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    Association details:
    Biomarker:NPM1 mutation
    Cancer:Acute Myelogenous Leukemia
    Drug:ziftomenib (KO-539) (Menin-MLL inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    First in human clinical trial of the study drug KO-539 in patients with leukemia

    Excerpt:
    ...Adult patients that have documented specific genetic subtypes determined by local institutional genomic testing and defined as either lysine[K]-specific methyltransferase 2-rearranged (KMT2A-r) or nucleophosmin 1-mutant (NPM1-m). ...
    Trial ID:
    2019-001545-41
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

    Excerpt:
    ...- Has a documented NPM1 mutation or KMT2A rearrangement....
    Trial ID:
    NCT06001788
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML

    Excerpt:
    ...- Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML...
    Trial ID:
    KOMET-007
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

    Excerpt:
    ...Patients with a documented nucleophosmin 1 mutation (NPM1-m) 2....
    Trial ID:
    KOMET-001
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SOHO 2023
    Title:

    Activity, Tolerability, and Resistance Profile of the Menin Inhibitor Ziftomenib in Adults With Relapsed/Refractory NPM1‑Mutated AML

    Published date:
    09/01/2023
    Excerpt:
    Ziftomenib demonstrates significant clinical activity in heavily pretreated and co-mutated R/R NPM1m AML patients where 35% of patients achieved CR with a manageable safety profile.
    Trial ID:
    KOMET-001
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2023
    Title:

    UPDATED DATA FOR ZIFTOMENIB IN PATIENTS WITH NPM1-MUTATED RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA

    Published date:
    05/11/2023
    Excerpt:
    KOMET-001 is a global, open-label Ph 1/2 study of ziftomenib in adult patients (pts) with R/R AML. The dose escalation and randomized, multi-dose expansion in pts with KMT2Ar or NPM1m R/R AML is fully enrolled….the complete remission (CR) rate for NPM1m pts treated with 600mg was 30%, composite CR rate (CRc) was 35%, and ORR rate was 40%...
    Trial ID:
    KOMET-001
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2023
    Title:

    Title: ACTIVITY, TOLERABILITY, AND RESISTANCE PROFILE OF THE MENININHIBITOR ZIFTOMENIB IN ADULTS WITH RELAPSED/REFRACTORY NPM1-MUTATED AML

    Published date:
    05/11/2023
    Excerpt:
    Ziftomenib continues to demonstrate significant clinical activity in heavily pretreated and co-mutated R/R NPM1mAML pts where 35% of pts achieved CR.
    Trial ID:
    KOMET-001
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2022
    Title:

    64 Update on a Phase 1/2 First-in-Human Study of the Menin-KMT2A (MLL) Inhibitor Ziftomenib (KO-539) in Patients with Relapsed or Refractory Acute Myeloid Leukemia

    Published date:
    11/03/2022
    Excerpt:
    We present here preliminary KOMET-001 (NCT04067336) data, an ongoing Phase (P) 1/2 study of ziftomenib (KO-539), an inhibitor of KMT2A-menin interaction, in adult pts with relapsed/refractory (R/R) AML….At 200 mg, the 2 NPM1m pts responded…
    DOI:
    https://doi.org/10.1182/blood-2022-167412
    Trial ID:
    KOMET-001