By: Kerri Fitzgerald
The phase 3 QuANTUM-Wild study is assessing the use of quizartinib plus standard induction/consolidation chemotherapy and maintenance therapy in newly-diagnosed patients with FLT3-ITD-negative acute myeloid leukemia (AML).
Harry Paul Erba, MD, PhD, of the Duke Cancer Institute, presented details of the ongoing global study during the 2025 ASCO(R) Annual Meeting.
The study will enroll approximately 700 patients aged 18 to 70 years with FLT3-ITD allelic frequency <5% through 2028. Treatment includes standard induction with cytarabine and an anthracycline plus quizartinib or placebo, followed by up to four cycles of consolidation with high-dose cytarabine and quizartinib or placebo (with or without allogeneic hematopoietic stem cell transplantation), then single-agent maintenance with quizartinib or placebo in 28-day cycles for up to 36 cycles. Patients will be randomized 2:2:1 into three arms:
- Arm A: Quizartinib in all phases
- Arm B: Placebo in all phases
- Arm C: Quizartinib in induction/consolidation and placebo in maintenance
Quizartinib is administered at 60 mg/day and can be reduced to 30 mg if combined with strong CYP3A inhibitors.
The primary endpoint is overall survival (OS), while secondary endpoints are event-free survival, relapse-free survival, complete remission rate and duration, measurable residual disease, and safety.
Quizartinib, an oral, selective, type-II FLT3 inhibitor, is approved for patients with FLT3-ITD-positive newly-diagnosed AML based on the QuANTUM-First trial. Pre-clinical and clinical studies indicate quizartinib may have activity in FLT3-ITD-negative AML. Results from the phase 2 QUIWI trial showed that adding quizartinib to standard chemotherapy and as single-agent maintenance significantly prolonged OS in these patients.
Daiichi Sankyo is sponsoring the study.
Reference
Montesinos P, Cheong JW, Daver N, et al. QuANTUM-Wild: a phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3-ITD–negative acute myeloid leukemia (AML). Abstract TPS6580. Presented at the 2025 ASCO(R) Annual Meeting;; May 30-June 3, 2025; Chicago.
