Final Results of Quiwi: A Double Blinded, Randomized Pethema Trial Comparing Standard Chemotherapy Plus Quizartinib Versus Placebo in Adult Patients with Newly Diagnosed FLT3-ITD Negative AML
Abstract
Background: Inhibition of FLT3 and other kinases through oral targeted agents could improve standard chemotherapy outcomes for fit AML FLT3-ITD negative patients. The randomized SORAML trial from the SAL group, including all genetic subtypes, showed that the addition of type II inhibitor sorafenib improved leukemia-free, but not overall survival (OS) among newly diagnosed fit AML patients. Quizartinib (Quiz) is a potent type II inhibitor showing about 30% of complete remissions (CR) and CR with incomplete recovery (CRi) as monotherapy for relapsed/refractory FLT3-ITD negative AML. With this rationale, the PETHEMA group designed a randomized, double-blind, placebo (PBO)-controlled phase II QUIWI trial (NCT04107727), with interim preplanned analyses (data cut-off March 2023) reporting 2-years overall survival (OS) 63.5% with Quiz vs. 47% with PBO (p=0.004). Here, we report the final analyses of the QUIWI trial with significantly prolonged follow-up (data cut-off July 26th, 2024) and full data-base cleaning.
Methods: Multicenter, randomized, PBO-controlled, double-blinded phase II clinical trial. Patients with newly diagnosed FLT3-ITD negative AML, aged 18 to 70 years, and fit for intensive chemotherapy were centrally screened for FLT3-ITD prior to randomization. The trial was conducted in two phases: an open-label safety run-in phase exploring Cytarabine 200 mg/m2 (days 1-7), Idarubicin 12 mg/m2 (days 1-3), and Quiz 60 mg/d x 14 days to establish the dose for the randomized…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 180 participants or records.
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