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Merck Announces KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Clear Cell Renal Cell Carcinoma (RCC) Following Nephrectomy
RAHWAY, N.J.,, October 28, 2025--Merck Announces KEYTRUDA Plus WELIREG Met Primary Endpoint of DFS in Certain Patients With Clear Cell Renal Cell Carcinoma (RCC) Following Nephrectomy
About this update from Merck & Company, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/dac131cff62a97f583131d056068eab1"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/h3LnXzFS.oPbYI1h45TGaA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/dac131cff62a97f583131d056068eab1","width":480,"height":217}},"lazy":false},{"type":"text","content":"First combination regimen to demonstrate improvement in DFS compared to KEYTRUDA monotherapy for these patients in the adjuvant setting","length":135,"tagName":"p","attribs":{}},{"type":"text","content":"LITESPARK-022 is the second positive Phase 3 study for WELIREG as part of a combination regimen in RCC","length":102,"tagName":"p","attribs":{}},{"type":"text","content":"RAHWAY, N.J.,, October 28, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint.","length":779,"tagName":"p"},{"type":"text","content":""KEYTRUDA monotherapy given in the adjuvant setting remains an important treatment choice for patients with renal cell carcinoma at an increased risk of recurrence following surgery and is the only approved option to have significantly improved disease-free survival and overall survival in this disease setting. Still, many of these patients do remain at risk of recurrence and continue to represent an unmet need," said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. "These encouraging results of KEYTRUDA in combination with WELIREG from LITESPARK-022 demonstrate the potential to p...