Kura Oncology and Kyowa Kirin Announce Presentations of Ziftomenib Ven/Aza Combination Data in Frontline and Relapsed/Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia at 2025 ASH Annual Meeting
Rhea-AI Summary
Kura Oncology (NASDAQ: KURA) and Kyowa Kirin will present updated clinical data for ziftomenib combined with venetoclax and azacitidine (ven/aza) from the KOMET-007 Phase 1a/b trial at the ASH 2025 Annual Meeting on December 8, 2025 in Orlando, FL.
The programs include: an updated analysis in relapsed/refractory NPM1-m or KMT2A-r AML and initial Phase 1b results in newly diagnosed NPM1-m AML. The abstracts used a June 2025 cutoff; ASH presentations will show more mature safety and response data with longer follow-up and additional evaluable patients. Presentation times are 10:45–11:00 AM ET (Oral #764) and 11:15–11:30 AM ET (Oral #766). Slides will be posted on Kura's publications page after the meeting.
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– Data to be featured in two oral presentations on December 8, 2025 –
– Broad development program assesses ziftomenib across diverse AML segments and treatment paradigms to inform appropriate use –
SAN DIEGO and TOKYO, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that results from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, will be featured in two oral presentations at the upcoming American Society of Hematology (ASH) 2025 Annual Meeting, on December 8, 2025 in Orlando, FL.
KOMET-007 is an ongoing Phase 1a/b dose-escalation/expansion study of ziftomenib in combination with standard-of-care chemotherapies in adults with NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The combination data presented at ASH will include data in both newly diagnosed adults with NPM1-m AML and updated data in adults with relapsed or refractory NPM1-m or KMT2A-r AML treated with ziftomenib in combination with the non-intensive chemotherapy regimen of venetoclax and azacitidine (ven/aza).
The two ziftomenib abstracts are based on an earlier data cutoff of June 2025, in line with ASH submission timelines. The oral presentations at ASH will include more mature data, including additional response-evaluable patients, longer follow-up and expanded safety summaries.
“At ASH 2025, we look forward to sharing data evaluating ziftomenib with venetoclax / azacitidine in both the newly diagnosed and relapsed/refractory AML settings,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “These trials are part of a comprehensive and focused clinical development plan designed to understand how menin inhibition can benefit the greatest number of patients in need. We expect to continue generating data from the combination of ziftomenib with commonly used treatment backbones across multiple trials, including the KOMET-017 Phase 3 trial. The emerging profile from this effort gives us confidence that ziftomenib as monotherapy and in combination represents a meaningful step forward for patients if these findings are confirmed.”
ASH Presentations:
Ziftomenib in Combination with Venetoclax and Azacitidine in Relapsed / Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia: Updated Phase 1a/b safety and clinical activity results from KOMET-007
Session 616. Menin inhibitors and FLT3 inhibitors in AML
Monday, December 8, 2025; 10:45-11:00 AM ET
Chapin Theater (320)
Oral #764
Ziftomenib in Combination with Venetoclax and Azacitidine in Newly Diagnosed NPM1-m Acute Myeloid Leukemia: Phase 1b Results from KOMET-007
Session 616. Menin inhibitors and FLT3 inhibitors in AML
Monday, December 8, 2025; 11:15-11:30 AM ET
Chapin Theater (320)
Oral #766
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 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.
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 expected timing and presentation of results and data from the KOMET-007 clinical trial; the expectation of continued data generation from the combination of ziftomenib with commonly used treatment backbones across multiple trials, including the KOMET-017 trials; and the therapeutic potential of ziftomenib as a monotherapy and in combination with commonly used treatment backbones;. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early clinical trials do not demonstrate safety and/or efficacy in later clinical trials; 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 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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