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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

e 2 ACE Study Design
This open-label Phase 2 trial included a total of 333 patients with relapsed or refractory AML. Data from 271 patients were reported here from the "confirmatory" phase of the study.  Data from 62 patients from an "exploratory" phase had been reported earlier.  In the "confirmatory" phase, quizartinib was investigated in two separate cohorts, and each of these cohorts was presented in separate oral sessions this week:

  • Cohort 1: Patients who are 60 years of age or older who are relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first remission of less than 12 months duration or are primary refractory to first-line chemotherapy
  • Cohort 2: Patients who are 18 years of age or older, including patients 60 years of age or older, who are relapsed or refractory after one second-line (salvage) regimen or are relapsed or refractory after HSCT

Quizartinib was administered orally, once-a-day, at a starting dose of 90 mg/day (females) or 135 mg/day (males), in 28-day treatment cycles until disease progression, elective HSCT or unacceptable toxicity that could not be mitigated with dose adjustments.  The co-primary endpoints were CRc (CR + CRp + CRi) and CR.   Additionally, partial response (PR), overall survival (OS), HSCT rates, molecular pharmacodynamic (PD) biomarkers and standard safety assessments were evaluated. 

Final Results of a Phase 2 Open-Label, Monotherapy Efficacy and Safety Study of Quizartinib (AC220) in Patients ≥ 60 Years of Age with FLT3-ITD Positive or Negative Relapsed/Refractory Acute Myeloid Leukemia (Abstract #43)
Jorge Cortes, M.D., Internist and Professor, Deputy Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

Data through Sept. 28, 2012 (representing at least 10 months of follow-up f
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