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 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.

Overall survival (OS) outcomes in different mutational subgroups 3,4

OS was statistically significant in the consolidated IDH1/2 group of patients in the VEN+AZA arm 4

  • OS in IDH1/2 was a prespecified secondary endpoint

Descriptive prespecified analysis of OS in secondary and exploratory endpoints 1,3,4

  • OS in the IDH1/2 and FLT3 subgroups was a prespecified secondary endpoint. Other select biomarker subgroups (IDH1, IDH2, TP53, and NPM1) and cytogenetic risk were prespecified exploratory endpoints
  • OS in FLT3 did not meet statistical significance (P=0.205) and does not support conclusions of efficacy or safety for this subgroup

Remission was achieved in different mutational subgroups, including IDH1/2 and FLT3 5

  • More than half of patients with an IDH1/2 or FLT3 mutation achieved remission in the VEN+AZA group 
  • CR+CRh rates for IDH1/2 and FLT3 were prespecified secondary endpoints 4

VEN=VENCLEXTA; AZA=azacitidine; PBO=placebo; IDH=isocitrate dehydrogenase; FLT=fms-like tyrosine kinase; TP53=tumor protein p53; NPM=nucleophosmin.

Previous — See remission and transfusion independence

See Study M14-358 summary of efficacy — Next