LITESPARK-013: Dose Comparison of Belzutifan in Advanced RCC

Jaime Merchan, MD, professor, co-leader of the Translational and Clinical Oncology Research Program and director of the phase 1 clinical trials program at the Sylvester Comprehensive Cancer Center at the University of Miami, discusses the background and findings from the LITESPARK-013 trial (NCT04489771) which evaluated belzutifan (Welireg), a hypoxia-inducible factor (HIF)–2α inhibitor, in patients with advanced clear cell renal cell carcinoma.

Transcription:

0:09 | LITESPARK-013 was a randomized, phase 2 trial comparing 2 different dose levels of belzutifan, a novel HIF–2α blocker in patients with clear cell renal cell carcinoma. The objectives of the study were to try to determine the differences in the efficacy between the 2 doses, the standard dose of 120 mg per day vs the high dose of 200 mg per day.

0:39 | The results of the study presented last year at [the 2023 European Society of Medical Oncology Annual Meeting] showed that both the low and the high doses of belzutifan were associated with similar efficacy with similar response rates and also no significant differences in a median progression-free survival, suggesting that both doses were effective and probably that the lower dose of 120 [mg], which is the standard dose, is enough to induce clinical benefit.

1:14 | The current study, [that was] presented at [the American Society of Clinical Oncology] 2024 [Annual Meeting], is a post hoc efficacy analysis conducted on a pooled population. The analysis included both low- and high-dose treated patients to explore potential correlations between efficacy and various clinical factors. These factors included differences in IMBC scores, differentiation status, the number of prior lines of therapy (one or more), and the type of first-line therapy administered, such as [tyrosine kinase inhibitors] or checkpoint inhibitors.

REFERENCE:

Ghatalia P, Agarwal N, Brugarol J, et al. LITESPARK-013: Randomized phase 2 study of two doses of belzutifan in patients with advanced clear cell renal cell carcinoma (ccRCC). Presented at: 2023 International Kidney Cancer Symposium; November 9-11, 2023. Accessed November 10, 2023. Abstract 33.