The risk of death was reduced by 34% among participants receiving the combination of venetoclax and azacitidine (OS HR=0.66, p<0.001); the median overall survival was 14.7 months for venetoclax combination vs. 9.6 months for placebo
Among patients on venetoclax and azacitidine, 36.7% achieved complete remission compared to 17.9% in the placebo group (p<0.001)
The venetoclax and azacitidine arm displayed higher response rates in composite response and CR+CRh when compared to placebo at 66.4% vs. 28.3% (p<0.001) and 64.7% vs. 22.8% (p<0.001), respectively
58% of participants treated with venetoclax and azacitidine reached red blood cell and platelet transfusion independence vs. 34% in placebo (p<0.001)
In the venetoclax and azacitidine arm, hematologic adverse events are the most prevalent treatment emergent adverse events (TEAEs), while tumor lysis syndrome was resolved with the standard of care without dose discontinuation
DiNardo C, et al. A randomized, double-blind, placebo-controlled study of venetoclax with azacitidine vs azacitidine in treatment-naïve patients with acute myeloid leukemia ineligible for intensive therapy: VIALE-A. EHA25, Abstract LB2601.