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 library.ehaweb.org.