Merck Phase 3 Kidney Cancer Trial Met Primary Endpoint

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from LITESPARK-005, the first positive Phase 3 trial investigating WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies. In the trial, WELIREG showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee. 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. The safety profile of WELIREG in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and shared with regulatory authorities.

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