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Ambit Announces Presentations At The 55th Annual Meeting Of The American Society Of Hematology (ASH)
Date:12/9/2013

SAN DIEGO, Dec. 9, 2013 /PRNewswire/ -- Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced four oral presentations given at the 55th Annual ASH Conference in New Orleans, with data highlighting the Company's lead drug candidate, quizartinib. 

Results of the Phase 2b Randomized, Open-Label, Study of Lower Doses of Quizartinib in Subjects with FLT3-ITD Positive Relapsed Acute Myeloid Leukemia (AML): The purpose of this study is to assess the efficacy and safety of lower doses of quizartinib in the treatment of patients 18-years or older with relapsed/refractory FLT3 ITD positive AML to further improve the benefit:risk assessment of quizartinib.

This preliminary analysis is based on data available through May 28, 2013 with a minimum of eight weeks of follow up since the last subject first visit.  A total of 76 patients were enrolled from May 21, 2012 to March 27, 2013.  Median age for all patients was 55 (19-77) and 92% were FLT3-ITD(+).  35 patients remained in follow-up at the time of the analysis, and are currently censored for overall survival.  The following key information was presented:

For dose of 30mg:

  • The CRc rate was 47 percent (5 percent CR+CRp, 42 percent CRi)
  • The rate of HSCT after quizartinib use was 32 percent
  • The median overall survival was 20.7 weeks, with 16/38 patients censored as they remained in follow-up at the time of the analysis
  • Of the 12 patients who were bridged to HSCT, the median overall survival was 31 weeks
  • Grade 2 or greater QT prolongation was 11%, with a 5% grade 3 rate and no grade 4 events
  • For dose of 60mg:

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