Reported Saturday, Merck And Eisai Present Late-Breaking ASCO GU Data, WELIREG Plus LENVIMA Delivers Statistically Significant PFS Benefit With HR 0.70 And 30% Risk Reduction Vs Cabozantinib, With FDA Review Accepted

This is the first positive Phase 3 trial of a HIF-2 alpha inhibitor in combination with a multi-targeted tyrosine kinase inhibitor, the first for patients with RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy, and the first to improve PFS compared to a modern tyrosine kinase inhibitor

Based on these data, the U.S. FDA has accepted for review two supplemental New Drug Applications for WELIREG plus LENVIMA in certain previously treated patients with advanced RCC