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Enrollment is underway in a Phase 3 clinical trial, QuANTUM-First, assessing Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) orally available quizartinib for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who have a genetic mutation called FLT3-ITD, which occurs in ~30% of AML cases. The mutation is associated with more aggressive cancer, characterized by a higher relapse rate and reduced overall survival (OS).
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QuANTUM-First is a double-blind, placebo-controlled study that will randomize ~536 patients to receive either quizartinib plus induction and consolidation chemotherapy or placebo plus induction and consolidation chemo. The primary endpoint is event-free survival (EFS) at Year 2. Secondary endpoints include OS at Year 2, complete remission rate (CR) at the end of the first induction cycle (Day 42), composite CR at the end of the first induction cycle and the percentage of patients achieving CR with no evidence of minimal residual disease (Day 42).
- According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is January 2020.
- Quizartinib, acquired via the September 2014 acquisition of Ambit Biosciences, is a small molecule inhibitor of FLT3-ITD (FMS-like tyrosine kinase-3-internal tandem duplication), a growth driver of abnormal cells that contributes to the development of AML. It has Orphan Drug status in the U.S. and Europe.