Shots:

• The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg- q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR- ALK or ROS1 aberrations
• The study showed a 32% reduction in the risk of death; mOS (22mos. vs 14mos.); mPFS per BICR (6.2 vs 5.6mos.). An additional prespecified analysis was performed in 563 patients with proven PD-L1 expression of ≥50% and showed a 43% reduction in risk of death
• Libtayo is a fully human mAb targeting the immune checkpoint receptor PD-1 on T-cells. This approval marks the third approval in the US

 ­ Ref: GlobeNewswire | Image: STAT