Courtney DiNardo, MD, MSCE, on Enasidenib Plus Azacitidine in Newly Diagnosed AML

Courtney DiNardo, MD, MSCE, elaborated on interim phase II results regarding enasibenib plus azacitidine in patients with newly diagnosed acute myeloid leukemia, and the results from the QUAZAR trial.

At the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, held December 7-10, in Orlando, Florida, Courtney DiNardo, MD, MSCE, from the department of leukemia in the division of cancer medicine at The University of Texas MD Anderson Cancer Center, explained the interim phase II results regarding newly diagnosed acute myeloid leukemia (AML) and touched upon the QUAZAR study presented there.


The interim analysis identified that there were significantly improved responses in the combination arm. Compared to a complete remission rate of about 12% it was 53%, which is a pretty dramatic difference. The overall response rate was similarly improved from 40% up to 70% and the event free survival in these newly diagnosed patients went from 11 months to 17 months.

The QUAZAR study is going to be presented tomorrow, and the published data on the website is really quite impressive. This study was for patients who received intensive chemotherapy as their front-line therapy for AML, people who were 55 years of age and older, who received induction and up to 2 consolidation cycles. If they didn’t transition onto a transplant, they were randomized 1:1 to either oral azacytidine (Vidaza) maintenance for 14 days per cycle, or a placebo. The relapsed free survival and overall survival in patients receiving the oral azacitidine was essentially double, showing that there’s certainly a role for maintenance therapy with oral hypomethylating agents, and so this may, if the data tomorrow is as compelling as were seeing, I think this is going to be potentially one of the next approvals in our area, and the ability to have an oral hypomethylating agent is really going to be transformative. That’ll be great to be able to provide our older patients with a much more manageable treatment.