SAN DIEGO, July 14, 2026
Kura Oncology announced that updated long-term follow-up data from the ongoing FIT-001 Phase 1a clinical trial evaluating darlifarnib in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC) will be presented in an oral session at the 2026 Kidney Cancer Research Summit (KCRS). The updated findings are expected to further demonstrate the potential of darlifarnib to enhance VEGFR-targeted therapy while supporting the company’s broader precision oncology strategy across multiple targeted treatment classes.
Long-Term Follow-Up Reinforces Combination Potential in Advanced ccRCC
The presentation will feature updated clinical outcomes from heavily pretreated, cabozantinib-naïve patients with advanced clear cell renal cell carcinoma enrolled in the Phase 1a portion of the FIT-001 study. The results build upon previously reported data presented at ESMO 2025 and IKCS Europe 2026, providing additional evidence that darlifarnib may improve the depth and durability of response when combined with VEGFR-targeted therapy. Kura believes the combination addresses the ongoing need for more effective treatment strategies in patients with advanced kidney cancer who have progressed after prior therapies.
Randomized Phase 1b Trial Continues to Advance Toward Registrational Development
Kura Oncology is actively enrolling patients across the United States and Europe into the randomized Phase 1b portion of FIT-001, comparing darlifarnib plus cabozantinib against cabozantinib alone in cabozantinib-naïve patients with refractory advanced ccRCC. The study is designed to identify the recommended Phase 3 dose and support a planned registrational Phase 3 program expected to begin in 2028. The company believes the ongoing trial represents an important milestone toward establishing darlifarnib as a novel combination agent for renal cell carcinoma.
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Broader Precision Oncology Strategy Expands Beyond Kidney Cancer
Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) designed to inhibit RHEB farnesylation and suppress adaptive mTORC1 signaling, a key mechanism associated with resistance to targeted therapies. Beyond renal cell carcinoma, Kura plans to expand development into additional targeted therapy combinations, including a future study evaluating darlifarnib with daraxonrasib in previously treated RAS-mutated pancreatic ductal adenocarcinoma. The company believes this precision combination strategy has the potential to enhance multiple targeted therapy classes while overcoming treatment resistance across several solid tumor types.
Source: Kura Oncology, press release
