A Phase II study led by The University of Texas MD Anderson Cancer Center (TX, USA) has demonstrated that combining standard chemotherapy azacitidine (AZA) with enasidenib (ENA) improves remission rates in patients newly diagnosed with a specific form of acute myeloid leukemia (AML). The results of the study were presented at the American Society of Hematology Annual Meeting & Exposition (7–10 December, FL, USA).
“This study looked at AML involving mutations in a gene known as isocitrate dehydrogenase or IDH2,” commented Courtney DiNardo from The University of Texas. “IDH2 mutations occur in 8% to 19% of patients with AML. This is the first report of interim outcomes from this study, which represent at least 1 year of follow up for all participating patients. In general, the combination therapy was well tolerated.”
AZA is a hypomethylating chemotherapy, commonly used in older patients newly diagnosed with AML. ENA, an oral, small-molecule inhibitor, was approved in August 2017 by the US FDA for use in adult patients with relapsed or refractory mIDH2 AML.
In this randomized, open-label study, 101 mIDH2 newly diagnosed patients received either ENA plus AZA, or AZA alone in repeated 28-day cycles. Median ages were 74 years for the combination group and 75 years for AZA only.
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