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
– Data to be featured in two oral presentations on
– Broad development program assesses ziftomenib across diverse AML segments and treatment paradigms to inform appropriate use –
SAN DIEGO and TOKYO,
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
“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
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
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
About
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
Kura Contact
Investors and Media:
858-987-4046
gmann@kuraoncology.com
Kyowa Kirin Contacts
Investors:
Ryohei Kawai ir@kyowakirin.com
Media, Global:
Nobuyuki Manita media@kyowakirin.com
Source: Kura Oncology, Inc.
