Welireg extends PFS in advanced renal cell carcinoma
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Belzutifan prolonged PFS compared with everolimus for certain patients with advanced renal cell carcinoma, according to topline data released by the agent’s manufacturer.
Belzutifan (Welireg, Merck) is an oral hypoxia-inducible factor-2 alpha inhibitor. It is approved in the U.S. for treatment of adults with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors that do not require immediate surgery.
The randomized phase 3 LITESPARK-005 trial included 746 adults with renal cell carcinoma that progressed after PD-1/PD-L1 checkpoint inhibitor and VEGF tyrosine kinase inhibitor therapy, either in sequence or in combination.
Researchers randomly assigned patients to 120 mg oral belzutifan daily or 10 mg oral everolimus daily.
PFS and OS served as dual primary endpoints. Objective response rate, duration of response, and safety/tolerability served as secondary endpoints.
Results of a prespecified interim analysis conducted by an independent data monitoring committee showed statically significant improvements in PFS and ORR in the belzutifan group.
The difference in OS between groups had not reached statistical significance, but OS will be tested in a subsequent analysis.
The safety profile of belzutifan appeared consistent with that observed in prior studies.
Complete results of LITESPARK-005 will be presented at a medical meeting and shared with regulatory authorities, according to a Merck press release.
“Patients with advanced [renal cell carcinoma] face low survival rates, and for those whose cancer progresses following [PD-1/PD-L1] and VEGF-TKI therapies, there is a need for new treatment options that can reduce their risk [for] disease progression or death,” Marjorie Green, MD, senior vice president and head of late-stage oncology development with Merck, said in the release. “This is the first phase 3 trial to show positive results in advanced [renal cell carcinoma] following these therapies and the first new mechanism to demonstrate potential in advanced [renal cell carcinoma] in recent years.”
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