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Toni K. Choueiri, MD, highlights data from the phase 2 LITESPARK-003 trial, which were presented at the 2023 ESMO Congress.
In this video, Toni K. Choueiri, MD, highlights data from the phase 2 LITESPARK-003 trial (NCT03634540) exploring belzutifan plus cabozantinib in patients with clear cell renal cell carcinoma (cRCC), which he presented at the 2023 European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain. Choueiri is a professor of medicine at Harvard Medical School and an attending physician, director of the Genitourinary Oncology Disease Center, and director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute in Boston, Massachusetts.
Video Transcript:
What we did in the study I presented in LITESPARK-003 is combining belzutifan with cabozatinib, a potent VEGF TKI. We had 2 cohorts. Cohort 1, [previously] untreated patients, response rates 70%. Toxicity manageable with dose interruption and dose reduction, especially of cabozantinib. Every patient out of the 50 had tumor shrinkage, and 70% had responses defined by RESIST. Cohort 2 previously treated patients up to 2 lines of therapy, as long as they have a PD-1 inhibitor [or] PDL-1 inhibitor. We saw a response rate whether 1-line or 2-line, whether immunotherapy only or immunotherapy plus VEGF, around 30% cohort confirmed responses by investigator assessment. There was a progression-free survival around 14 months. Again, same range of toxicity. Intriguing results. And the progression-free survival in cohort 1 was around 30 months.
So, proof of concept 1, we can combine both drugs. Second, this was taken to a phase 3 [trial] that finished accrual. And third, there is a significant [antitumor] activity. So certainly, belzutifan seems to play well at least with a TKI.
This transcription has been edited for clarity.