Efficacy and safety of VENCLEXTA (venetoclax tablets) + azacitidine (VEN+AZA) were evaluated in a pivotal phase 3 trial 1,3

VIALE-A was a randomized (2:1), double-blind, placebo-controlled, multicenter, phase 3 clinical trial that evaluated the efficacy and safety of VEN+AZA vs placebo (PBO)+AZA in newly diagnosed patients with AML who were ≥75 years of age, or had comorbidities that precluded the use of intensive induction chemotherapy. 1,3

Comorbidities based on at least one of the following criteria 1:

  • Baseline ECOG performance status of 2-3
  • Severe cardiac or pulmonary comorbidity
  • Moderate hepatic impairment
  • CLcr <45 mL/min
  • Other comorbidities

Select clinical endpoints 1,3,4:

  • Primary endpoint: overall survival (OS)
  • Select secondary endpoints: CR, CR+CRh, CR+CRh by initiation of Cycle 2

Efficacy was based on OS, measured from the date of randomization to death from any cause 1

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

Complete remission with partial hematologic recovery (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). 1

IV=intravenous; ECOG=Eastern Cooperative Oncology Group; CLcr=creatinine clearance; TLS=tumor lysis syndrome; RBC=red blood cell.

Previous — Home

See baseline characteristics — Next