Kura Oncology and Kyowa Kirin to Present First Ziftomenib-FLT3 Inhibitor Clinical Data at ASH 2026

On November 4, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd (TSE: 4151) reported that eight abstracts related to ziftomenib, including four oral presentations and four posters, have been accepted for presentation at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 12-15 in New Orleans. Kura and Kyowa Kirin are working together under a strategic collaboration and license agreement to develop and commercialize ziftomenib for the treatment of acute myeloid leukemia (AML) worldwide.

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The presentations will include the first clinical results for ziftomenib in combination with the FLT3 inhibitors quizartinib and gilteritinib, longer-term frontline data for ziftomenib plus venetoclax and azacitidine, and an exploratory analysis of ziftomenib activity in molecularly defined AML subtypes beyond NPM1-mutated and KMT2A-rearranged disease.

"Our strategy is to establish ziftomenib as a preferred menin inhibitor for combination treatment, supported by clinical evidence across complementary therapeutic approaches," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Our first clinical results with quizartinib and gilteritinib extend this strategy into FLT3 inhibitor combinations. Together with longer-term venetoclax and azacitidine results and studies of additional combinations, these presentations will help define ziftomenib’s potential as a backbone therapy from initial diagnosis through relapsed or refractory disease."

FLT3 mutations occur in nearly one third of patients with AML and approximately one half of those with an NPM1 mutation. This overlap makes NPM1/FLT3 co-mutated AML an important population for ziftomenib combination development.

Two oral presentations will report preliminary safety and clinical activity findings from ziftomenib combinations with FLT3 inhibitors:

KOMET-007: Ziftomenib plus quizartinib and intensive chemotherapy (7+3) in newly diagnosed NPM1/FLT3-ITD co-mutated AML
KOMET-008: Ziftomenib plus gilteritinib in relapsed or refractory (R/R) NPM1/FLT3 co-mutated AML
A poster presentation from KOMET-007 will provide longer-term follow-up on response durability, overall survival, and safety with ziftomenib plus venetoclax and azacitidine in patients with newly diagnosed NPM1-mutated AML who are ineligible for intensive chemotherapy. These findings support the ongoing global, randomized Phase 3 KOMET-017 registrational study evaluating this combination.

An exploratory analysis from KOMET-001 will describe clinical activity with ziftomenib monotherapy in patients with R/R AML without NPM1 mutations or KMT2A rearrangements whose disease harbors other genomic alterations associated with MEIS1 expression. The findings support further investigation of ziftomenib in additional molecularly defined AML populations.

Two additional oral presentations will feature ziftomenib. The first will report initial results from the PedAL Phase 1 ITCC-101/APAL2020K trial sponsored by Blood Cancer United and Princess Maxima Center evaluating ziftomenib with fludarabine and cytarabine in pediatric R/R acute leukemia. The second will present preclinical findings from additional subsets of menin-associated leukemias.

All eight abstracts related to ziftomenib, including those from investigator-sponsored trials, are available on the ASH (Free ASH Whitepaper) website.

Select 2026 ASH (Free ASH Whitepaper) Presentation Details

Abstract Title Abstract Number Presentation Details
Ziftomenib combined with gilteritinib for relapsed/refractoryNPM1andFLT3co-mutated acute myeloid leukemia (AML): First results from the KOMET-008 phase 1 study
Oral Presentation #66 Session 617
December 12
10:45 a.m. CST
Great Hall AD
Ziftomenib combined with intensive induction (7+3) and quizartinib for newly diagnosedNPM1-m andFLT3-ITD+ acute myeloid leukemia (AML): Preliminary results from KOMET-007
Oral Presentation #902 Session 617
December 14
3:00 p.m. CST
Great Hall BC
Ziftomenib combined with venetoclax/azacitidine in newly diagnosedNPM1-m acute myeloid leukemia (AML): Long-term results from KOMET-007 Poster Presentation #5192 Session 617
December 14
6:00-8:00 p.m. CST
Hall F
Clinical activity of ziftomenib extends beyondNPM1-mutated andKMT2A-rearranged acute myeloid leukemia (AML) intoMEIS1-associated genomic subtypes Poster Presentation #5190 Session 617
December 14
6:00-8:00 p.m. CST
Hall F
Ziftomenib combined with fludarabine and cytarabine in pediatric relapsed/refractory acute leukemia withKMT2Arearrangements,NUP98rearrangements, orNPM1mutations: First results of the phase 1 ITCC-101/APAL2020K trial (NCT06376162)
Oral Presentation #666
Session 616
December 13
5:45 p.m. CST
Hall B
SETBP1-mutant leukemias depend on MENIN-associated KMT2A chromatin complexes to maintain leukemogenic transcriptional programs Oral Presentation #101 Session 636
December 12
10:30 a.m. CST
Hall C

Conference Call and Webcast

Kura will host a webcast and conference call at 8:30 a.m. ET / 5:30 a.m. PT on December 15, 2026, featuring Kura management, Eunice Wang, M.D., Chief of Leukemia Service and Professor of Oncology at Roswell Park Comprehensive Cancer Center, and Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies and Professor of Medicine at Yale School of Medicine. A live webcast and archived replay of the event will be available in the Investors section of Kura’s website at www.kuraoncology.com.

(Press release, Kura Oncology, NOV 4, 2026, View Source [SID1234674207])