The MORPHO trial enrolled 356 patients with FLT3-ITD AML. Credit: Julia Koblitz on Unsplash.

Astellas Pharma, along with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), has unveiled results from the Phase III MORPHO clinical trial that studied gilteritinib as a maintenance therapy after allogeneic hematopoietic stem cell transplantation (HSCT) in FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukaemia (AML) patients.

Data from the randomised, double-blind, placebo-controlled, multi-centre trial demonstrated benefit in these patients’ subgroups.

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However, the data did not show statistically significant relapse-free survival (RFS) improvement in the full cohort.

Clinical improvement of RFS in a subgroup of patients with detectable measurable residual disease (MRD) in comparison with patients without detectable MRD was also reported.

In exploratory evaluation, gilteritinib demonstrated favourable RFS for 50% of patients with detectable MRD pre- or post-HSCT as against those without detectable MRD.

Furthermore, RFS in the North American sub-group showed a 0.397 hazard ratio (HR) for gilteritinib compared to placebo.

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The MORPHO trial enrolled 356 patients. It examined gilteritinib in comparison with placebo as maintenance therapy over two years after HSCT in the targeted patients and in remission following induction therapy.

The trial failed to meet its pre-defined RFS primary endpoint and key secondary endpoint of overall survival or patients receiving gilteritinib versus placebo.

In FLT3-ITD AML patients, treatment-emergent adverse events (TEAEs) related to gilteritinib versus placebo were decrease in neutrophil and increased incidence of chronic graft-versus-host disease.

Astellas Pharma senior vice-president and Oncology Development head Ahsan Arozullah said: “While we are continuing to conduct a thorough assessment of the full data set from our Phase III MORPHO trial, we are encouraged by these data which explore the potential of gilteritinib in a maintenance setting.

“AML patients with a FLT3-ITD mutation often face worse outcomes than those with other mutations and have restricted post-HSCT treatment options with unmet need.

“With these findings, we remain focused on sharing updates with the scientific community to inform continued innovation for the AML community.”