On November 3, 2025 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported 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) (Free ASH Whitepaper) 2025 Annual Meeting, on December 8, 2025 in Orlando, FL.
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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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper) submission timelines. The oral presentations at ASH (Free ASH Whitepaper) will include more mature data, including additional response-evaluable patients, longer follow-up and expanded safety summaries.
"At ASH (Free ASH Whitepaper) 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.
(Press release, Kura Oncology, NOV 3, 2025, View Source [SID1234659264])