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

Objective:

To report the FDA approval of pembrolizumab and belzutifan as adjuvant treatment for higher-risk clear cell renal cell carcinoma (ccRCC) post-surgery.

Approach:

Study Design: The phase 3 LITESPARK-022 trial involved 1,841 participants with ccRCC who underwent surgery and were at high risk of recurrence.
Treatment Comparison: Patients were randomized to receive either pembrolizumab plus belzutifan or pembrolizumab plus placebo after surgery.

Key Findings:

The combination therapy resulted in a 28% decrease in the risk of recurrence, metastasis, or death based on the trial results.
Approximately 81% of participants on the combination therapy were cancer-free after 24 months, compared to 74% on the placebo.

Interpretation:

This approval establishes pembrolizumab and belzutifan as a new adjuvant option for patients with ccRCC at increased risk of recurrence.

Limitations:

The study's follow-up period was a median of 28.4 months.
Side effects were consistent with data from previously reported studies.

Conclusion:

This is the first approval for belzutifan in earlier-stage ccRCC and the first for a PD-1 and HIF-2alpha inhibitor combination regimen.

Sources:

Dana-Farber Cancer Institute

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

Objective:

Approach:

Key Findings:

Interpretation:

Limitations:

Conclusion:

Sources:

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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