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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

ed alive for more than 12 months
  • The most common treatment-emergent AEs were nausea (53 percent), diarrhea (42 percent), fatigue (39 percent), febrile neutropenia (38 percent), vomiting (37 percent), anemia (31 percent) and QT interval prolongation (27 percent). There was one occurrence of Grade 4 QT prolongation with torsade de pointes, which resolved after stopping quizartinib.  QT interval prolongations were asymptomatic, transient, and none were fatal. A total of 35 patients (27 percent) experienced an AE resulting in discontinuation of quizartinib, with the most common AE leading to discontinuation being progressive disease. 
  • Overall, responses (CRc) were achieved in over 50 percent of elderly patients with the FLT3-ITD mutation. These responses are clinically meaningful given they allowed some patients to be bridged to a stem cell transplant, and others remained alive for more than 12 months (all but one patient did not receive a HSCT). Additionally, nearly one-in-three patients without the FLT3-ITD mutation responded to quizartinib and may also benefit from its future use. Quizartinib is well tolerated, with gastrointestinal toxicities being the most common as well as reversible QT prolongation which was infrequently grade 3, with one case of Grade 4 QT prolongation, at the doses used in this trial. These data suggest that quizartinib may be an option for achieving leukemic control for elderly AML patients that no longer respond, or are refractory, following front-line chemotherapy. For a percentage of elderly AML patients who can tolerate a HSCT, quizartinib may be able to provide a bridge to potentially curative HSCT.  For those who are not HSCT candidates, prolonged quizartinib use may positively impact quality of life given its outpatient delivery.
  • Final Results of a Phase 2 Open-Label, Monotherapy Efficacy and Safety Study of Quizartinib (AC220) in Patients with FLT3-ITD Positive or Negative Relaps
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