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

Prior treatment

• Participant has received prior therapy for AML.
• Participant is willing and able to receive standard induction therapy.
• Participant has received treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, SCT, chimeric antigen receptor-T therapy, or other experimental therapies.

Other

• Participant has AML with central nervous system involvement.
  • Note: Other inclusion/exclusion criteria may apply.

• Previously untreated with histological confirmation of AML by World Health Organization 2022 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.
• Participants 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:
  • 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%.
  • 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 condition for which the physician judges the participant to be unsuitable for intensive chemotherapy.
• ECOG performance status:
  • 0 to 2 for participants ≥75 years of age, or
  • 0 to 3 for participants ≥18 to 74 years of age.