Efficacy and safety of VENCLEXTA in acute myeloid leukemia (AML) were evaluated in combination with azacitidine (AZA), decitabine (DEC), or low-dose cytarabine (LDAC) 1

STUDY M14-358: OPEN-LABEL, NON-RANDOMIZED STUDY OF VENCLEXTA IN COMBINATION WITH AZA OR DEC 1

STUDY M14-387: OPEN-LABEL, NON-RANDOMIZED STUDY OF VENCLEXTA IN COMBINATION WITH LDAC 1

Efficacy was established based on the rate of CR and the duration of CR.

AML=acute myeloid leukemia; CLcr=creatinine clearance; ECOG=Eastern Cooperative Oncology Group; IV=intravenous; QD=once a day.

*All patients received TLS prophylaxis and were hospitalized for monitoring during the ramp-up.

CR was defined as absolute neutrophil count (ANC) >1,000/microliter, platelets >100,000/microliter, red blood cell transfusion independence, and bone marrow with <5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRh was defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter).