Kura Oncology (NASDAQ:KURA) today presented encouraging preliminary data from a subset analysis of its ongoing FIT-001 clinical trial at the 2026 International Kidney Cancer Symposium.
The study evaluated darlifarnib (KO-2806), a next-generation farnesyl transferase inhibitor, in combination with the tyrosine kinase inhibitor (TKI) cabozantinib for patients with advanced clear cell renal cell carcinoma (ccRCC).
The analysis focused on a particularly challenging patient population (N=16) that had previously progressed on cabozantinib therapy.
In this pretreated group, the combination of darlifarnib and cabozantinib delivered a 44% objective response rate (ORR) and a 94% disease control rate (DCR).
Notably, 75% of the patients experienced tumor shrinkage, with responders seeing reductions between 32% and 47%.
The data suggests that darlifarnib may act to "resensitize" tumors to VEGFR TKI therapy, overcoming established mechanisms of resistance.
Clinical investigators noted durable treatment durations reaching 56 weeks, with six of the sixteen patients remaining on the therapy at the time of the data cut-off.
The safety profile across multiple dose levels was described as manageable, even when paired with full-dose cabozantinib.
The FIT-001 trial has already advanced to a Phase 1b dose expansion phase to further refine the optimal dosing schedule.
These results build on Kura’s growing momentum in the precision oncology space, following the recent FDA approval of KOMZIFTI (ziftomenib) for acute myeloid leukemia.