On May 14, 2025 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported 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) (Free EHA Whitepaper) Congress, to be held in Milan, Italy, from June 12-15, 2025 (Press release, Kura Oncology, MAY 14, 2025, View Source [SID1234653064]).

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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 (Free EHA Whitepaper) 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 EHA (Free EHA Whitepaper)web.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.