The global trial is anticipated to enrol nearly 700 subjects across North America, South America, Australia, Europe, and Asia. Credit: Volha_R/Shutterstock.
Daiichi Sankyo has announced the dosage of the first subject in the randomised Phase III QuANTUM-Wild trial of oral Vanflyta (quizartinib) in adults with newly diagnosed, FLT3-ITD negative acute myeloid leukaemia (AML).
This trial follows the outcomes of the QUIWI Phase II trial.
The placebo-controlled, double-blind trial aims to assess VANFLYTA in conjunction with standard intensive induction and consolidation therapy, along with allogenic hematopoietic stem cell transplant (HSCT) and post-maintenance monotherapy, in subjects age 18 to 70 years old with the given condition.
The global trial is anticipated to enrol nearly 700 subjects across North America, South America, Australia, Europe, and Asia.
Subjects will be randomised into three treatment arms. Arms A and B will compare the therapy and a placebo, both in conjunction with cytarabine and anthracycline induction, and cytarabine consolidation chemotherapy. This will be followed by up to three years of maintenance therapy with Vanflyta as a single agent.
Overall survival is the primary endpoint for these arms.
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For exploratory purposes, subjects in Arm C are set to receive Vanflyta with induction and consolidation chemotherapy, followed by placebo maintenance monotherapy.
Daiichi Sankyo oncology clinical development global head Mark Rutstein said: “Preliminary data have shown promising results for Vanflyta in patients with FLT3-ITD negative acute myeloid leukaemia, which includes patients without FLT3 mutations and patients with TKD mutations.
“We have initiated the QuANTUM-Wild trial to further confirm the potential role of Vanflyta, combined with standard chemotherapy and as a subsequent maintenance monotherapy, in this broader population of patients with AML, who are in need of new treatment options to potentially reduce the risk of relapse and improve overall survival.”
In September, AstraZeneca and Daiichi Sankyo reported outcomes from the TROPION-Breast01 Phase III clinical trial of datopotamab deruxtecan (Dato-DXd) for breast cancer.
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