Pivotal study supports belzutifan approval for patients with advanced kidney cancer
Belzutifan is a hypoxia-inducible factor 2 Alpha inhibitor that has showed clinical activity in clear-cell renal-cell carcinoma in early-phase studies.
The LITESPARK-005 phase 3 clinical enrolled 746 patients with metastatic clear cell renal cell carcinoma (ccRCC) who had progressed after treatment with both an immune checkpoint inhibitor (ICI) and an anti-angiogenic therapy. Patients were randomized to receive treatment with either belzutifan, a HIF-2α inhibitor, or everolimus. Overabundant HIF-2α is associated with increased cancer-driving activity.
At the second interim analysis of this study, after a median of 25.7 months, patients taking belzutifan were 25% less likely to have progressed compared with those taking everolimus. Results were presented at the annual European Society for Medical Oncology (ESMO) Congress in 2023 and are now published in the New England Journal of Medicine.
Belzutifan showed a significant benefit over everolimus with respect to progression-free survival and objective response in participants with advanced clear-cell renal-cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies. Belzutifan was associated with no new safety signals.
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