Kura Oncology Announces Preliminary Data from Its Farnesyl Transferase Inhibitor (FTI) Programs at the 2025 European Society for Medical Oncology (ESMO) Congress
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.
Kura Oncology (Nasdaq: KURA) ha annunciato risultati clinici e preclinici preliminari per i suoi programmi in inibitori della farnesil transferase presentati all'ESMO 2025, evidenziando le combinazioni di darlifarnib (KO-2806) e tipifarnib.
Punti chiave: la monoterapia con darlifarnib ha mostrato una dose tollerabile da 3–10 mg/giorno con attività mirata nei tumori HRAS-mutanti; darlifarnib+cabozantinib ha prodotto un ORR del 33–50% e un DCR dell'80–100% nel RCC a cellule chiare (è stato riportato un ORR del 50% in una coorte RCC); tipifarnib+alpelisib ha prodotto un ORR del 47% a tipifarnib 1200 mg + alpelisib 250 mg in HNSCC alterato da PIK3CA. Un evento virtuale per investitori e una webcast erano pianificati per 18 ottobre 2025.
Kura Oncology (Nasdaq: KURA) anunció resultados clínicos y preclínicos preliminares de sus programas de inhibidores de la transferasa de farnesilo presentados en ESMO 2025, destacando las combinaciones de darlifarnib (KO-2806) y tipifarnib.
Puntos clave: la monoterapia con darlifarnib mostró una dosificación tolerable de 3–10 mg/día con actividad dirigida en tumores HRAS-mutantes; darlifarnib+cabozantinib obtuvo una ORR de 33–50% y un DCR de 80–100% en RCC de células claras (se reportó un ORR del 50% en una cohorte RCC); tipifarnib+alpelisib produjo una ORR de 47% con tipifarnib 1200 mg + alpelisib 250 mg en HNSCC alterado por PIK3CA. Un evento virtual para inversores y una webcast estaban programados para 18 de octubre de 2025.
Kura Oncology (Nasdaq: KURA)는 ESMO 2025에서 발표된 파네실 트랜스퍼레이스 억제제 프로그램의 예비 임상 및 전임상 결과를 발표했고, 다르리파니브(KO-2806)와 팁파니브의 조합을 강조했습니다.
주요 하이라이트: 다르리파니브 단독요법은 HRAS 돌연변이 종양에서 표적 활성화를 보이며 3–10 mg/일의 허용 가능한 용량을 보여주었습니다; 다르리파니브+cabozantinib는 RCC의 투명세포에서 ORR 33–50%, DCR 80–100%를 보였고 RCC 코호트에서 50% ORR이 보고되었습니다; tipifarnib+alpelisib은 PIK3CA 변이가 있는 HNSCC에서 tipifarnib 1200 mg + alpelisib 250 mg로 ORR 47%를 보였습니다. 투자자 가상 행사가 2025년 10월 18일로 예정되어 있었습니다.
Kura Oncology (NASDAQ: KURA) a annoncé des résultats cliniques et précliniques préliminaires pour ses programmes d'inhibiteurs de la farnésyltransférase présentés à l'ESMO 2025, mettant en évidence les combinaisons de darlifarnib (KO-2806) et tipifarnib.
Points clés : la monothérapie par darlifarnib a montré une dose tolérable de 3–10 mg/jour avec une activité ciblée dans les tumeurs HRAS-mutantes; darlifarnib+cabozantinib a produit une ORR de 33–50% et une DCR de 80–100% dans le RCC à cellules claires (50% ORR rapporté dans une cohorte RCC); tipifarnib+alpelisib a produit une ORR de 47% à tipifarnib 1200 mg + alpelisib 250 mg dans le HNSCC altéré par PIK3CA. Un événement virtuel pour investisseurs et une webcast étaient prévus le 18 octobre 2025.
Kura Oncology (Nasdaq: KURA) gab vorläufige klinische und präklinische Ergebnisse für ihre Farnesyltransferase-Hemmer-Programme bekannt, die auf der ESMO 2025 vorgestellt wurden, und hob Darlifarnib (KO-2806) sowie Tipifarnib-Kombinationen hervor.
Wichtige Highlights: Darlifarnib-Einzeltherapie zeigte eine tolerierbare Dosis von 3–10 mg/Tag mit on-target-Aktivität in HRAS-mutierten Tumoren; Darlifarnib+Cabozantinib ergab eine ORR von 33–50% und eine DCR von 80–100% im klarzelligen RCC (in einer RCC-Kohorte wurde eine ORR von 50% berichtet); Tipifarnib+Alpelisib zeigte eine ORR von 47% bei Tipifarnib 1200 mg + Alpelisib 250 mg in PIK3CA-alteriertem HNSCC. Eine virtuelle Investorenveranstaltung und Webcast waren für den 18. Oktober 2025 geplant.
شركة كورا أونكولوجي (ناسداك: KURA) أعلنت نتائج سريرية وتجريبية أولية لبرامج مثبطات فَرنسِيل ترانسفيراسي التي عُرضت في ESMO 2025، مع تسليط الضوء على تركيبات darlifarnib (KO-2806) وtipifarnib.
أهم النقاط: لوحظت جرعة تحمل من 3–10 ملغ/يوم في العلاج الأحادي بـ darlifarnib مع نشاط مستهدف في أورام HRAS‑mutant؛ أدى darlifarnib+cabozantinib إلى ORR من 33–50% وDCR من 80–100% في RCC الخلوي الواضح (ذكِر ORR بنسبة 50% في مجموعة RCC)؛ أظهر darlifarnib+alpelisib ORR قدره 47% عند جرعة darlifarnib 1200 mg + alpelisib 250 mg في HNSCC المصاب بـ PIK3CA. وحدث افتراضي للمستثمرين وبث ويب كان مقرراً في 18 أكتوبر 2025.
Kura Oncology（纳斯达克：KURA）宣布了在ESMO 2025上公布的其法rename转移酶抑制剂项目的初步临床和前临床结果，重点介绍 darlifarnib（KO-2806）和 tipifarnib 的联合用药。
要点： darlifarnib 单药治疗显示出 3–10 mg/日 的耐受剂量，且在 HRAS 突变肿瘤中显示出靶向活性；darlifarnib+cabozantinib 在清晰细胞 RCC 中的客观反应率（ORR）为 33–50%，疾病控制率（DCR）为 80–100%（RCC 队列中报告 ORR 为 50%）；tipifarnib+alpelisib 在 PIK3CA 改变的 HNSCC 中 tipifarnib 1200 mg + alpelisib 250 mg 的 ORR 为 47%。投资者虚拟活动及网络广播定于 2025-10-18 举行。
- 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
- 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
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
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
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
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
- ORR:
- 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
- ORR:
- 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.”
- 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
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