Dana-Farber Research Supports FDA Approval of Pembrolizumab-Belzutifan Combination for Higher-Risk Clear Cell Kidney Cancer After Surgery

The U.S. Food and Drug Administration (FDA) has approved pembrolizumab, an immunotherapy, plus belzutifan, a HIF-2alpha inhibitor, as adjuvant treatment for adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, with or without resection of metastatic lesions.

By
June 12, 2026
3 min

Dana-Farber

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The FDA approved pembrolizumab plus belzutifan for adjuvant treatment of high-risk clear cell renal cell carcinoma after surgery.
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This approval is based on the phase 3 LITESPARK-022 trial, which included 1,841 participants with clear cell renal cell carcinoma.
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The combination therapy resulted in a 28% decrease in the risk of recurrence, metastasis, or death compared to pembrolizumab plus placebo.
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Approximately 81% of patients receiving the combination therapy were cancer-free after 24 months, compared to 74% with standard care.
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Belzutifan, a HIF-2alpha inhibitor, targets overabundant HIF-2alpha in clear cell renal cell carcinoma cells to reduce cancer progression.

Dana-Farber Research Supports FDA Approval of Pembrolizumab-Belzutifan Combination for Higher-Risk Clear Cell Kidney Cancer After Surgery

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Original Source(s)

Dana-Farber Research Supports FDA Approval of Pembrolizumab-Belzutifan Combination for Higher-Risk Clear Cell Kidney Cancer After Surgery

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