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Live In Play®

Updated: 13-Dec-24 07:07 ET

MRK: Merck receives positive EU CHMP opinion for WELIREG as treatment for adult patients with certain types of Von hippel-lindau disease-associated tumors and for certain previously treated adult patients with advanced renal cell carcinoma (101.25)

The treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localized renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, and for whom localized procedures are unsuitable;
The treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 inhibitor and at least two vascular endothelial growth factor targeted therapies.
Patients enrolled in LITESPARK-004 had other VHL-associated tumors, including CNS hemangioblastomas and pNET. In patients with VHL-associated CNS hemangioblastomas (n=24) in this trial, WELIREG showed an ORR of 63% (95% CI, 41-81) (n=15/24), with a complete response (CR) rate of 4% (n=1/24) and a PR rate of 58% (n=14/24). Median DOR for these patients was not reached, with ongoing responses ranging from 3.7+ to 22+ months; among responders, 73% (n=11/15) maintained a response for at least 12 months. In patients with VHL-associated pNET (n=12) in this trial, WELIREG showed an ORR of 83% (95% CI, 52-98) (n=10/12), with a CR rate of 17% (n=2/12) and a PR rate of 67% (n=8/12). Median DOR for these patients was not reached, with ongoing responses ranging from 11+ to 19+ months; among responders, 50% (n=5/10) maintained a response for at least 12 months.

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