SAN DIEGO, Calif. and PARIS, France — Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, today announced new preliminary data from a subset analysis of patients with clear cell renal cell carcinoma (ccRCC) previously treated with cabozantinib in the ongoing FIT-001 clinical trial (NCT06026410) of darlifarnib (KO-2806) in combination with cabozantinib. Results were presented at the 2026 International Kidney Cancer Symposium (IKCS): 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 (ESMO) 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 (N=16):
- Objective response rate (ORR) was 44%, with a disease control rate (DCR) 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.”
The FIT-001 study is evaluating darlifarnib in patients with RCC at once-daily doses of 3 mg, 5 mg or 8 mg alternating 7 days on and off in combination with cabozantinib at once-daily doses of 60 mg or 40 mg. All patients must have received prior immunotherapy. The study has advanced into Phase 1b dose expansion to assess an optimal biologically active dose for the combination.
“These data highlight the potential of darlifarnib to overcome resistance to prior cabozantinib and enhance the activity of VEGF TKIs in patients with advanced RCC,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “We are highly encouraged by these results and are committed to advancing this combination to evaluate further its potential to deliver meaningful benefit for RCC patients.”
2026 IKCS: Europe Presentation
The presentation from 2026 IKCS: Europe is available on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section.
Virtual Investor Event
Kura will host a webcast and conference call today, April 17, 2026, at 7:30 a.m. PT / 10:30 a.m. ET / 4:30 p.m. CEST featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Director of Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.
About Kura Oncology
Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.
Conflict of Interest Disclosure
Dr. Ayanambakkam’s disclosures include consulting or advisory roles with Regeneron, Pfizer Oncology, Astellas Pharma, Bristol Myer Squibb – WINN CDA, Pharmacosmos Therapeutics, Natera Oncology, Foundation Medicine,National Cancer Institute, Native American Center of Cancer Health Excellence, AVEO, Johnson & Johnson, Kura Oncology.
Kura Contact
Investors and Media:
Greg Mann
858-987-4046
[email protected]