*VIALE-A was a Phase 3, randomised, double-blind, placebo-controlled study comparing the efficacy and safety of VEN+AZA vs AZA alone in first-line AML patients ineligible for intensive chemotherapy. VEN+AZA reached its primary efficacy endpoints, achieving statistically significant increases in overall survival and composite complete remission rates (CR+CRi) vs AZA alone. In VIALE-A, 66.4% (190/286) patients on VEN+AZA achieved CR+CRi vs. 28.3% (41/145) patients on AZA alone (P<0.001). 43.4% of patients (124/286) on VEN+AZA achieved CR/CRi before cycle 2 compared with 7.6% (11/145) of patients on AZA alone (P<0.001).1,2
For information on study design click here.
AZA=azacitidine; CR=complete remission; CRi=CR with incomplete blood count recovery; CYP3A=Cytochrome P450 3A; VEN=VENCLYXTO.