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    DRUG CLASS:

    CD123-targeted antibody-drug conjugate

    Related drugs:
    25d
    Study of AZD9829 in CD123+ Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=56, Completed, AstraZeneca | Active, not recruiting --> Completed
    Trial completion
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    1m
    NCI-2023-03572: Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms (clinicaltrials.gov)
    P1, N=30, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Dec 2027 --> Dec 2029
    Trial completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Chr t(15;17)
    |
    cytarabine • idarubicin hydrochloride • fludarabine IV • pivekimab sunirine (PVEK) • Starasid (cytarabine ocfosfate)
    2ms
    Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm. (PubMed, J Clin Oncol)
    PVEK, with convenient dosing, led to high, durable responses, especially in frontline BPDCN, and a manageable safety profile.
    Clinical • Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    pivekimab sunirine (PVEK)
    2ms
    Study of AZD9829 in CD123+ Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=56, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=104 --> 56 | Trial completion date: Jan 2027 --> Mar 2026 | Trial primary completion date: Jan 2027 --> Oct 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    2ms
    BYON4413.001: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Byondis B.V. | Recruiting --> Active, not recruiting | N=100 --> 16 | Trial completion date: Mar 2027 --> Feb 2026 | Trial primary completion date: Dec 2026 --> Sep 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • First-in-human
    |
    BYON4413
    3ms
    A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, AbbVie
    New P1 trial • Adverse events
    |
    pivekimab sunirine (PVEK)
    8ms
    Study of AZD9829 in CD123+ Hematological Malignancies (ChiCTR2500104541)
    P1/2, N=132, Recruiting, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.; Institute of Hematolog
    New P1/2 trial
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    1year
    Study of AZD9829 in CD123+ Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=104, Recruiting, AstraZeneca | N=65 --> 104 | Trial completion date: Apr 2027 --> Jan 2027 | Trial primary completion date: Apr 2027 --> Jan 2027
    Enrollment change • Trial completion date • Trial primary completion date
    1year
    IMGN632-0802: IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=218, Active, not recruiting, AbbVie | Trial completion date: Apr 2026 --> Feb 2027 | Trial primary completion date: Apr 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Venclexta (venetoclax) • azacitidine • decitabine • pivekimab sunirine (PVEK)
    1year
    The CD123 antibody-drug conjugate pivekimab sunirine exerts profound activity in preclinical models of pediatric acute lymphoblastic leukemia. (PubMed, Hemasphere)
    Importantly, a PDX with very high CD123 cell surface expression but resistant to in vivo PVEK treatment, failed to internalize the G4723A antibody while remaining sensitive to the PVEK payload, DGN549, suggesting a novel mechanism of resistance. In conclusion, PVEK was highly effective against a large panel of B-ALL PDXs supporting its clinical translation for B-lineage pediatric ALL.
    Preclinical • Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    IL3RA expression
    |
    pivekimab sunirine (PVEK)
    over1year
    IMGN632-0802: IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=218, Active, not recruiting, AbbVie | Trial completion date: Dec 2024 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive • IL3RA positive
    |
    Venclexta (venetoclax) • azacitidine • decitabine • pivekimab sunirine (PVEK)