The phase 3 LITESPARK-022 trial shows that combining Belzutifan (Welireg) with Pembrolizumab (Keytruda) after surgery significantly lowers the risk of recurrence in patients with high-risk clear cell renal cell carcinoma. The study found a 28% reduction in the risk of recurrence or death compared to Pembrolizumab alone. Overall survival data are still immature, though early trends favor the combination.
Benefits were seen across most patient groups, including those with intermediate-high risk and M1 NED status. Side effects, including anemia and occasional low oxygen levels, were manageable, with few patients needing to stop treatment.
Belzutifan is expected to become a key part of ccRCC therapy, moving from advanced disease into the adjuvant setting, but its benefits are currently limited to clear cell tumors. Oncologists are advised to learn how to manage its side effects as it enters early-stage care, while further data on overall survival and metastasis-free outcomes are awaited.