Site Editor

Rebecca Olin, MD, MS


EHA2021: Correlating MRD and Outcomes With Venetoclax and Azacitidine in AML

By: Lauren Harrison, MS
Posted: Monday, June 28, 2021

Patients with acute myeloid leukemia (AML) who had achieved complete remission and a measurable residual disease (MRD) response < 10-3 with venetoclax and azacitidine had better outcomes than patients with an MRD ≥ 10-3. Keith W. Pratz, MD, of the University of Pennsylvania, Philadelphia, presented these findings from the VIALE-A trial at the European Hematology Association Virtual Congress (EHA2021; Abstract S137).

The trial enrolled 286 patients with AML who were unfit for intensive chemotherapy. Patients received 400 mg of oral venetoclax on days 1 to 28 plus 75 mg/m2 of azacitidine on days 1 to 7 of a 28-day cycle. Bone marrow aspirate samples were taken at baseline, at the end of cycle 1, and the end of cycle 3 for flow cytometry analysis. MRD response was defined as less than 1 residual blast per 1,000 leukocytes (< 10-3).

All patients received a median of 12.5 cycles of venetoclax plus azacitidine. After a median follow up of 22 months, 37% of patients achieved an MRD response < 10-3, and 63% had an MRD response ≥ 10-3. Composite complete remission (complete remission plus complete remission with incomplete hematologic recovery) plus an MRD response < 10-3 was achieved by 86% of patients, whereas 73% achieved composite complete response plus an MRD response ≥ 10-3.

The median duration of response, overall survival, and event-free survival were not yet reached in the group who achieved an MRD response < 10-3. The 12-month estimate of response duration was 81% in those with an MRD response < 10-3, compared with 46.6% in those with an MRD response ≥10-3 group. The 12-month overall survival was likewise longer for those with an MRD response < 10-3 group, 94.0% compared with 67.9% for patients with an MRD response ≥ 10-3 cohort. Event-free survival at 12 months was estimated to be 83.2% and 45.4% among those with an MRD response < 10-3 and ≥ 10-3, respectively.

Grade 3 or higher adverse events in both response groups included febrile neutropenia, neutropenia, and thrombocytopenia, which was similar to the overall population.

Disclosure: For full disclosures of study authors, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.