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    Association details:
    Biomarker:FLT3-TKD mutation
    Cancer:Acute Myelogenous Leukemia
    Drug:Venclexta (venetoclax) (Bcl2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Blood
    Title:

    Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with FLT3 Mutations

    Published date:
    11/05/2020
    Excerpt:
    CR+CRh rates in pts with FLT3-TKD were 69% (95% CI: 39%-91%)/20% (3%-56%) with mDoR 18.3 (95% CI: 3.0-NR)/NR (15.1-NR) mos. The median time to first CR/CRh response was 1.0/2.7 mos and 46%/0% achieved a response by initiation of C2. The mOS was 19.2 (95% CI:1.8-NR/10.0 (0.2-14.7) mos, respectively.
    Secondary therapy:
    azacitidine
    DOI:
    10.1182/blood-2020-134100
    Trial ID:
    Viale-a
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

    Excerpt:
    ...- AML with FLT3-ITD or FLT3-TKD mutations...
    Trial ID:
    NCT05554393
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    Gilteritinib or venetoclax in relapsed or refractory FLT3mut acute myeloid leukemia.

    Published date:
    05/25/2023
    Excerpt:
    This study compares two salvage therapies: gilteritinib or venetoclax and a hypomethylating agent (HMA; decitabine or azacitidine)....We retrospectively analyzed 129 patients with AML and mutated FLT3-ITD or FLT3-TKD….We compared patients treated with gilteritinib or venetoclax + HMA….The median overall survival in the gilteritinib cohort was 3.9 months — significantly shorter than 7.8 months for the venetoclax cohort (p = 0.048)....Venetoclax + HMA appears superior to gilteritinib for subsequent therapy after IC failure in FLT3mut AML, despite the gilteritinib cohort being significantly younger.
    Secondary therapy:
    decitabine; azacitidine
    DOI:
    10.1200/JCO.2023.41.16_suppl.e19046
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2022
    Title:

    Influence of Molecular Abnormalities on Treatment Response of Venetoclax Plus Azacytidine and Homoharringtonine Versus Venetoclax Plus Hypomethylating Agent in Relapsed/Refractory Acute Myeloid Leukemia

    Published date:
    11/03/2022
    Excerpt:
    Patients with TET2 (P=0.041), NPM1 (P=0.039), ASXL1 (P=0.044), FLT3-ITD/TKD (P=0.008), DNMT3A (P<0.001) or RAS (P=0.006) mutation or co-mutation of DNMT3A and FLT3 (P=0.020, DNMT3A and NPM1 (P=0.020) or DNMT3A and IDH/2 (P=0.016) acquired statistically higher rate of CR/CRi with VAH therapy as compared with VEN+HMA trerapy....AML1-ETO-positive AML patients poorly responded to VEN+HMA therapy (0/7), but responded much better to VAH treatment (5/7, P=0.005).
    Secondary therapy:
    azacitidine + BS-HH-002.SA
    DOI:
    10.1182/blood-2022-168004
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2020
    Title:

    1904 Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with FLT3 Mutations

    Published date:
    11/04/2020
    Excerpt:
    Complete response (CR)+CR with partial hematologic recovery (CRh) rates in FLT3mut pts (Ven+Aza/Pbo+Aza) were 65% (95% CI:48%-79%)/18% (5%-40%)...Among pts with FLT3-ITD, CR+CRh rates (Ven+Aza/Pbo+Aza) were 61% (95% CI: 41%-79%)/23% (5%-54%)...CR+CRh rates in pts with FLT3-TKD were 69% (95% CI: 39%-91%)/20% (3%-56%) with mDoR 18.3 (95% CI: 3.0-NR)/NR (15.1-NR) mos.
    Secondary therapy:
    azacitidine
    Trial ID:
    Viale-a; VIALE-A