Japan-based pharmaceutical company Daiichi Sankyo has enrolled the first patient in its global Phase 3 QuANTUM-First trial to assess quizartinib in patients with newly diagnosed FLT3-ITD-positive (+) acute myeloid leukemia (AML).
AML is the most common type of acute leukemia, representing around 33% of all new cases of leukemia.
QuANTUM-First is a randomised, double-blind, placebo-controlled study investigating quizartinib and induction and consolidation chemotherapy combination and as maintenance monotherapy in patients with newly diagnosed FLT3-ITD+ AML.
The study's primary endpoint is event-free survival, while the secondary endpoints include overall survival, complete remission rate, composite complete remission rate and the percentage of subjects achieving a complete remission with no evidence of minimal residual disease.
Around 30% of patients with AML have a genetic mutation called FLT3-ITD, which is associated with more aggressive disease, leading in increased relapse rate and reduced overall survival than those without this mutation.
FLT3-ITD mutations are more common than FLT3-TKD mutations, which occur in around 10% of AML patients.
There is also controversy as to whether FLT3-TKD mutations carry as poor a prognosis as FLT3-ITD mutations.
There are currently no approved targeted treatments for FLT3-ITD+ AML, with little change in treatment of AML for the past three decades.
QuANTUM-First trial is expected to see enrollment of over 500 patients between 18 and 75 years of age in the Americas, Europe and Asia-Pacific.
Daiichi Sankyo executive vice president and global head for oncology research and development Antoine Yver said: "Given the high unmet need in FLT3-ITD+ AML, we are moving forward with a comprehensive clinical development program investigating the role of quizartinib in multiple lines of treatment including induction and consolidation chemotherapy, maintenance therapy and salvage therapy.
"Additionally, we also are looking to combine quizartinib with other investigational agents in our pipeline such as our MDM2 and BRD4 inhibitors where science suggests combining different mechanisms of action may help improve outcomes."