VIALE-A study design
A randomized (2:1), double-blind, placebo-controlled, multicenter, phase 3 study that evaluated the efficacy and safety of VENCLEXTA (venetoclax tablets) in combination with azacitidine (VEN+AZA; N=286) vs placebo with azacitidine (PBO+AZA; N=145) in adults with newly diagnosed AML who were ≥75 years of age, or had comorbidities (see baseline characteristics) that precluded the use of intensive induction chemotherapy. 1 View full study design.

Primary endpoint data
VEN+AZA demonstrated superior overall survival (OS) vs PBO+AZA. Median OS: VEN+AZA: 14.7 months; 95% CI: (11.9, 18.7) vs PBO+AZA: 9.6 months; 95% CI: (7.4, 12.7). OS: HR=0.66; 95% CI: (0.52, 0.85); P<0.001. 1 View KM curve.

Almost 3x the rate of remission,* longer mDOR, and greater transfusion independence observed with VEN+AZA vs PBO+AZA 1

Greater transfusion independence conversion and/or maintenance rates were observed with VEN+AZA vs PBO+AZA 1

DOCR (duration of CR) is defined as the number of days from the date of first response of CR to the date of earliest evidence of confirmed morphologic relapse, confirmed progressive disease, or death due to disease progression. 1

DOCR+CRh (duration of CR+CRh) is defined as the number of days from the date of first response of CR+CRh (the first of either CR or CRh) to the date of earliest evidence of confirmed morphologic relapse, confirmed progressive disease, or death due to disease progression. 1

Transfusion independence was defined as no RBC and no platelet transfusion during any consecutive ≥56-day post-baseline period. 1

*Remission refers to CR+CRh.

VEN=VENCLEXTA; AZA=azacitidine; PBO=placebo; mDOR=median duration of response; mDOCR=median duration of complete remission; mDOCR+CRh=median duration of complete remission and complete remission with partial hematologic recovery; RBC=red blood cell.

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