Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from the pivotal Phase 3 LITESPARK-022 trial evaluating 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, for patients with clear cell renal cell carcinoma (RCC) following nephrectomy. These late-breaking data will be presented for the first time today during an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA418) and are included in the official ASCO GU Press Program.
At the first pre-specified interim analysis (median follow-up of 28.4 months [range, 15.0-40.1 months]), KEYTRUDA plus WELIREG given in the adjuvant setting significantly improved disease-free survival (DFS), the study’s primary endpoint, reducing the risk of disease recurrence or death by 28% (HR=0.72 [95% CI 0.59-0.87]; p=0.0003) compared to KEYTRUDA plus placebo. Median DFS was not reached in either arm; the estimated 24-month DFS rate was 80.7% (95% CI, 77.7-83.2) for the KEYTRUDA plus WELIREG arm and was 73.7% (95% CI, 70.6-76.6) for the KEYTRUDA plus placebo arm. As previously reported, the trial will continue to evaluate overall survival (OS), a key secondary endpoint.
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