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Ziftomenib

Phase 3

Acute Myeloid Leukemia (AML) | Small molecule | Oncology |Kura Oncology, Inc.|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,300
FDA Designations
BREAKTHROUGH_THERAPYFAST_TRACKORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07007312Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AMLPHASE3 RECRUITING 1,300 — — Sep 26, 2025Nov 1, 2031Jun 3, 202671 United States, Czechia +8
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Study Endpoints
Primary Endpoints
Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)
Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion

OS

Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR)
Assessed up to 36 months after last patient inclusion

CR rate per European Leukemia Network (ELN) 2022 criteria per Investigator assessment

Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS)
Defined as the time from randomization to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months after last patient inclusion

EFS

Intensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients
Assessed up to 36 months after last patient inclusion

CR rate per ELN 2022 criteria per Investigator assessment with central BM MRD negativity

Secondary Endpoints
Nonintensive Therapy Study: (EU & EU reference countries only): Complete remission (CR)
Up to 36 months after last patient inclusion
Nonintensive Therapy Study: Bone marrow (BM) measurable residual disease (MRD) negativity
Up to 36 months after last patient inclusion
Nonintensive Therapy Study: Complete remission (CR) + complete remission with partial hematologic recovery (CRh)
Up to 36 months after last patient inclusion
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nonintensive Therapy Study, Arm AEXPERIMENTALZiftomenib in combination with venetoclax+azacitidine
Nonintensive Therapy Study, Arm BPLACEBO_COMPARATORPlacebo in combination with venetoclax+azacitidine
Intensive Therapy Study, Arm AEXPERIMENTALZiftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance)
Intensive Therapy Study, Arm BEXPERIMENTALZiftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance)
Intensive Therapy Study, Arm CPLACEBO_COMPARATORPlacebo+cytarabine+daunorubicin (induction), placebo+cytarabine (consolidation), placebo (maintenance)
Interventions
NameTypeDescription
ZiftomenibDRUGOral administration
PlaceboDRUGOral administration
VenetoclaxDRUGOral administration
Azacitidine (AZA)DRUGIntravenous or subcutaneous administration
DaunorubicinDRUGIntravenous administration
Cytarabine (Ara-C)DRUGIntravenous administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites71

Key Inclusion Criteria: The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted: * Age ≥18 years at time of signing the informed consent form. * Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition...

Countries:United StatesCzechiaFranceGermanyItalyPhilippinesPortugalSouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07007312lastUpdatePostDate: changed
LOWJun 4, 2026NCT07007312lastUpdatePostDate: changed
LOWJun 4, 2026NCT07007312lastUpdatePostDate: changed
LOWJun 4, 2026NCT07007312lastUpdatePostDate: changed
LOWJun 4, 2026NCT07007312lastUpdatePostDate: changed
LOWMay 26, 2026NCT07007312primaryCompletionDate: changed
LOWMay 24, 2026NCT07007312studyFirstPostDate: changed