Kura Oncology Reports Preliminary Data on Darlifarnib and Cabozantinib Combination Therapy

Kura Oncology announced new preliminary data from a subset analysis of patients with clear cell renal cell carcinoma previously treated with cabozantinib in the ongoing FIT-001 clinical trial of darlifarnib in combination with cabozantinib. Results were presented at the 2026 International Kidney Cancer Symposium: Europe in Paris, France. The analysis specifically evaluated patients with ccRCC who had previously received cabozantinib, a population that typically derives limited benefit from subsequent therapy. In this setting, the combination of darlifarnib and cabozantinib demonstrated robust antitumor activity along with a manageable safety profile as demonstrated in all RCC patients across multiple dose levels, including full dose cabozantinib. These findings are consistent with clinical and preclinical data presented at the 2025 European Society for Medical Oncology and in earlier data disclosures supporting the potential of darlifarnib to enhance the activity of VEGFR-targeted therapies and to address mechanisms of resistance. Clinical Activity in Cabozantinib-Pretreated Patients: Objective response rate was 44%, with a disease control rate of 94% across all doses tested in this population. Tumor shrinkage observed in 75% of patients, with reductions ranging from 32% to 47% among responders. Antitumor activity observed in a heavily pre-treated, cabozantinib-exposed population, including patients whose best response to prior cabozantinib was stable disease. Responses observed in patients previously treated with cabozantinib in the immediate prior line as well as those who had received other TKIs in addition to cabozantinib. Treatment durations ranged from 8 to 56 weeks, with six patients remaining on therapy at the time of data cutoff. These findings are notable given that patients who progress on cabozantinib are generally considered unlikely to respond to subsequent cabozantinib therapy. "Patients with advanced ccRCC whose disease progresses on cabozantinib have limited treatment options," said Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology Director of Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. "The tumor shrinkage and high disease control rate observed with darlifarnib in combination with cabozantinib suggest this approach may offer meaningful clinical benefit in a refractory setting or in patients with disease progression after therapy."