Phase 1a FIT-001 data showed 13-month median progression-free survival in pretreated, cabozantinib-naïve advanced clear cell renal cell carcinoma, while a randomized Phase 1b study is underway to select a Phase 3 dose.
Kura Oncology reported updated Phase 1a results from the ongoing FIT-001 trial showing encouraging activity for darlifarnib plus cabozantinib in cabozantinib-naïve patients with advanced clear cell renal cell carcinoma. In 34 evaluated patients, objective response rates ranged from 33% to 50% across darlifarnib dose levels and median progression-free survival (time patients live without disease worsening) was 13 months across pooled dose levels. Median duration of response was not estimable at most dose levels because multiple responses were still ongoing, and more than half of patients remained on treatment at the data cut-off. In 72 RCC patients assessed for safety, the company said the combination was manageable and generally consistent with the known profiles of the individual agents, with neutropenia managed through dose interruption, dose reduction and supportive care after the initial dose-limiting toxicity period. The data were presented at the 2026 Kidney Cancer Research Summit in Boston. Kura said the findings support continued development of the regimen, including an ongoing randomized Phase 1b study in the U.S. and E.U. comparing darlifarnib plus cabozantinib against cabozantinib alone to determine a recommended Phase 3 dose for a planned registrational study in 2028.