HiberCell Announces FPD in Clinical Collaboration with Merck, Evaluating HC-7366 in Combination with WELIREG® (belzutifan) in patients with ccRCC
Dec 14 (Reuters) - The U.S. Food and Drug Administration on Thursday approved Merck's (MRK.N) drug belzutifan for a type of kidney cancer.
Two months ago, when Merck revealed its phase 3 trial in renal cell carcinoma achieved its primary endpoint, as Welireg (belzutifan) racked up a decisive win over Novartis’ chemotherapy Afinitor in progression-free survival (PFS), there was disquieting side note.
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 LITESPARK-005 trial investigating WELIREG, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2?) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies. In the study, WELIREG demonstrated a statistically significant improvement in one of the trial’s dual primary endpoints of progression-free survival (PFS) and in a key secondary endpoint of objective response rate (ORR) compared to everolimus. These late-breaking data are being presented for the first time today during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2023 (abstract #LBA88) and are also being discussed with regulatory authorities worldwide.
FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)