TOKYO, May 30, 2015 /PRNewswire/ -- Astellas Pharma
Inc. (TSE: 4503) today announced that preliminary data from a Phase
1/2 trial on the safety, tolerability and efficacy of ASP2215, a
selective inhibitor of FLT3/AXL, in patients with relapsed or
refractory (R/R) acute myeloid leukemia (AML) were presented during
an oral abstract session at the American Society of Clinical
Oncology's (ASCO) annual meeting in Chicago.
ASP2215 is a receptor tyrosine kinase inhibitor of FLT3 and AXL,
which are involved in the growth of cancer cells. ASP2215
demonstrated inhibitory activity against FLT3 internal tandem
duplication (ITD) as well as tyrosine kinase domain (TKD), two
common types of FLT3 mutations that are seen in up to one third of
patients with AML. Preliminary data from the Phase 1/2 trial
demonstrated a 57.5 percent overall response rate and a 47.2
percent composite Complete Response (CR) rate (CR + CR with
incomplete platelet recovery + CR with incomplete hematologic
recovery) in 106 patients with FLT3 mutations who received 80 mg
and higher doses. Furthermore, median duration of response was 18
weeks across all doses and median overall survival was
approximately 27 weeks at 80 mg and above in FLT3 mutation positive
patients. A plasma inhibitory activity assay also confirmed
sustained FLT3 inhibition consistently in patients receiving doses
of 80 mg and above.
The ASP2215 Phase 1/2 trial design followed a 3+3 escalation and
evaluated doses from 20 to 450 mg once daily. A parallel multi-dose
expansion cohort was initiated based on the efficacy seen in dose
escalation. A total of 198 patients were enrolled in the study: 24
in the dose escalation and 174 in the dose expansion cohorts. At
the 450 mg dose, two patients reached dose-limiting toxicity (grade
3 diarrhea and ALT/AST elevation) and the maximum tolerated dose
was determined to be 300 mg.
"ASP2215 demonstrated the ability to inhibit the FLT3 mutation
that is seen in approximately 30 percent of AML patients," said
Mark J. Levis, M.D., Ph.D.,
Department of Oncology, Sidney Kimmel Comprehensive Cancer Center,
Johns Hopkins University.
"At Astellas Oncology, we are focused on developing targeted
therapies for hard-to-treat cancers with few therapeutic options,
such as AML," said Claire Thom,
Pharm.D., senior vice president and oncology therapeutic head,
Astellas Pharma Global Development, Inc. "We are very excited about
these results as they indicate that ASP2215 may be a therapeutic
option in this underserved patient population. We look forward to
moving this candidate into Phase 3 trials to further explore the
full potential of the compound for patients suffering from
AML."
A randomized Phase 3 trial of ASP2215 at 120 mg per day in
relapsed and refractory AML patients is planned. For more
information, visit
https://clinicaltrials.gov/ct2/show/NCT02421939.
ASP2215 was discovered through a research collaboration with
Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive
global rights to develop, manufacture and potentially commercialize
ASP2215.
About Acute Myeloid Leukemia
Acute myeloid leukemia is
a cancer that impacts the blood and bone marrow and most commonly
experienced in older adults. According to the American Cancer
Society, in 2015, there will be an estimated 20,830 new cases of
AML diagnosed in the United
States, and about 10,460 cases will result in
death.
About Astellas
Astellas is a pharmaceutical company
dedicated to improving the health of people around the world
through provision of innovative and reliable pharmaceuticals. For
more information on Astellas, please visit our website
at www.astellas.us, follow us on Twitter
at www.twitter.com/AstellasUS or like our Facebook page
at www.facebook.com/AstellasUS.
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SOURCE Astellas Pharma Inc.