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December 9, 2013
19:16 EDTAMBIAmbit Biosciences presents data on quizartinib at ASH Conference
Ambit Biosciences announced four oral presentations given at the 55th Annual ASH Conference in New Orleans, with data highlighting the company's lead drug candidate, quizartinib. The first presentation determined the next steps for quizartinib include a global phase 3 randomized study of quizartinib in FLT3-ITD(+) patients in 1st relapse planned to start in early 2014 pending final FDA feedback on the recommended starting dose. The second presentation said that combining quizartinib with standard chemotherapy is feasible in older patients at a dose of 40mg for 14 days with multiple rounds of chemotherapy, and the next step is to incorporate quizartinib into the MCRI AML-18 trial with a maintenance component to assess efficacy of quizartinib in elderly newly diagnosed AML patients. The third presentation said that the data from this Phase 1 study demonstrated that quizartinib was well tolerated with induction and/or consolidation chemotherapy in newly diagnosed younger adults with AML, and based on these findings, follow-on studies in newly diagnosed AML patients are planned. The fourth presentation concluded that quizartinib was well tolerated at 60mg/m2 in combination with chemotherapy in pediatric patients with relapsed ALL or AML, and responses were encouraging especially in those with FLT3 ITD positive relapsed AML, and further studies in pediatric patients are warranted.
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