Shots:

• The approval is based on P-III KEYNOTE-042 trial results assessing Keytruda (200mg- q3w) vs CT in 1274 patients in ratio (1:1) with 1L stage III whose tumors expressed PD-L1 with TPS ≥1% and who had not received prior systemic treatment for metastatic NSCLC
• P-III KEYNOTE-042 study results: @ TPS ≥1%- TPS ≥50% mOS (16.7- 20.0 vs 12.1- 12.2mos.); mPFS (5.4- 7.1 vs 6.5- 6.4mos.); DOR @≥12mos.- ≥18 mos. (47%- 42% vs 16%- 17%)- (26%- 25% vs 6%- 5%); ORR (27%- 39% vs 27%- 32%)  
• Keytruda (pembrolizumab) 100mg is an anti-PD-1 therapy involves blocking of the interaction between PD-1 and its ligands i.e PD-L1 & PD- L2 and is evaluated in 900 trial globally in oncology

Ref: Merck & Co | Image: Merck