FDA Approves Welireg + Keytruda Combo for Adjuvant Kidney Cancer

The FDA approved belzutifan (Welireg, Merck) in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the adjuvant treatment of adults with clear cell renal cell carcinoma (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The approval was based on LITESPARK-022, a randomized, double-blind trial in 1,841 patients showing a statistically significant improvement in disease-free survival (HR 0.72, 95% CI 0.59-0.87, P=.0003) for belzutifan plus pembrolizumab versus placebo plus pembrolizumab. Belzutifan is a first-in-class HIF-2alpha inhibitor originally approved for von Hippel-Lindau disease-associated tumors and advanced RCC; this adds an adjuvant indication aimed at preventing recurrence after surgery.