– Response rates up to 50% across evaluated dose levels and median PFS of 13 months observed in pre-treated, cabozantinib-naïve, locally advanced or metastatic ccRCC patients –
– Activity compares favorably with historical outcomes for TKI and HIF-2α monotherapies -–
– Combination was well tolerated and safety profile consistent with reported profiles of the individual agents –
– Findings support potential for darlifarnib to enhance activity of VEGFR-targeted therapies in second- and third-line RCC settings –
– Global, randomized Phase 1b study underway to establish recommended Phase 3 dose –
– Investor call scheduled for today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET –
Las Vegas, Nevada (UroToday.com) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, announced updated Phase 1a results from the ongoing FIT-001 clinical trial (NCT06026410) demonstrating encouraging and durable clinical activity of darlifarnib plus cabozantinib in cabozantinib-naïve patients with advanced clear cell renal cell carcinoma (ccRCC). The results were presented at the 2026 Kidney Cancer Research Summit (KCRS) in Boston and support continued development of the combination, including dose selection for the randomized Phase 1b portion of the study.
The long-term data compare favorably with benchmarks for advanced RCC, showing robust antitumor activity with darlifarnib plus cabozantinib, as well as evidence of durable benefit. The combination had a manageable safety profile across all dose levels, including when administered with full-dose cabozantinib.
Clinical Activity in Cabozantinib-naïve ccRCC Patients (N=34):
- Objective response rate ranged from 33% to 50% across evaluated darlifarnib dose levels
- Median progression free survival was 13 months across pooled dose levels
- Median duration of response was not estimable at most dose levels assessed because multiple responses remain ongoing
- Durable clinical benefit was observed across all evaluated combination dose levels, with more than half of patients remaining on treatment at data cut-off
- The safety and tolerability profile was manageable and generally consistent with reported safety profiles of the individual agents
- Supportive care, including for neutropenia, was not allowed during the dose-limiting toxicity study period
- Neutropenia was successfully managed with dose interruption/reduction and supportive care (as allowed after the initial dose-limiting toxicity period)
“The response rates and progression-free survival observed with darlifarnib plus cabozantinib are encouraging in this refractory, pretreated, cabozantinib-naïve population, particularly given the limited treatment options after prior immunotherapy, immune check point inhibitors, and VEGFR-targeted therapy,” said Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology, Assistant Medical Director Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. “Continued follow-up will further define the durability of benefit.”Duration of Treatment and Clinical Outcomes
Clinical benefit observed across combination dose levels, with multiple patients remaining on treatment.
“These updated Phase 1a data continue to support the potential for darlifarnib to enhance VEGFR-targeted therapy in advanced RCC and have informed the dose combinations advancing into the randomized Phase 1b portion of FIT-001,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Cabozantinib-naïve patients represent an increasingly important treatment population as cabozantinib is often reserved for later lines of therapy following immunotherapy-based regimens. We look forward to longer follow-up from Phase 1a and randomized data from Phase 1b as we continue development toward a planned registrational study.”
Kura is currently enrolling patients in the U.S. and E.U. in the randomized Phase 1b dose-optimization portion of FIT-001 in cabozantinib-naïve, refractory ccRCC. The Phase 1b portion is evaluating darlifarnib plus cabozantinib versus cabozantinib alone and is designed to inform selection of a recommended Phase 3 dose for a planned registrational study in 2028.
Source: Kura Oncology, Inc. (2026). Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal Cell Carcinoma Patients at KCRS 2026 [Press release]. https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-reports-durable-clinical-activity-darlifarnib-plus.