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    Association details:
    Biomarker:IL3RA positive
    Cancer:Acute Myelogenous Leukemia
    Drug:pivekimab sunirine (IMGN632) (DNA replication inhibitor, CD123-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat

    Excerpt:
    ...- Patient must have leukemic blasts that are CD123-positive by flow cytometry as determined either by the treating institution or through reference laboratory testing....
    Trial ID:
    NCT05320380
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    A study of IMGN632 alone or in combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

    Excerpt:
    ...Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]). ...
    Trial ID:
    2019-002477-56
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Blood
    Title:

    Broad Activity for the Pivekimab Sunirine (PVEK, IMGN632), Azacitidine, and Venetoclax Triplet in High-Risk Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML)

    Published date:
    11/15/2022
    Excerpt:
    In this phase 1b/2 study, eligible patients with CD123-positive R/R AML received PVEK+AZA+VEN in a three-drug escalation over a 28-day cycle…Response data were available for 61 patients with R/R AML. The objective response rate (ORR [CR, CRh, CRp, CRi, MLFS) was 51% with a composite complete remission (CCR [CR, CRh, CRp, CRi]) rate of 31%. VEN-naïve patients had an ORR and CCR of 62% and 47% compared with 37% and 11%, respectively, in patients who had prior VEN exposure.
    Secondary therapy:
    venetoclax + azacitidine
    DOI:
    https://doi.org/10.1182/blood-2022-158030