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ASH 2021: Updated Overall Survival From QUAZAR AML-001 Trial of Oral Azacitidine in AML in First Remission

By: Vanessa A. Carter, BS
Posted: Wednesday, December 15, 2021

Andrew H. Wei, MBBS, PhD, of The Alfred Hospital, Melbourne, Australia, and colleagues conducted the QUAZAR AML-001 trial—a phase III study assessing oral azacitidine in patients with acute myeloid leukemia (AML) in first remission after intensive chemotherapy. Their findings, presented during the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 871), revealed a sustained, long-term overall survival benefit with azacitidine versus placebo.

This trial enrolled 472 patients with newly diagnosed AML who had intermediate- or poor-risk cytogenetics and achieved complete remission with or without incomplete hematologic recovery after intensive chemotherapy. Within 4 months of complete remission, participants were randomly assigned 1:1 to receive oral azacitidine (n = 238) or placebo (n = 234).

Of the total population, 91% of individuals had de novo AML, and 86% had intermediate-risk cytogenetics. Oral azacitidine was continued in 39 patients, with 31.4% and 15.5% of individuals receiving more than 24 months of azacitidine or placebo, respectively. At the updated follow-up, 54 participants on azacitidine were still alive, with 31 still receiving treatment; 35 individuals on placebo remained alive.

At the primary data cutoff, azacitidine was associated with a significantly longer overall survival versus placebo (24.7 vs. 14.8 months; P < .001) and was sustained at the median follow-up of 51.7 months (P = .0008). With additional follow-up, however, the Kaplan-Meier overall survival curves appeared to separate, with estimated 3-year survival rates of 37.4% with azacitidine and 27.9% with placebo.

Long-term survivors (≥ 3 years) consisted of 83 patients given azacitidine and 57 given placebo. At diagnosis, this group was more likely to have intermediate-risk cytogenetics (95% vs. 82%), an NPM1 mutation (45% vs. 9%), and measurable residual disease (MRD) positivity (33% vs. 52%) at baseline compared with those who died or were censored. Of note, 71% of long-term survivors achieved MRD negativity on treatment, compared with 15% of patients in the less than 3 years cohort. 

Disclosure: For full disclosures of the study authors, visit ash.confex.com.



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