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    DRUG:

    pivekimab sunirine (PVEK)

    i
    Other names: PVEK, IMGN632, IMGN 632, IMGN-632
    Company:
    AbbVie
    Drug class:
    DNA replication inhibitor, CD123-targeted antibody-drug conjugate
    Related drugs:
    2ms
    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)
    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)
    4ms
    Current status and future potential of CD123-based targeted therapies for acute leukemia. (PubMed, Expert Opin Biol Ther)
    It discusses completed and ongoing clinical trials for agents such as tagraxofusp, pivekimab sunirine, flotetuzumab, vibecotamab, and investigational CAR T-cell therapies (e.g. MB-102, UCART123v1.2). While clinical activity has been demonstrated, especially in BPDCN, therapeutic durability and safety remain hurdles. Precision in antigen targeting, combination strategies, and toxicity management will be critical for successful integration of CD123-directed therapies into standard clinical practice.
    Review • Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    flotetuzumab (MGD006) • Elzonris (tagraxofusp-erzs) • pivekimab sunirine (PVEK) • UCART123 • vibecotamab (XmAb14045) • MB-102
    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)
    over1year
    CADENZA: Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN (clinicaltrials.gov)
    P1/2, N=179, Active, not recruiting, AbbVie | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive • IL3RA expression
    |
    pivekimab sunirine (PVEK)
    over1year
    Overcoming Tagraxofusp-Erzs Monotherapy Resistance in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in a Real-World Clinical Setting. (PubMed, J Immunother Precis Oncol)
    Currently, standard treatment strategies include clinical trials; chemotherapy regimens such as hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HCVAD); and tagraxofusp-erzs (TAG, previously SL-401) which is the first-in-class targeted therapy against CD123...However, despite promising results, there are still patients who may be resistant to TAG monotherapy and/or who respond but eventually relapse. Herein, we discuss an important patient case of BPDCN treated with TAG and review BPDCN treatment strategies.
    Journal • Real-world evidence • Real-world
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Venclexta (venetoclax) • doxorubicin hydrochloride • cyclophosphamide • vincristine • Elzonris (tagraxofusp-erzs) • pivekimab sunirine (PVEK)
    over1year
    CADENZA: Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN (clinicaltrials.gov)
    P1/2, N=179, Active, not recruiting, ImmunoGen, Inc. | Trial primary completion date: Dec 2024 --> Sep 2023
    Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    pivekimab sunirine (PVEK)
    almost2years
    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, ImmunoGen, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2
    Enrollment closed • Phase classification
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive • IL3RA positive
    |
    Venclexta (venetoclax) • azacitidine • decitabine • pivekimab sunirine (PVEK)