Kura Oncology Announces Preliminary Data from Its Farnesyl Transferase Inhibitor (FTI) Programs at the 2025 European Society for Medical Oncology (ESMO) Congress
Kura Oncology Announces Preliminary Data from Its Farnesyl Transferase Inhibitor (FTI) Programs at the 2025 European Society for Medical Oncology (ESMO) Congress
10-18-2025
FTI mechanism addresses innate and adaptive resistance pathways common to targeted oncology therapies
Early clinical and preclinical data support darlifarnib’s potential to enhance clinical benefit of PI3Kα-, KRAS- and tyrosine kinase inhibitors
50% objective response rate and 80% disease control rate in renal cell carcinoma (RCC) cohort of darlifarnib plus cabozantinib in ongoing dose-escalation clinical trial
“Kura Oncology is pioneering the use of FTIs in combination with tyrosine kinase inhibitors (TKIs), PI3Kα inhibitors and KRAS inhibitors to address mechanisms of innate and adaptive resistance, thereby enhancing and extending the clinical benefit of these single-agent targeted therapies,” said
Darlifarnib as Monotherapy in Advanced Solid Tumors – FIT-001 Phase 1 Trial
- HRAS-mutant (HRAS-m) tumors are sensitive to FTIs
- Manageable safety and tolerability profile at doses from 3 to 10 mg per day
- Encouraging antitumor activity in advanced HRAS-m solid tumors across multiple dose levels, demonstrating on-target activity and a broad therapeutic window
- Data support further evaluation of KO-2806 in combinations across tumor types
Darlifarnib + Cabozantinib in Renal Cell Carcinoma – FIT-001 Phase 1 Trial
- FTI mechanism blocks hyperactivated mTORC1 signaling in tumor endothelial cells
- Manageable safety profile in RCC patients across multiple doses, including at the full label dose of cabozantinib
- Antitumor activity observed across all doses in RCC, including in prior cabozantinib-exposed patients
- ORR: 33%–50% in ccRCC (17-50% in patients with prior cabozantinib exposure)
- DCR: 80%–100% in ccRCC
- Dose-escalation study ongoing and Phase 1b dose-expansion planned to assess optimal biologically active dose for combination
Tipifarnib + Alpelisib in PIK3CA-altered Head and Neck Squamous Cell Carcinoma – KURRENT-HN Phase 1 Trial
- FTI mechanism blocks hyperactivated mTORC1 signaling in squamous tumor cells
- Manageable safety profile in HNSCC patients across multiple doses
- Robust antitumor activity was observed in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations
- ORR: 47% was observed at a daily dose of tipifarnib 1200 mg + alpelisib 250 mg
- Alpelisib monotherapy provides modest clinical benefit (ORR: 0%; BOR: SD)1 and tipifarnib monotherapy not expected to provide clinical benefit in this population
- Data generation options for darlifarnib + PI3Kα inhibitor combinations in solid tumors are being assessed
“These results highlight the potential of FTIs to meaningfully enhance the clinical activity of PI3Kα inhibitors in molecularly selected patients,” said
- Juric et al. J Clin Oncol 2018;36(13):1291-9.
Presentations
The presentations are available on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section, and in the
Virtual Investor Event
Kura will host a webcast and conference call today,
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
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of FTIs to address resistance mechanisms in cancer, the potential benefits of combining FTIs with targeted therapies, and the potential of FTIs to impact patients with cancer. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Conflict of Interest Disclosure
Kura Contact
Investors and Media:
858-987-4046
gmann@kuraoncology.com
Source: Kura Oncology, Inc.