Shots:

• The EC approval is based on the P-III EMPOWER-Lung 1 trial evaluating Libtayo (350mg- q3w- for 108 wks.) monothx. vs platinum doublet CT as 1L treatment in 710 patients in a ratio (1:1) with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells & without EGFR- ALK- or ROS1 aberrations
• Results: improvement in OS- 32% reduction in risk of death; mOS (22mos. vs 14mos.); 74% of patients join to Libtayo following disease progression on CT. The prespecified analysis was performed in 563 patients with PD-L1 expression of ≥50% & showed a 43% reduction in risk of death
• The therapy is now approved for 3 advanced cancers in the EU while EC has also approved the therapy for BCC

  | Ref: Regeneron | Image: The Print