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    Association details:
    Biomarker:CD123 positive
    Cancer:Acute Myelogenous Leukemia
    Drug:Venclexta (venetoclax) (Bcl2 inhibitor) +
    pivekimab sunirine (IMGN632) (DNA replication inhibitor, CD123-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

    Excerpt:
    ...- Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC])....
    Trial ID:
    IMGN632-0802
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2021
    Title:

    Safety and Efficacy from a Phase 1b/2 Study of IMGN632 in Combination with Azacitidine and Venetoclax for Patients with CD123-Positive Acute Myeloid Leukemia

    Published date:
    11/04/2021
    Excerpt:
    This Phase 1b/2 study was designed to determine the safety, tolerability, and preliminary anti-leukemic activity of IMGN632 combined with AZA and VEN in patients with CD123-positive AML....Efficacy was seen across all cohorts/doses and schedules (efficacy evaluable population, n=29). The objective response rate (ORR) was 55% with a composite complete remission (CCR) rate of 31% (1 CR, 4 CRh, 2 CRp, 2 CRi).
    Secondary therapy:
    azacitidine
    DOI:
    10.1182/blood-2021-146503