Vijith Shetty, Professor and Consultant Medical Oncologist at KS Hedge Medical Academy, shared a post on LinkedIn:
“FDA Approves a New Adjuvant Standard for Clear Cell Renal Cell Carcinoma (ccRCC)
A major milestone in kidney cancer treatment has been achieved.
The FDA has approved the combination of belzutifan + pembrolizumab as adjuvant therapy for adults with clear cell renal cell carcinoma (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, including those who have undergone complete resection of metastatic lesions.
The approval is based on the phase 3 LITESPARK-022 trial, which demonstrated:
Key Efficacy Results
Disease-Free Survival (DFS) at 24 months:
- 75.2% with belzutifan + pembrolizumab
- 69.1% with pembrolizumab alone
28% reduction in the risk of disease recurrence or death
- Hazard Ratio (HR): 0.72 (95% CI, 0.59–0.87)
- P = .0003
Safety Highlights
Grade ≥3 treatment-related adverse events:
- 39.5% with the combination
- 19.5% with pembrolizumab alone
Treatment discontinuation due to adverse events:
- 10.8% vs 3.5%, respectively
- No new safety signals were identified, and the adverse event profile was consistent with the known safety profiles of both agents.
This is the first phase 3 trial to demonstrate a significant improvement over adjuvant pembrolizumab alone in resected high-risk ccRCC, introducing a promising new standard of care for patients at increased risk of recurrence.”
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