First Dose of Quizartinib Administered in QuANTUM-Wild Phase III Trial

The first dose of quizartinib has been administered in the QuANTUM-Wild phase III trial of quizartinib (VANFLYTA®) plus standard intensive induction and consolidation chemotherapy with subsequent single-agent maintenance for adults with newly diagnosed acute myeloid leukemia (AML) without FLT3-ITD mutation, according to a press release from Daiichi Sankyo.

“Preliminary data have shown promising results for VANFLYTA in patients with FLT3-ITD negative AML, which includes patients without FLT3 mutations and patients with TKD mutations,” said Mark Rutstein, MD, global head of Oncology Clinical Development at Daiichi Sankyo, in the release.

The QuANTUM-Wild trial was designed following positive findings in the phase II QUIWI trial. QUIWI’s data suggested the addition of quizartinib to standard intensive chemotherapy prolonged overall survival in a cohort of 273 patients, according to the final data update at the 66th American Society of Hematology Annual Meeting & Exposition.

In QuANTUM-Wild, two treatment arms will receive either quizartinib or placebo with standard induction and consolidation therapy followed by up to three years of quizartinib maintenance. A third, exploratory treatment arm will evaluate quizartinib with standard chemotherapy followed by placebo maintenance.

The planned enrollment is approximately 700 adult patients aged 18 to 70 years with newly diagnosed FLT3-ITD–negative AML. The primary endpoint is overall survival, while secondary endpoints include event-free survival, duration of complete response, relapse-free survival, complete remission rate (CR), CR with measurable residual disease negativity, pharmacokinetics, and safety.