Kura Oncology and Kyowa Kirin Announce Combination Data for Ziftomenib in Oral Presentation at the 2025 European Hematology Association (EHA) Congress
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Insights
Positive data presentation on ziftomenib in AML trials suggests promising efficacy; multiple trial updates indicate momentum in clinical development program.
The upcoming presentation of ziftomenib combination data at the European Hematology Association Congress represents a significant milestone in Kura's clinical development program. The oral presentation format is particularly noteworthy, as it indicates the scientific committee found the data compelling enough to warrant highlighted status among submissions.
The KOMET-007 trial specifically evaluates ziftomenib in combination with standard chemotherapy regimens (7+3 and venetoclax/azacitidine) for patients with NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML). These genetic subtypes represent well-defined molecular segments of AML that have shown particular sensitivity to menin inhibition in preclinical models.
The Chief Medical Officer's statement that the findings "underscore the potential" and strengthen their "confidence" suggests the data is positive, though specific efficacy and safety metrics aren't disclosed in this release. The planned progression to a pivotal Phase 3 trial (KOMET-017) further supports this interpretation, as companies typically advance to Phase 3 only when Phase 1 data demonstrates both safety and preliminary efficacy.
Beyond KOMET-007, the company is presenting data from multiple trials in their program, including KOMET-001 (in relapsed/refractory setting) and details on the registrational KOMET-017 study design. This comprehensive approach across treatment lines and settings indicates a robust clinical development strategy targeting specific molecular AML subtypes where menin inhibition may provide significant benefit.
– Ziftomenib combined with 7+3 in 1L NPM1-m or KMT2A-r AML patients selected for oral presentation on Thursday, June 12th –
– Updated dataset to be presented in oral presentation at EHA2025 Congress –
SAN DIEGO and TOKYO, May 14, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that an abstract highlighting clinical data from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, has been accepted for presentation at the upcoming 2025 European Hematology Association (EHA) Congress, to be held in Milan, Italy, from June 12-15, 2025.
KOMET-007 is a multicenter Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine plus daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data presented at EHA will be from the Phase 1a dose-escalation and Phase 1b dose-expansion portions of the trial, in the cohort evaluating ziftomenib in combination with 7+3 in newly diagnosed patients with AML.
“The latest findings from the KOMET-007 trial underscore the potential of the combination of ziftomenib with intensive chemotherapy for newly diagnosed patients, strengthening our confidence in its role as a potential treatment option for a broad segment of the AML community,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “The Phase 1a/b KOMET-007 trial positions us to further evaluate this combination, and its potential to expand treatment options for AML patients, in the upcoming pivotal Phase 3 KOMET-017 trial.”
In addition to the oral presentation, two abstracts for the KOMET-001 and KOMET-017 trials have been accepted for an encore presentation and publication, respectively. Session titles and information for all three abstracts are listed below and are now available on the EHAweb.org website. Updated data from the published abstract for KOMET-007 will be disclosed during the oral presentation.
Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia (AML): Updated Phase 1a/b Results from KOMET-007
Session: s411. Menin inhibitors and venetoclax-based regimens in AML treatment
Date and Session Time: Thursday, June 12, 2025; 5:00PM - 6:15PM CEST
Location: Allianz MiCo, Milano Convention Centre, Auditorium
Publication Number: S136
Ziftomenib in Relapsed/Refractory NPM1-Mutant Acute Myeloid Leukemia: Phase 1b/2 Clinical Activity and Safety Results from the Pivotal KOMET-001 Study Session: Poster Session 1
Date and Time: Friday, June 13, 2025; 6:30 PM - 7:30 PM CEST
Location: Allianz MiCo, Milano Convention Centre, Poster Hall
Publication Number: PF473
Registrational Phase 3 Study of Ziftomenib in Combination with Non-Intensive or Intensive Chemotherapy for Newly Diagnosed NPM1-m and/or KMT2A-r Acute Myeloid Leukemia (AML): The KOMET-017 Trial
Online Publication Only
Publication Number: PB2573
Copies of the presentations will be available on Kura's website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.
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 consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory (R/R) NPM1-m AML. In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in KOMET-001, a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML, has been completed, and in the second quarter of 2025, the companies announced submission of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-m AML. Kura and Kyowa Kirin are conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-m and KMT2A-r AML. KO-2806, a next-generation farnesyl transferase inhibitor (FTI), is being evaluated in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. For additional information, please visit Kura’s 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 statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib; potential benefits of combining ziftomenib with intensive chemotherapy and the expected timing and presentation of results and data from clinical trials. 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, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, 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 the Company faces, please refer to the Company'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 Contacts
Investors:
Patti Bank
Managing Director
(415) 513-1284
patti.bank@icrhealthcare.com
Media:
media@kuraoncology.com
Kyowa Kirin Contacts
Investors:
Ryohei Kawai
ir@kyowakirin.com
Media, Global:
Wataru Suzuki,
media@kyowakirin.com
FAQ
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