A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Inclusion Criteria

• Previously untreated with histological confirmation of AML by World Health Organization criteria and are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity.

• Participant has any level of CD123 expression on blasts determined centrally by flow cytometry.

• Must be considered ineligible for intensive chemotherapy, defined by the following:

  • ≥75 years of age; or

  • ≥18 to 74 years of age with at least 1 of the following comorbidities:

    • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
    • Diffusing capacity of the lung for carbon monoxide of ≤65% or forced expiratory volume in 1 second ≤65%.
    • Left ventricular ejection fraction ≤50%.
    • Baseline creatinine clearance ≥30 to <45 milliliters/minute calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
    • Hepatic disorder with total bilirubin >1.5 x upper limit of normal.
    • Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor and Medical Monitor prior to enrollment.

• ECOG performance status:

  • Of 0 to 2 for participants if ≥75 years of age, or
  • Of 0 to 3 for participants ≥18 to 74 years of age.

Key

Exclusion Criteria

• Participant has received prior therapy for AML.

• Willing and able to receive standard induction therapy.

• Treatment for an antecedent hematologic disease with any of the following:

  • A hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy.
  • Chimeric antigen receptor-T therapy or other experimental therapies.

• AML with central nervous system involvement.

Note: Other inclusion/exclusion criteria may apply.