Phase Ib/II trial of quizartinib, decitabine and venetoclax in FLT3-ITD-mutated AML

Musa Yilmaz, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses a Phase Ib/II trial (NCT03661307) of quizartinib, a second generation FLT3 inhibitor, plus decitabine with or without venetoclax in acute myeloid leukemia (AML) patients with FLT3-ITD mutations. Preclinical evidence shows strong synergy when venetoclax is added to quizartinib, which does not achieve durable responses as a monotherapy. Results from the initial dose escalation phase show substantial improvement in composite complete remission rates for the decitabine + quizartinib + venetoclax cohort when compared to decitabine + quizartinib alone. Patients in the triplet arm achieved a 6-month overall survival of 86%. Given the high activity and manageable safety profile of the triplet seen in both relapsed/refractory and newly diagnosed patients, accrual to the triplet combination arm is ongoing. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.