Dr. Daver on the Utility of Maintenance Therapy in AML

Naval G. Daver, MD, an associate professor in the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses the utility of maintenance chemotherapy in acute myeloid leukemia (AML).

Inconsistent findings from phase 2 clinical trials have led to the long-standing debate of whether maintenance chemotherapy is effective in patients with AML, says Daver.

However, in May 2020 the FDA granted a priority review designation to oral azacitidine (CC-486) as maintenance therapy in patients with AML who achieved a complete remission (CR) or CR with incomplete blood count recovery following induction therapy with or without consolidation treatment, and who are not candidates for or choose to forego hematopoietic stem cell transplantation. The indication was based on findings from the phase 3 QUAZAR AML-001 study, in which the agent extended median overall survival compared with placebo as maintenance therapy in these patients.

Patients may forego transplant due to age, lack of donor availability, financial restrictions, or patient preference, says Daver. Notably, more than 30% of patients do not undergo transplant.

The positive findings from the QUAZAR AML-001 study establish a role for maintenance therapy in AML, says Daver.

Other research efforts should focus on whether maintenance therapy has utility in the post-transplant setting and for patients who are transplant-eligible, concludes Daver.