Dr. Daver on Anticipated Breakthroughs in AML

Naval G. Daver, MD, associate professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, discusses anticipated breakthroughs in acute myeloid leukemia (AML).

In May 2020, the FDA granted a priority review designation to a new drug application for the use of oral azacitidine (CC-486) as a maintenance treatment for adult patients with AML who achieved 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. A decision for the application is slated for September 3, 2020. The drug is expected to be approved according to the favorable data from the phase 3 QUAZAR AML-001 trial, says Daver. If approved, the drug will be the first agent to receive an indication as maintenance therapy in AML.

Moreover, the MDM2 inhibitor idasanutlin (RG-7388) is being evaluated in the phase 3 MIRROS trial. If positive, the drug will become the first agent to demonstrate broad benefit in a phase 3 trial of a relapsed/refractory population, says Daver.

In addition to immunotherapy, which is expected to gain more traction in the field, the field will see more combinations with venetoclax (Venclexta) and chemotherapy, MDM2 inhibitors, and FLT3 inhibitors, concludes Daver.