Merck announces results from Phase 3 Litespark-022 trial

Merck (MRK), known as MSD outside of the United States and Canada, announced the presentation of results from the Phase 3 Litespark-022 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with Welireg, given in the adjuvant setting, for patients with clear cell renal cell carcinoma 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 Cancers Symposium and are included in the official ASCO GU Press Program. At the first pre-specified interim analysis, Keytruda plus Welireg given in the adjuvant setting significantly improved disease-free survival, the study’s primary endpoint, reducing the risk of disease recurrence or death by 28% compared to Keytruda plus placebo. Median DFS was not reached in either arm; the estimated 24-month DFS rate was 80.7% for the Keytruda plus Welireg arm and was 73.7% for the Keytruda plus placebo arm. As previously reported, the trial will continue to evaluate overall survival, a key secondary endpoint.