Welireg plus Keytruda cuts recurrence or death risk 28% in kidney cancer trial LITESPARK-022

Merck reported that adding Welireg to Keytruda reduced the risk of disease recurrence, metastasis or death by 28% versus Keytruda plus placebo in patients with earlier-stage clear cell kidney cancer at intermediate-high or high risk of recurrence. The FDA accepted the application for priority review with a June 19, 2026 target action date. A positive label would give Welireg its first earlier-stage kidney cancer indication and widen the use of Keytruda in the adjuvant setting.

• Hazard ratio 0.72 (95% CI 0.59 to 0.87; p=0.0003)
• 1,841 patients enrolled in LITESPARK-022
• FDA priority review; target action date June 19, 2026