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Ambit and Astellas Announce Presentation of Results from Phase 2 ACE Study of Quizartinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) at the 54th Annual Meeting of the American Society of Hematology
Date:12/10/2012

The findings from the Phase 2 ACE study with quizartinib in patients with relapsed and refractory AML are especially encouraging.  In the patients with the FLT3-ITD mutation, quizartinib represents the most active single-agent we have observed with any class of investigational drugs in this challenging patient population.  We look forward to further investigation of quizartinib in the expanding clinical program which includes multiple treatment strategies and subpopulations of AML patients".

In addition to the clinical benefit observed in FLT3-ITD positive patients, there was substantial evidence of activity in FLT3-ITD negative patients, with approximately one-in-three of these patients achieving a CRc and a comparable percentage receiving HSCT as in the FLT3-ITD positive group.

Safety findings in the study were primarily gastrointestinal, myelosuppression and QT prolongation, and these were generally mitigated with dose modifications.  Twenty-two percent of patients experienced an adverse event (AE) that resulted in treatment discontinuation, with progressive disease being the most common AE.

"The results of this large Phase 2 ACE trial demonstrate the clinical benefit achieved with quizartinib in heavily pretreated AML patients with limited therapeutic options," said Athena Countouriotis, M.D., Chief Medical Officer of Ambit.  "A substantial portion of patients who relapsed or were refractory to two prior lines of treatment, or a prior HSCT, were successfully bridged to HSCT, which is considered the only potentially curative procedure for patients diagnosed with AML.  For those patients who are not eligible for HSCT, prolonged quizartinib use may positively impact quality of life as an outpatient treatment.  Further, these results showed a safety and tolerability profile comparable with what was observed in an early study, but with a lower rate of asymptomatic Grade 3 QT prolongation."

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SOURCE Ambit Biosciences
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