Phase II success for Astellas in AML study
Astellas Pharma Inc. and Ambit Biosciences Corporation announced that the results from a completed Phase II 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 II 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.
see 1) "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) Prof. Jorge Cortes, M.D.,Internist and Deputy Chairman, Department of Leukemia, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas https://ash.confex.com/ash/2012/ webprogram/Paper53990.html and "Final Results of a Phase 2 Open-Label, Monotherapy Efficacy and Safety Study of Quizartinib (AC220) in Patients with FLT3-ITD Positive or Negative Relapsed/Refractory Acute Myeloid Leukemia After Second-Line Chemotherapy or Hematopoietic Stem Cell Transplantation." (Abstract #673) Dr. Mark Levis, Associate Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland https://ash.confex.com/ash/2012/ webprogram/Paper54037.html.
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