QUIWI: First results suggest a clinical benefit of quizartinib in AML

Preliminary results of the QUIWI study indicate that the addition of quizartinib to the ‘3+7’ regimen may prolong survival in untreated patients without internal tandem duplications of the FLT3 gene (FLT3-ITD  wildtype) acute myeloid leukaemia (AML).

The addition of quizartinib, a selective FLT3 inhibitor, to standard chemotherapy with or without allogeneic hematopoietic cell transplant, improved overall survival in AML patients with FLR3-ITD mutations [1]. The current phase 2 QUIWI trial (NCT04107727) the effectiveness of quizartinib in FLT3-ITD wildtype AML by randomising 273 participants with untreated FLT3-ITD wildtype AML 2:1 to ‘3+7’ plus FLT3 inhibitor quizartinib, or ‘3+7’ plus a placebo [2]. In the experimental arm, quizartinib was administered during induction, consolidation, and maintenance therapy.  The primary endpoint was event-free survival (EFS). Dr Pau Montesinos (University of Valencia, Spain) presented the findings of a preplanned interim analysis.

After a median follow-up of 17 months, the median EFS was 16.6 months in the quizartinib arm and 10.6 months in the placebo arm (HR 0.73; 95% CI 0.52–1.02; P=0.062). The median overall survival (OS) was not reached in the quizartinib arm and 15.0 months in the placebo arm (HR 0.56; P=0.004). Corresponding 2-year OS rates were 63.5% and 47.0% for quizartinib and placebo, respectively. Disease-free survival was not reached in the quizartinib arm versus 15.4 months in the placebo arm (HR 0.64; P=0.050).

These findings suggest that quizartinib, on top of standard chemotherapy, may improve EFS and OS even in patients with newly diagnosed FLT3-ITD wildtype AML.

 

1. Erba H, et al. Lancet. 2023;401(10388):1571–1583.
2. Montesinos P, et al. Preliminary results of QUIWI: a double blinded, randomized clinical trial comparing standard chemotherapy plus quizartinib versus placebo in adult-patients with newly diagnosed FLT3-ITD wild-type AML. Novel combinations in the treatment of AML, EHA 2023 Annual Congress, 8─11 June, Frankfurt, Germany.

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Posted on 2 August 202327 March 2024