Kura Oncology and Kyowa Kirin Launch Clinical Trial Evaluating Dual Inhibition of NPM1 and FLT3 Mutations in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
Kura Oncology (NASDAQ:KURA) and Kyowa Kirin (TSE:4151) have initiated patient dosing in a new cohort of the KOMET-007 clinical trial, evaluating the combination of ziftomenib with cytarabine, daunorubicin, and quizartinib in newly diagnosed acute myeloid leukemia (AML) patients.
The trial targets patients with FLT3/NPM1 co-mutations, which affect approximately 30% of newly diagnosed adult AML patients and up to 50% of adult patients with NPM1-mutated AML. Ziftomenib, which has received FDA Breakthrough Therapy Designation for treating adult patients with relapsed/refractory NPM1-mutated AML, will be evaluated for safety, tolerability, and activity in combination with intensive chemotherapy and quizartinib.
Kura Oncology (NASDAQ:KURA) e Kyowa Kirin (TSE:4151) hanno avviato la somministrazione ai pazienti in una nuova coorte dello studio clinico KOMET-007, valutando la combinazione di ziftomenib con cytarabina, daunorubicina e quizartinib in pazienti adulti con leucemia mieloide acuta (AML) recentemente diagnosticata.
Lo studio è rivolto a pazienti con co-mutazioni FLT3/NPM1, che interessano circa il 30% dei pazienti adulti con AML recentemente diagnosticata e fino al 50% dei pazienti adulti con AML mutata NPM1. Ziftomenib, che ha ricevuto FDA Breakthrough Therapy Designation per il trattamento di pazienti adulti con AML mutata NPM1 in recidiva/refrattaria, sarà valutato per sicurezza, tollerabilità ed attività in combinazione con chemioterapia intensiva e quizartinib.
Kura Oncology (NASDAQ:KURA) y Kyowa Kirin (TSE:4151) han iniciado la dosificación de pacientes en una nueva cohorte del ensayo KOMET-007, evaluando la combinación de ziftomenib con cytarabina, daunorubicina y quizartinib en pacientes adultos con leucemia mieloide aguda (LMA) recién diagnosticada.
El ensayo se dirige a pacientes con doble mutación FLT3/NPM1, que afectan aproximadamente al 30% de los pacientes adultos con LMA recién diagnosticada y hasta el 50% de los pacientes adultos con LMA mutada NPM1. Ziftomenib, que ha recibido la Designación de Terapia Innovadora (Breakthrough Therapy Designation) de la FDA para tratar a pacientes adultos con LMA mutada NPM1 en recaída/refractaria, será evaluado por seguridad, tolerabilidad y actividad en combinación con quimioterapia intensiva y quizartinib.
Kura Oncology (NASDAQ:KURA)와 Kyowa Kirin (TSE:4151)은 새로운 KOMET-007 임상시험 코호트에서 환자 투여를 시작했습니다. 이 연구는 신규 진단 성인 AML 환자들을 대상으로 ziftomenib와 cytarabine, daunorubicin, 그리고 quizartinib의 병용을 평가합니다.
이 임상은 FLT3/NPM1 공변이를 가진 환자들을 대상으로 하며, 이는 신규 진단된 성인 AML 환자의 약 30%, NPM1 돌연변이 AML 환자의 성인 중 최대 50%에 해당합니다. FDA의 Breakthrough Therapy Designation를 받은 ziftomenib은 집중 화학요법 및 quizartinib와의 병용에서 안전성, 내약성 및 활성을 평가받게 됩니다.
Kura Oncology (NASDAQ:KURA) et Kyowa Kirin (TSE:4151) ont commencé l’administration des patients dans une nouvelle cohorte de l’essai clinique KOMET-007, évaluant la combinaison de ziftomenib avec la cytarabine, la daunorubine et le quizartinib chez des patients adultes atteints de leucémie myéloïde aiguë (LMA) nouvellement diagnostiqués.
