ASH 2021 | Oral azacitidine maintenance in AML: QUAZAR AML-001 results after 52 months of follow-up

Andrew Wei, MBBS, PhD, Alfred Hospital and Monash University, Melbourne, Australia, presents the latest findings from the Phase III randomized, placebo-controlled QUAZAR AML-001 trial (NCT01757535) investigating the use of oral azacitidine maintenance therapy for patients with acute myeloid leukemia (AML) in first remission following intensive chemotherapy (IC). Over 470 patients in remission after IC who were not eligible for stem cell transplantation were enrolled in the study and randomized to receive oral azacitidine or placebo. Previously reported data after 41 months of follow-up showed that azacitidine maintenance was associated with a significantly prolonged overall survival (OS) compared to placebo. However, the tails of the OS curves began to converge beyond 48 weeks, and thus an updated analysis with an additional 1 year of follow-up was conducted. In this analysis, the median OS was unchanged. However, the OS curves showed greater separation with additional follow-up, indicating a sustained OS benefit with oral-azacitidine. Characteristics of patients alive at 3-years were compared to those who were not, and it was shown that as well as intermediate-risk cytogenetics and NPM1 mutations, MRD-negativity post-IC was associated with long term survival. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.