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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

ATLANTA, Dec. 10, 2012 /PRNewswire/ -- Astellas Pharma Inc. (Tokyo: 4503, Astellas) and Ambit Biosciences Corporation announced today that the results from a completed Phase 2 study with the investigational FLT3 inhibitor, quizartinib (AC220), as an oral monotherapy treatment regimen in patients with relapsed or refractory acute myeloid leukemia (AML) were presented at the 54th Annual Meeting of the American Society of Hematology (ASH).

The Phase 2 ACE study recruited patients into two separate cohorts of patients with relapsed/refractory AML, and the results from each cohort of were presented in individual oral sessions.  Highlights of the combined key findings in FLT3-ITD positive patients were as follows:

  • Approximately 50 percent of FLT3-ITD positive patients achieved a CRc, or composite complete response (CRc: complete remission (CR) + complete remission with incomplete platelet recovery (CRp) + complete remission with incomplete hematologic recovery (CRi)),
  • Approximately 50 percent of FLT3-ITD positive patients who were refractory (i.e. had no response to their prior AML therapy) achieved a CRc,
  • Approximately one-in-three FLT3-ITD positive patients who had relapsed or were refractory after two prior lines of treatment or after a prior hematopoietic stem cell transplant (HSCT) received a potentially curative HSCT following treatment with quizartinib,
  • As of Sept. 28, 2012, 35 (18 percent) FLT3-ITD positive patients had survival of greater than 12 months

"AML is amongst the most challenging hematological malignancies to treat, and patients with activating FLT3 mutations have a particularly poor prognosis and often relapse or are refractory to current treatment options," said 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.  "
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