Phase III trial of Vanflyta for FLT3-ITD negative AML

This trial was started based on results of the QUIWI phase II trial evaluating Vanflyta in combination with standard intensive chemotherapy and as subsequent maintenance monotherapy in adult patients with newly diagnosed FLT3-ITD negative AML. The final results of QUIWI were presented at the 2024 American Society of Hematology Annual Meeting. 

QuANTUM-Wild (NCT06578247) is a randomized, double-blind, placebo-controlled global phase III trial evaluating the efficacy and safety of Vanflyta  in combination with standard intensive induction and consolidation therapy, including allogenic hematopoietic stem cell transplant (HSCT), followed by maintenance monotherapy, in adult patients aged 18 to 70 with newly diagnosed FLT3-ITD negative AML. Patients will be randomized 2:2:1 into three treatment arms. In Arms A and B, patients will receive Vanflyta  or placebo, respectively, in combination with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by up to three years of single-agent maintenance therapy. The primary endpoint for Arms A and B is overall survival. Secondary endpoints include event-free survival, duration of complete response, relapse-free survival, complete remission rate (CR), CR with minimal or measurable residual disease negativity, pharmacokinetic assessments and safety measures including treatment emergent adverse events. 

For purposes of exploratory analyses in the maintenance setting, patients in a third study arm (Arm C), will receive Vanflyta  in combination with intensive induction and consolidation chemotherapy followed by placebo maintenance monotherapy. QuANTUM-Wild is expected to enroll approximately 700 patients across Asia, Australia, Europe, North America and South America.