Frontline Quizartinib Is Tested in AML Subgroup

Angelica Welch
Published: Thursday, Sep 06, 2018
Antoine Yver, MD

Antoine Yver, MD

Patients with acute myeloid leukemia (AML) who harbor a FLT3-ITD mutation historically have had a poor prognosis. Quizartinib, a small molecule receptor tyrosine kinase inhibitor targeting FLT3, has shown promise as a single agent in the relapsed/refractory setting and is currently being evaluated in combination with chemotherapy in patients with newly diagnosed FLT3-ITD–positive AML in the QuANTUM-First study (NCT02668653).1

The global, randomized, double-blind, placebocontrolled, phase III study is comparing quizartinib with standard induction and consolidation chemotherapy with placebo with standard induction and consolidation chemotherapy. Quizartinib is then administered as maintenance therapy alone compared with maintenance with placebo alone. The primary endpoint of QuANTUM-First is eventfree survival, with secondary endpoints of overall survival (OS), complete remission (CR) at the end of the first induction cycle, and composite CR rate after the first induction cycle (Figure).

“The hypothesis is that by adding quizartinib to the standard of care, we would improve the overall outcome of patients,” Antoine Yver, MD, MSc, executive vice president and global head, Oncology Research and Development, Daiichi Sankyo, said in an interview with OncologyLive®.

QuANTUM-First is currently enrolling participants. The experimental arm of the trial consists of up to 2 cycles of induction chemotherapy with cytarabine and daunorubicin or idarubicin followed by quizartinib, up to 4 cycles of consolidation with cytarabine then quizartinib alone or quizartinib and a hematopoietic stem cell transplant (HSCT), and maintenance consisting of up to 12 cycles of quizartinib.

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