Merck Reveals Mixed Results From Pivotal Kidney Cancer Study Of Welireg In Pretreated Patients

Merck & Co Inc MRK released topline results from LITESPARK-005, a Phase 3 trial investigating WELIREG (belzutifan), Merck's oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. 

LITESPARK-005 is evaluating WELIREG for adult patients with advanced renal cell carcinoma (RCC) who progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies. 

WELIREG showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to Novartis AG's NVS Afinitor (everolimus).

A statistically significant improvement in the trial's key secondary endpoint of objective response rate (ORR) was also demonstrated. A trend toward improvement in overall survival (OS), a dual primary endpoint, was observed; however, this result did not reach statistical significance. OS will be tested at a subsequent analysis. 

WELIREG was the first HIF-2α inhibitor therapy approved in the U.S. for von Hippel-Lindau (VHL) disease that requires therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery, based on ORR and duration of response data from the Phase 2 LITESPARK-004 trial. 

LITESPARK-005 is part of a comprehensive development program for WELIREG comprised of four Phase 3 trials in RCC, including LITESPARK-011 and LITESPARK-012, evaluating WELIREG in the second-line and treatment-naïve advanced disease settings, and LITESPARK-022, evaluating WELIREG in the adjuvant setting.

Price Action: MRK shares were up 0.19% at $109.09 during early trading on Friday.

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