Shots:

• The approval is based on P-III KEYNOTE-426 study assessing Keytruda (200mg) + Inlyta (5mg) vs Sunitinib (50mg) in 861 patients in a ratio (1:1) with advanced RCC regardless of PD-L1 tumor expression and IMDC risk group
• The P-III KEYNOTE-426 study results: improvement in OS- 47% reduction in risk of death- m-PFS (15.1 vs 11.0 mos.); ORR (59% vs 36%); CRR (6% vs 2%); PRR (53% vs 34%). The approval allows marketing of Keytruda dual regimen in all 28 EU member states + Iceland- Lichtenstein and Norway
• KEYTRUDA is an anti-PD-1 therapy- act blocking the interaction between PD-1 and its ligands- PD-L1 and PD-L2 thus activating T lymphocytes affecting both tumor and healthy cells and is the first anti-PD-1 therapy to be approved in EU as combination therapy for RCC across all IMDC risk groups

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Ref: Business Wire | Image: Merck