Clinical Trials

Date: 2017-08-21

Type of information: Treatment of the first patient

phase: 3

Announcement: treatment of the first patient

Company: Astellas Pharma (Japan)

Product: gilteritinib

Action mechanism:

kinase inhibitor/tyrosine kinase inhibitor/FLT3 inhibitor/AXL inhibitor. Gilteritinib is a receptor tyrosine kinase inhibitor of FLT3 and AXL, which are involved in the growth of cancer cells. Gilteritinib has 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 acute myeloid leukemia.
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical and Astellas has exclusive global rights to develop, manufacture and potentially commercialize gilteritinib.
Astellas is currently investigating gilteritinib in various acute myeloid leukemiapatient populations through several Phase 3 trials, including the registrational ADMIRAL trial in relapsed/refractory FLT3+ acute myeloid leukemia.

Disease: acute myeloid leukemia with FLT3 internal tandem duplication (ITD) mutation-positive (FLT3/ITD+)

Therapeutic area: Cancer - Oncology

Country: Japan, Republic of Korea, Poland, Spain

Trial details:

The Phase 3 MORPHO Study is a two-arm, randomized, double-blind, placebo-controlled, multi-center trial in 346 patients with a diagnosis of AML harboring a FLT3/ITD mutation. Participants must be in first complete remission prior to transplant, as defined by less than five percent blasts in the bone marrow with no morphologic characteristics of acute leukemia in the bone marrow with no evidence of extra-medullary leukemia. After undergoing transplantation, participants will be randomized to receive gilteritinib (120 mg) or placebo beginning after the time of engraftment for a two-year period. Participants will be stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced intensity), 2) time from hematopoietic stem cell transplant to randomization (30-60 days vs. 61-90 days) and 3) presence or absence of minimal residual disease from the most recent pre-registration bone marrow aspirate. The primary endpoint of the trial is relapse-free survival. (NCT02997202).

Latest news:

• On August 21, 2017, Astellas Pharma announced 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 in patients with FLT3 internal tandem duplication (ITD) mutation-positive (FLT3/ITD+) acute myeloid leukemia and in remission after induction therapy. The study is being conducted in collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).