LITESPARK-005 Study: Belzutifan for Metastatic Clear Cell Renal Cell Carcinoma

At ESMO 2023, a study unveiled Belzutifan's success in treating advanced kidney cancer, showing improved survival, response rates, and quality of life. Pending approval, it may benefit previously treated patients and holds promise for varied treatment settings.


Dr Laurence Albiges (on-camera comments) - Courtesy of

During ESMO 2023, an individual presented a study at the forefront of oncology research. The study, known as LITESPARK-005, focused on patients with advanced kidney cancer who had previously undergone unsuccessful therapy. The trial explored the effectiveness of Belzutifan, a first-in-class inhibitor, in treating clear cell renal cell carcinoma (RCC) by targeting the hypoxia-inducible factor.

This inhibitor, Belzutifan, works by impeding the dimerization of IF 2A, thereby blocking the downstream oncogenic pathway. The study enrolled over 700 patients and demonstrated positive outcomes. Primary results showed a significant increase in progression-free survival (PFS) and a substantial rise in the response rate compared to the standard treatment, everolimus.

The interim analysis indicated a promising trend in overall survival, although final conclusions were pending. The study highlighted a new safety profile due to the distinctive mechanism of action of Belzutifan. The most notable adverse events observed were manageable anemia, related to EPO synthesis, and hypoxia, connected to the drug's mechanism, both occurring in a small number of patients.

Notably, patient-reported outcomes favored Belzutifan, indicating an improvement in the quality of life. The study’s success in demonstrating enhanced PFS, response rates, and improved quality of life, coupled with a favorable safety profile, suggests a potential approval pending regulatory assessment. There are prospects for employing this agent in various settings, not only as a standalone treatment for previously treated patients but also in adjuvant and first-line settings in combination therapies.