Kura Oncology Announces Preliminary Data from Its Farnesyl Transferase Inhibitor (FTI) Programs at the 2025 European Society for Medical Oncology (ESMO) Congress

Rhea-AI Summary

Kura Oncology (Nasdaq: KURA) announced preliminary clinical and preclinical results for its farnesyl transferase inhibitor programs presented at ESMO 2025, highlighting darlifarnib (KO-2806) and tipifarnib combinations.

Key highlights: darlifarnib monotherapy showed tolerable dosing from 3–10 mg/day with on‑target activity in HRAS‑mutant tumors; darlifarnib+cabozantinib produced an ORR of 33–50% and DCR of 80–100% in clear cell RCC (50% ORR reported in an RCC cohort); tipifarnib+alpelisib produced an ORR of 47% at tipifarnib 1200 mg + alpelisib 250 mg in PIK3CA‑altered HNSCC. A virtual investor event and webcast were scheduled for October 18, 2025.

Positive

• Darlifarnib+cabozantinib ORR 33%–50% in clear cell RCC
• Darlifarnib+cabozantinib DCR 80%–100% in clear cell RCC
• Tipifarnib+alpelisib ORR 47% at 1200 mg/250 mg in PIK3CA‑altered HNSCC
• Darlifarnib monotherapy tolerable at 3–10 mg/day with on‑target activity in HRAS‑mutant tumors

Negative

• Alpelisib monotherapy ORR 0% (BOR: SD) in the tested HNSCC population
• Tipifarnib monotherapy not expected to provide clinical benefit in this population
• Key combination data are preliminary from dose‑escalation and remain subject to ongoing study

Insights

Clinical Development Strategist

Kura reports promising early combo efficacy for FTIs, notably high response rates in RCC and HNSCC cohorts, supporting further development.

Kura Oncology presented preliminary clinical and preclinical data for its farnesyl transferase inhibitors darlifarnib and tipifarnib showing activity as monotherapy in HRAS‑mutant tumors and as combination partners with TKIs, PI3Kα inhibitors and KRAS inhibitors. The company reports an objective response rate (ORR) of 50% and disease control rate (DCR) of 80% in a renal cell carcinoma cohort treated with darlifarnib plus cabozantinib in a dose‑escalation trial, plus an ORR of 47% for tipifarnib plus alpelisib in heavily pretreated PIK3CA‑altered HNSCC at the specified dose.

The business mechanism is clear in the disclosed data: FTIs are presented as agents that block farnesylation‑dependent pathways, including hyperactivated mTORC1 signaling in tumor endothelial and squamous tumor cells, which the company links to improved activity when combined with targeted agents. Safety is described as manageable across reported dose ranges, including at the full label dose of cabozantinib. Key dependencies and risks are explicit: the findings are preliminary and arise from early phase (dose‑escalation and Phase 1) cohorts, with ongoing dose‑escalation and a planned Phase 1b dose‑expansion noted; durability, broader reproducibility, and formal dose selection remain unresolved in the disclosed material.

Concrete near‑term items to watch are the completion and readout of the ongoing dose‑escalation, the planned Phase 1b dose‑expansion for darlifarnib plus cabozantinib, and additional cohort-level data for HRAS‑mutant monotherapy and darlifarnib+PI3Kα combinations; these are relevant over the next 6–18 months given the ongoing early‑phase work and the virtual investor event on October 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 to host a virtual investor event today, October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET / 7:30 p.m. CEST

SAN DIEGO, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced new preliminary data from its farnesyl transferase inhibitor (FTI) programs – darlifarnib (KO-2806) and tipifarnib – presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, from October 17 – 21, 2025.

“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 Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “The clinical data reported here at ESMO 2025 build on our preclinical presentation from last month and underscore darlifarnib’s transformative potential as a versatile combination partner to major classes of precision medicines.”

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 Glenn Hanna, M.D., Director, Center for Cancer Therapeutic Innovation, Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School – an investigator on both the FIT-001 and KURRENT-HN trials. “Darlifarnib demonstrates robust activity in HRAS-mutant solid tumors, which are typically very challenging to treat using existing therapies. In addition, the combination of tipifarnib and alpelisib demonstrated robust antitumor activity in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations — a population where monotherapy alpelisib provides only modest clinical benefit. These combination data are very exciting and set the stage for combining darlifarnib with PI3Kα inhibitors.”

1. 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 ESMO Congress 2025 online program.

Virtual Investor Event
Kura will host a webcast and conference call today, October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET / 7:30 p.m. CEST featuring management and Glenn A. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute and Associate Professor of Medicine, Harvard Medical School.

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 clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

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
Dr. Hanna's disclosures include institutional research support and an advisory role with Kura Oncology, Inc.

Kura Contact
Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com

FAQ

What preliminary results did KURA report at ESMO 2025 for darlifarnib (KURA)?

Kura reported darlifarnib monotherapy tolerable at 3–10 mg/day with on‑target activity in HRAS‑mutant tumors and combination activity with cabozantinib in RCC.

What response rates did KURA report for darlifarnib plus cabozantinib in RCC (KURA)?

The company reported an ORR of 33%–50% and a DCR of 80%–100% in clear cell RCC, with a 50% ORR noted in an RCC cohort.

What was the clinical activity of tipifarnib plus alpelisib in PIK3CA‑altered HNSCC (KURA)?

Tipifarnib 1200 mg plus alpelisib 250 mg produced an ORR of 47% in heavily pretreated, PIK3CA‑altered HNSCC patients.

Did KURA announce any safety or tolerability findings for the FTI combinations at ESMO 2025 (KURA)?

Kura reported a manageable safety profile for darlifarnib and tipifarnib combinations across multiple doses, including at full label dose of cabozantinib in RCC.

Will KURA provide more detail on these ESMO 2025 data and when (KURA)?

Presentations are available on the company website and a virtual investor webcast and replay were scheduled for October 18, 2025.

What are the near‑term development plans KURA disclosed for darlifarnib combinations (KURA)?

Kura is continuing dose‑escalation studies and plans a Phase 1b dose‑expansion to assess the optimal biologically active dose for the darlifarnib+cabozantinib combination.