In a prespecified interim analysis of the phase III LITESPARK-005 trial, Welireg, Merck’s oral hypoxia-inducible factor-2 alpha inhibitor, showed a statistically significant and clinically meaningful improvement in progression-free survival compared to Afinitor (everolimus) in adult patients with advanced renal cell carcinoma that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor therapies.
FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
