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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

CRi),
  • The median duration of CRc was 7.0,weeks, which was likely impacted by a high percentage (37 percent) of patients who were bridged to a HSCT,
  • An additional 16 percent of patients achieved a PR,
  • Of those refractory to their last AML therapy, 48 percent achieved at least a PR with quizartinib,
  • The rate of HSCT after quizartinib use was 37 percent, which represents clinical benefit in this heavily pretreated patient population,  
  • The median overall survival was 25.6 weeks,
  • Ten patients (26 percent) are considered "long-term survivors" given they remained alive for more than 12 months
  • The most common treatment-emergent AEs were nausea (53 percent), vomiting (41 percent), febrile neutropenia (38 percent), diarrhea (37 percent), anemia (34 percent), QT interval prolongation (27 percent) and fatigue (24 percent).  QT interval prolongations were asymptomatic, transient, and there were no Grade 4 events or deaths associated with QT prolongation. A total of 25 patients (18 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 46 percent of heavily pretreated patients with the FLT3-ITD mutation. These responses are clinically meaningful given they allowed a high percentage (37 percent) of  patients to be bridged to a stem cell transplant, and 23 percent of the FLT3-ITD positive patients remained alive for more than 12 months (of which 61 percent received a HSCT). The potential impact of bridge to HSCT was shown in the median overall survival for patients with the FLT3-ITD mutation which was 33.3 weeks for those who had a subsequent HSCT, compared to 17.7 weeks in those patients with the FLT3-ITD mutation who did not receive a subsequent HSCT.  Nearly one-in-three patients without the FLT3-ITD mutation also responded to qui
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