Oral azacitidine maintenance after intensive chemotherapy versus venetoclax and azacitidine: real world outcomes in newly diagnosed acute myeloid leukemia

Oral azacitidine (Oral-AZA) is recommended as maintenance therapy for patients with newly diagnosed acute myeloid leukemia (ND AML) achieving remission with intensive chemotherapy (IC) but not transplant candidates; venetoclax plus injectable azacitidine (VEN-AZA) is recommended for patients ineligible for IC. Some patients may be considered candidates for either regimen. This retrospective study used Flatiron Health's database to compare treatment patterns and clinical outcomes with Oral-AZA maintenance after IC (IC🡪Oral-AZA) versus frontline VEN-AZA. Relapse-free survival (RFS) and overall survival (OS) were analyzed at 4 different time points, including from Oral-AZA initiation (IC🡪Oral-AZA cohort) or from remission (VEN-AZA cohort) in the Core Analysis. Median RFS was 14.9 and 8.1 months for IC🡪Oral-AZA and VEN-AZA propensity score-matched cohorts, in the Core Analysis (<i>n</i> = 32 in each; <i>p</i> = 0.027); median OS was 18.7 and 15.2 months (<i>p</i> = 0.034). In patients with AML, IC🡪Oral-AZA significantly improved RFS and OS compared with VEN-AZA.