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Ambit and Astellas Announce Results From Multiple Quizartinib Presentations at the 53rd Annual Meeting of the American Hematology Society
Date:12/13/2011

ients included in the analysis were either at least 60 years old and relapsed or refractory to first-line chemotherapy (Cohort 1, N=26), or at least 18 years old and relapsed or refractory to second-line chemotherapy or HSCT (Cohort 2, N=36).  The results from an earlier data cut of this patient subset were presented earlier this year at the European Hematology Association Meeting in London.  The study has now completed enrollment and results for the total study population are expected in 2012.

The co-primary end points of the study are composite complete remission (CRc) rate and complete remission (CR) rate in the first 84 days.  CRc is defined as the sum of complete remission, complete remission with incomplete platelet recovery (CRp), and complete remission with incomplete hematologic recovery (CRi).  In this updated interim analysis on 62 patients there were composite complete response (CRc) rates of 40 percent, 46 percent and 36 percent in all patients, Cohort 1 and Cohort 2, respectively.   The majority of CRc cases were CRi.  Notably, a CRc rate of 55 percent was achieved in patients who were refractory to the prior line of treatment (N=20).  Key secondary end points in the study include duration of remission, rates of partial response, and overall survival.  The median duration of response for patients achieving a CRc was 12.1, 14.3, and 10.1 weeks in all patients, Cohort 1 and Cohort 2, respectively, with patients censored at the time of transplant.  The median overall survival was 25.4, 24.1, and 26.9 weeks for all patients, Cohort 1, and Cohort 2, respectively.  An analysis of survival across all patients demonstrated that patients with a CRc had a 41 percent improved median survival versus non-responders, with durations of 34.1 and 24.2 weeks, respectively.

The most common treatment-related adverse events in the study included nausea, vomiting, fatigue and febrile neutropenia.  Sev
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