Belzutifan and Cabozantinib in Renal Cell Carcinoma
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- April 17, 2023
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On March 31, 2023, Dr. Toni K. Choueiri and colleagues from the Dana-Farber Cancer Institute published the efficacy and safety results of a Phase 2 clinical trial (NCT03634540) in The Lancet Oncology. The study evaluated the combination of Belzutifan and Cabozantinib in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had previously received immunotherapy.
Study Design: This was an open-label, single-arm Phase 2 clinical trial enrolling 52 patients with ccRCC. Participants were treated with Belzutifan (120 mg once daily) and Cabozantinib (60 mg once daily) until disease progression or unacceptable toxicity occurred. The primary endpoint was the objective response rate (ORR).
Clinical Outcomes: At a median follow-up of 24.6 months, the results were as follows:
- Objective Response Rate (ORR): 30.8%.
- Complete Response (CR): 2% (N=1).
- Partial Response (PR): 29% (N=15).
Safety and Tolerability: The most common Grade 3–4 adverse event was hypertension, occurring in 27% of patients. The incidence of serious adverse events (SAEs) was 29%.
Conclusion: Based on the results of this Phase 2 trial, Dr. Toni K. Choueiri and the research team concluded that the combination of Belzutifan and Cabozantinib demonstrated promising anti-tumor activity in patients with advanced clear cell renal cell carcinoma who had previously undergone immunotherapy.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00097-9/fulltext
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