Astellas Pharma Releases Phase II Data For Leukemia Drug
Tech & Pharma
December 12, 2012
Approximately 50 percent of FLT3-ITD positive AML patients achieved complete remission with Astellas Pharma’s new investigational drug, according to Phase II data results.
AsianScientist (Dec. 12, 2012) – Approximately 50 percent of FLT3-ITD positive AML patients achieved complete remission with Astellas Pharma’s new investigational drug, according to completed Phase II data results.
Quizartinib (AC220) is an orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor being developed in collaboration between Ambit Biosciences Corporation and Astellas Pharma Inc. as an oral monotherapy treatment regimen in patients with relapsed or refractory acute myeloid leukemia (AML).
Data from two study cohorts were presented at the American Society of Haematology (ASH) meeting in Atlanta, Georgia.
Combined results from the two cohorts (patients aged ≥ 60 years with AML relapsed within one year or refractory to first-line chemotherapy; patients aged ≥ 18 years with AML relapsed or refractory to second line, salvage chemotherapy or relapsed after HSCT) indicate that approximately 50 percent of FLT3-ITD positive patients achieved a complete response (complete remission, complete remission with incomplete platelet recovery, and complete remission with incomplete hematologic recovery).
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.
“AML is among 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 Dr. Jorge Cortes, the University of Texas M.D. Anderson Cancer Center.
AML is considered to be the most common form of myeloid leukemia in adults, affecting between 5 and 8 people in every 100,000 in Europe. Overall mortality is high (between 4 and 6 in every 100,000).
Mutations of FLT3 have been detected in approximately 30 percent of AML patients; 24 percent of these mutations have been found to be internal tandem duplication (ITD) mutations. Patients with FLT3 mutations tend to have a poor prognosis.
This open-label Phase II trial included a total of 333 patients with relapsed or refractory AML. Data on 271 patients was reported here from the “confirmatory” phase of the study. Data on 62 patients from an “exploratory” phase has been reported earlier.
In the “confirmatory” phase, quizartinib was administered orally, once-a-day, at a starting dose of 90 mg/day (females) or 135 mg/day (males), in 28-day treatment cycles until disease progression, or unacceptable toxicity that could not be mitigated with dose adjustments. The primary end point was a complete response.
Quizartinib is currently under evaluation in a Phase IIb clinical trial as monotherapy treatment for adult patients with relapsed or refractory AML, and in two Phase I studies in a combination treatment regimen with chemotherapy, and as a maintenance therapy following transplant, respectively.
Source: Astellas Pharma.
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