L’essai cible des patients présentant des co-mutations FLT3/NPM1, qui concernent environ 30% des patients adultes nouvellement diagnostiqués et jusqu’à 50% des patients adultes atteints de LMA mutée NPM1. Le ziftomenib, qui a reçu la Breakthrough Therapy Designation de la FDA pour le traitement des adultes atteints de LMA mutée NPM1 en rechute/réfractory, sera évalué pour la sécurité, la tolérance et l’activité en association avec une chimiothérapie intensive et le quizartinib.
Kura Oncology (NASDAQ:KURA) und Kyowa Kirin (TSE:4151) haben die Behandlung von Patienten in einer neuen Kohorte der klinischen Studie KOMET-007 begonnen, die die Kombination von Ziftomenib mit Cytarabin, Daunorubicin und Quizartinib bei neu diagnostizierter AML bewertet.
Die Studie richtet sich an Patienten mit FLT3/NPM1-Co-Mutationen, die etwa 30% der neu diagnostizierten erwachsenen AML-Patienten und bis zu 50% der erwachsenen Patienten mit NPM1-mutierter AML betreffen. Ziftomenib, das die FDA Breakthrough Therapy Designation zur Behandlung erwachsener Patienten mit rezidivierender/refraktärer NPM1-mutierter AML erhalten hat, wird auf Sicherheit, Verträglichkeit und Aktivität in Kombination mit intensiver Chemotherapie und Quizartinib bewertet.
أعلنت Kura Oncology (NASDAQ:KURA) و Kyowa Kirin (TSE:4151) عن بدء إعطاء المرضى في معطى جديد من تجربة KOMET-007 السريرية، حيث يتم تقييم الجمع بين ziftomenib مع السيترادين، والدنوروبيسين، وquizartinib لدى مرضى اللوكيميا النخاعية الحادة حديثة التشخيص.
تستهدف الدراسة المرضى المصابين بطفرتي FLT3/NPM1، والتي تؤثر على نحو 30% من مرضى AML البالغين حديثي التشخيص وحتى 50% من مرضى AML البالغين المصابين بطفرة NPM1. سيُقيَّم ziftomenib، الحاصل على FDA Breakthrough Therapy Designation لعلاج مرضى البالغين المصابين بـ AML المتغيرة NPM1 في الانتكاس/الشلل، من حيث السلامة والتحمل والنشاط عند جمعه مع العلاج الكيميائي المكثف وquizartinib.
Kura Oncology（NASDAQ:KURA） 与 Kyowa Kirin（TSE:4151） 已在 KOMET-007 临床试验的新队列中启动患者给药，评估将 ziftomenib 与阿糖胞苷、多柔比星和 quizartinib 联合用于新诊断的成人 AML 患者。
试验针对具有 FLT3/NPM1 共突变 的患者，该共突变影响大约 30% 的新诊断成人 AML 患者，以及高达 50% 的携带 NPM1 突变的成人 AML 患者。获得 FDA Breakthrough Therapy Designation 的 ziftomenib 将在与强化化疗及 quizartinib 联合治疗中，评估其安全性、耐受性和活性。
- FDA Breakthrough Therapy Designation received for ziftomenib in NPM1-mutated AML
- Preclinical data shows synergistic effects between ziftomenib and FLT3 inhibitors without increased toxicity
- Clinical trials now active in multiple frontline settings covering up to 50% of incident AML patients in the U.S.
- Ziftomenib's safety and efficacy have not yet been established by any regulatory authority
- FLT3/NPM1 co-mutated AML patients currently face high relapse rates
Insights
Kura's ziftomenib expands into frontline AML with FLT3/NPM1 mutations, addressing a critical treatment gap.
The clinical trial announcement represents a significant expansion of ziftomenib's development program into newly diagnosed AML patients with FLT3/NPM1 co-mutations. This is strategically important as these mutations occur in approximately 30% of newly diagnosed adult AML cases, with FLT3 appearing in up to 50% of NPM1-mutated AML.
