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ESMO 2022 | Cohort 1 LITESPARK-003: belzutifan + cabozantinib 1L treatment for advanced RCC

Toni Choueiri, MD, Dana Farber Cancer Institute, Boston, MA, shares the results of cohort 1 of the Phase II LITESPARK-003 (NCT03634540) trial investigating belzutifan plus cabozantinib as first-line treatment of advanced renal cell carcinoma (RCC). The primary end point was confirmed objective response rate (ORR) and secondary end points were duration of response (DOR), progression-free survival (PFS), overall-survival (OS), and safety. ORR was 57%, median DOR was 28.6 months and median PFS was 30.3 months, with a manageable safety profile. Median OS was not reached.This interview took place at the European Society for Medical Oncology (ESMO) 2022 Congress in Paris, France.

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Transcript (edited for clarity)

LITESPARK-03 study cohort 1 deals with building on the HIF-2 inhibitor belzutifan. So untreated patient get belzutifan, the HIF-2 inhibitor, plus cabozantinib active first-line TKI. So this is a non-immunotherapy regimen. Response rate, we’re close to 60%, PFS 30 months, although with a short follow up. No patient had PD, and we did not have surprises at all for toxicity. There was no surprises...

LITESPARK-03 study cohort 1 deals with building on the HIF-2 inhibitor belzutifan. So untreated patient get belzutifan, the HIF-2 inhibitor, plus cabozantinib active first-line TKI. So this is a non-immunotherapy regimen. Response rate, we’re close to 60%, PFS 30 months, although with a short follow up. No patient had PD, and we did not have surprises at all for toxicity. There was no surprises. We knew what we knew about cabozantinib, what we knew about the HIF-2 inhibitor belzutifan. So this is quite an intriguing regimen. Belzutifan is being tested with another TKI lenvatinib in second-line, and in first-line also invetonib, belzutifan, but with pembrolizumab.

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