The FDA has approved belzutifan (Welireg) in combination with pembrolizumab (Keytruda) for adults with clear cell renal cell carcinoma (ccRCC) who are at intermediate-high or high risk of recurrence after kidney cancer surgery.
The approval is based on results from the phase 3 LITESPARK-022 trial, which enrolled 1,841 patients. The study compared belzutifan plus pembrolizumab with pembrolizumab alone following surgery. The combination reduced the risk of cancer recurrence or death by 28%.
More patients remained cancer-free with the combination therapy. At 24 months, 80.7% of patients receiving belzutifan plus pembrolizumab were disease-free, compared with 73.7% of those receiving pembrolizumab alone. Overall survival data are still immature, but early results favor the combination.
The combination was associated with more side effects than pembrolizumab alone. Serious treatment-related adverse events occurred in 42% of patients versus 18% with pembrolizumab alone. Common side effects included anemia, fatigue, elevated liver enzymes, dizziness, and shortness of breath. However, treatment-related deaths were rare and similar in both groups.
The new regimen offers a promising option to reduce the risk of kidney cancer recurrence in patients with high-risk disease following surgery.