Phase II study success of quizartinib (Astellas/Ambit Bioscience) in AML

Astellas Pharma Inc. and Ambit Biosciences Corporation announced 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). Data from two study cohorts (patients aged ? 60 years with AML relapsed in <1 year or refractory to 1st-line chemotherapy patients aged 18 years with aml relapsed or refractory to second line salvage chemotherapy or relapsed after hsct were presented at the american society of haematology ash meeting.>

Approximately 50 percent of FLT3-ITD positive patients achieved a composite complete response (CRc = complete remission (CR) + complete remission with incomplete platelet recovery (CRp) + complete remission with incomplete hematologic recovery (CRi))� Additionally, around one in three FLT3-ITD positive patients in the cohort that were heavily pre-treated (i.e. had relapsed or were refractory after two prior lines of treatment or after a prior HSCT) received a potentially curative HSCT following treatment with quizartinib. In addition to the clinical benefit observed in FLT3-ITD positive patients, these data demonstrated substantial evidence of activity in FLT3-ITD negative patients, with approximately one in three patients achieving a CRc and a comparable percentage receiving HSCT as in the FLT3-ITD positive group.

see "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 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) Mark Levis, M.D., PhD, 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.