Merck Reports Phase 3 LITESPARK-022 Win for Keytruda Plus Welireg in Adjuvant Kidney Cancer

Reuters02-28 23:05

Merck Reports Phase 3 LITESPARK-022 Win for Keytruda Plus Welireg in Adjuvant Kidney Cancer

Merck & Co. Inc. announced results from the Phase 3 LITESPARK-022 trial evaluating adjuvant pembrolizumab (KEYTRUDA) plus belzutifan (WELIREG) versus KEYTRUDA plus placebo in patients with clear cell renal cell carcinoma following nephrectomy. At the first pre-specified interim analysis (median follow-up 28.4 months), the combination significantly improved disease-free survival, with a hazard ratio of 0.72 (95% CI 0.59-0.87; p=0.0003) and estimated 24-month disease-free survival rates of 80.7% versus 73.7%. Merck said the data were presented for the first time at the 2026 ASCO Genitourinary Cancers Symposium, and that the FDA has accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX for adjuvant treatment of certain higher-risk RCC patients, with a target action date of June 19, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Merck & Co. Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202602281005BIZWIRE_USPR_____20260228_BW025853) on February 28, 2026, and is solely responsible for the information contained therein.

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Inc. announced results from the Phase 3 LITESPARK-022 trial evaluating adjuvant pembrolizumab (KEYTRUDA) plus belzutifan (WELIREG) versus KEYTRUDA plus placebo in patients with clear cell renal cell carcinoma following nephrectomy. At the first pre-specified interim analysis (median follow-up 28.4 months), the combination significantly improved disease-free survival, with a hazard ratio of 0.72 (95% CI 0.59-0.87; p=0.0003) and estimated 24-month disease-free survival rates of 80.7% versus 73.7%. 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Inc. announced results from the Phase 3 LITESPARK-022 trial evaluating adjuvant pembrolizumab (KEYTRUDA) plus belzutifan (WELIREG) versus KEYTRUDA plus placebo in patients with clear cell renal cell carcinoma following nephrectomy. At the first pre-specified interim analysis (median follow-up 28.4 months), the combination significantly improved disease-free survival, with a hazard ratio of 0.72 (95% CI 0.59-0.87; p=0.0003) and estimated 24-month disease-free survival rates of 80.7% versus 73.7%. Merck said the data were presented for the first time at the 2026 ASCO Genitourinary Cancers Symposium, and that the FDA has accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX for adjuvant treatment of certain higher-risk RCC patients, with a target action date of June 19, 2026.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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