuations due to AEs (5% & 3%), patients with immune-mediated AEs & ECOG 1 (19% & 84%), 43% & 67% had tumors with sq. histology & <50% PD-L1 expression, 15% not eligible for chemoradiation & 7% had clinically stable brain metastases
• Libtayo is approved in the US & EU as a monothx. for patients with ≥50% PD-L1 expression

Ref: Regeneron | Image: Barron's