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Press Release

First Patient Dosed in Phase 3 MORPHO Trial Evaluating Gilteritinib as Maintenance Therapy Following Hematopoietic Stem Cell Transplant in Patients with FLT3 Mutation-positive Acute Myeloid Leukemia

Astellas Pharma
Posted on: 24 Aug 17

TOKYO – August 22, 2017 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the first patient was dosed in the registrational Phase 3 MORPHO trial of gilteritinib, the fourth Phase 3 trial underway in the gilteritinib clinical development program. The MORPHO trial is a randomized, double-blind, placebo-controlled, multi-center trial that compares gilteritinib to placebo as maintenance therapy over a period of two years following hematopoietic stem cell transplant (HCT) in patients with FLT3 internal tandem duplication (ITD) mutation-positive (FLT3/ITD+) acute myeloid leukemia (AML) and in remission after induction therapy. The primary endpoint is relapse-free survival (RFS), and the study is being conducted in collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).


“We know that FLT3+ AML patients face potentially worse outcomes than those with other mutations, and while some patients may experience remission following a stem cell transplant, many unfortunately relapse,” said trial investigator and BMT CTN Study co-chair Mark J. Levis, M.D., Ph.D., of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. “Given this reality, it is exciting to study gilteritinib in patients following a stem cell transplant.”


Gilteritinib has demonstrated inhibitory activity against FLT3 ITD as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one third of patients with AML. Further, gilteritinib has also demonstrated inhibition of AXL, which is reported to be associated with therapeutic resistance.


AML is a cancer that impacts the blood and bone marrow and is most commonly experienced in older adults. According to the American Cancer Society, in 2016 there were an estimated 21,000 new cases of AML diagnosed in the United States and about 10,600 cases resulted in death.


"The initiation of the MORPHO trial is another significant milestone for Astellas and for patients as therapeutic options can be very limited for this FLT3+ AML population,” said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. “We are committed to patients with FLT3+ AML and currently have underway four Phase 3 trials to explore the potential benefit of gilteritinib for patients suffering from such an aggressive form of blood cancer characterized by both genetic and resistance mutations.”


Astellas is currently investigating gilteritinib in various AML patient populations through several Phase 3 trials, including the registrational ADMIRAL trial in relapsed/refractory FLT3+ AML.


The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release are not intended to constitute an advertisement or medical advice.

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Editor's Details

Mike Wood

Last updated on: 24/08/2017

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