Kura Oncology’s Darlifarnib-Cabozantinib Combo Yields 44% ORR and 94% DCR in RCC
Subset analysis of 16 cabozantinib-pretreated ccRCC patients in the FIT-001 trial showed a 44% objective response rate and 94% disease control rate with darlifarnib plus cabozantinib, with tumor shrinkage observed in 75% of patients and reductions of 32–47%. Treatment durations reached up to 56 weeks, with one-third of patients still on therapy and a manageable safety profile.
1. Clinical efficacy in cabozantinib-pretreated ccRCC
Data from 16 ccRCC patients previously treated with cabozantinib in FIT-001 showed a 44% objective response rate and a 94% disease control rate with darlifarnib plus cabozantinib, achieving tumor shrinkage in 75% of participants with reductions of 32–47%.
2. Durability and safety profile
Treatment durations ranged from 8 to 56 weeks, with one-third of patients remaining on therapy at data cutoff, and the combination exhibited a manageable safety profile across multiple dose levels, including full-dose cabozantinib.
3. Phase 1b expansion and development plans
The study has advanced into a Phase 1b dose-expansion cohort to determine the optimal biologically active dose of darlifarnib (3–8 mg alternating schedule) combined with 40–60 mg cabozantinib, enrolling patients with prior immunotherapy to further assess benefit in refractory RCC.