Keytruda–Welireg Combination Shows Promise in RCC Phase III Trial

Merck & Co. (known as MSD outside the US) has reported positive results from the Phase III LITESPARK‑022 trial evaluating a combination of Keytruda (pembrolizumab) and Welireg (belzutifan) as adjuvant therapy for patients with clear cell renal cell carcinoma following nephrectomy.

The multicentre, randomised, double-blind study enrolled 1,841 patients. Participants received either Welireg (120 mg orally once daily) plus Keytruda (400 mg intravenously every six weeks) for about one year, or Keytruda with placebo.

At the first interim analysis after 28.4 months of median follow-up, the combination reduced the risk of disease recurrence or death by 28%, meeting the primary endpoint of disease-free survival (DFS). The estimated 24-month DFS rate was 80.7% with the combination versus 73.7% with Keytruda alone.

Safety findings were consistent with earlier studies, and no new safety concerns emerged. The U.S. Food and Drug Administration has granted priority review for the combination therapy.

06-03-2026