Dr. Atallah on the Clinical Implications of the QUAZAR AML-001 Trial in AML

Ehab L. Atallah, MD, professor of medicine, section head, Hematological Malignancies, Division of Hematology and Oncology, Medical College of Wisconsin, discusses the clinical implications of the phase 3 QUAZAR AML-001 trial (NCT01757535) in acute myeloid leukemia (AML).

The QUAZAR AML-001 trial evaluated oral azacitidine (Onureg) vs placebo as maintenance therapy in patients with AML who were in their first remission following intensive chemotherapy. Evaluable patients had intermediate- or high-risk disease, says Atallah. Patients received 300 mg of oral azacitidine or placebo daily for 14 days every 28 days until disease progression or intolerance, says Atallah. The results of the study revealed that patients had a significantly prolonged overall survival and relapse-free survival with oral azacitidine compared with placebo and tolerated the regimen well.

As a result of these findings, on September 1, 2020, the FDA approved oral azacitidine for use as maintenance therapy for patients with AML who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.

Notably, oral azacitidine is not interchangeable with intravenous azacitidine because the dosing and pharmacokinetics are different between the agents, concludes Atallah.