Quizartinib for Newly Diagnosed <i>FLT3</i>-Internal Tandem Duplication-Negative AML: The Randomized, Double-Blind, Placebo-Controlled, Phase II QUIWI Study.

ABSTRACT:

Purpose

Quizartinib, an oral, selective, second-generation, type-II FMS-like tyrosine kinase 3 (FLT3) inhibitor with high binding affinity to internal tandem duplication (ITD) and wild-type (WT) FLT3, has shown early clinical activity as monotherapy in patients with relapsed/refractory FLT3-ITD-negative AML. The phase III QuANTUM-First trial showed that quizartinib significantly prolonged survival versus placebo when added to standard chemotherapy, followed by single-agent maintenance, in patients with newly diagnosed (ND) FLT3-ITD-positive AML. We investigated the safety and efficacy of quizartinib in patients with ND FLT3-ITD-negative AML.

Methods

The phase II, randomized, double-blind, placebo-controlled QUIWI trial enrolled patients age 18-70 years w

SUBMITTER: Montesinos P 

PROVIDER: S-EPMC12736402 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature