*Risk factors for TLS include circulating blasts, high burden of leukaemia involvement in bone marrow, elevated pre-treatment LDH levels, and reduced renal function.1
†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
AML=acute myeloid leukaemia; AZA=azacitidine; CYP3A=cytochrome P450 3A; IV=intravenous; LDH=lactate dehydrogenase; SC=subcutaneous;
TLS=tumour lysis syndrome; WBC=white blood cell.