The scientific rationale is compelling - preclinical evidence shows ziftomenib synergizes with FLT3 inhibitors like quizartinib without increasing toxicity. This approach targets two critical oncogenic drivers simultaneously, potentially addressing the high relapse rates in this population.
The KOMET-007 trial design combining ziftomenib with standard chemotherapy (7+3) plus quizartinib represents a comprehensive approach to frontline treatment. The endpoints focusing on complete remission rates are clinically meaningful for AML.
Ziftomenib's Breakthrough Therapy Designation for relapsed/refractory NPM1-mutated AML provides regulatory validation of its potential. This expansion into frontline settings now covers approximately 50% of incident AML cases in the U.S., significantly broadening the drug's market potential.
This development positions Kura strategically in the competitive landscape of targeted AML therapies, particularly for genetically defined subgroups with poor prognosis. The collaboration with Kyowa Kirin also provides international development capabilities that could accelerate the pathway to potential approval.
– Expanding clinical experience and safety profile of ziftomenib support its evaluation in combination with approved FLT3 inhibitors in frontline AML –
– FLT3 mutations occur in approximately
– Ziftomenib clinical trials are now active in multiple frontline settings that include up to
SAN DIEGO and TOKYO, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced dosing of the first patient in a cohort of the KOMET-007 clinical trial (NCT05735184). This cohort evaluates ziftomenib, a once-daily, investigational oral menin inhibitor, combined with cytarabine and daunorubicin (7+3) as well as quizartinib, for patients with newly diagnosed acute myeloid leukemia (AML). Despite recent advances, including regulatory approvals of FLT3 inhibitors such as quizartinib, patients with FLT3/NPM1 co-mutations face a high risk of relapse and limited durable treatment options. Ziftomenib is the only menin inhibitor to have received Breakthrough Therapy Designation by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory NPM1-mutated AML.
“Patients with FLT3/NPM1 co-mutated AML, a significant subset of newly diagnosed cases, face high relapse rates and limited durable treatment options,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Preclinical data demonstrate that ziftomenib synergizes with FLT3 inhibitors such as quizartinib, potentially enhancing activity without increasing toxicity. The KOMET-007 trial, alongside our recently launched KOMET-017 registrational trial combining ziftomenib with intensive and non-intensive chemotherapy, reflects our commitment to integrating menin inhibition across AML treatment regimens to improve patient outcomes.”
“Initiation of the FLT3 inhibitor cohort in the KOMET-007 trial marks a pivotal advancement in addressing the urgent needs of patients with FLT3/NPM1 co-mutated AML,” said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. “FLT3 mutations play a critical role in AML, driving aggressive leukemia cell proliferation, leading to poor prognosis, higher relapse rates, and shorter overall survival. Kyowa Kirin is proud to collaborate with Kura Oncology to advance this innovative menin inhibitor combination, aiming to improve outcomes for AML patients throughout the continuum of care.”
The trial arm will evaluate safety, tolerability and activity of intensive chemotherapy and quizartinib in combination with ziftomenib in adult patients with newly diagnosed FLT3-ITD / NPM1 co-mutated AML. Primary and secondary endpoints include complete remission (CR) and composite complete remission (CRc). More information regarding this trial arm and the KOMET-007 trial is available at www.clinicaltrials.gov (identifier: NCT05735184).
Ziftomenib is currently under clinical development, and its safety and efficacy have not been established by any regulatory authority.
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 both menin inhibition and 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.
About Kyowa Kirin
Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin’s values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com.
Kura 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 safety, tolerability, and therapeutic potential of ziftomenib, and expectations regarding trial enrollment. 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, the risk that the collaboration with Kyowa Kirin is unsuccessful, 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.
Kura Contact
Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com
Kyowa Kirin Contacts
Investors:
Ryohei Kawai
ir@kyowakirin.com
Media, Global:
Nobuyuki Manita
media@kyowakirin.com
FAQ
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