EHA 2023 | MORPHO: gilteritinib as post-transplant maintenance therapy in patients with FLT3-ITD AML

The BTM-CTN 1506 (MORPHO; NCT02997202) study is a Phase III randomized trial that highlights the potential of gilteritinib as a post-transplant maintenance therapy for patients with acute myeloid leukemia (AML) carrying an internal tandem duplication mutation of FLT3 (FLT3-ITD). The study aimed to investigate whether gilteritinib could improve relapse-free survival (RFS) compared to a placebo for patients transplanted in their first remission, and determine whether measurable residual disease (MRD) can be used to guide who should be treated with post-transplant gilteritinib. The analysis showed that patients receiving gilteritinib had a higher two-year RFS compared to placebo, although the difference was not statistically significant. Gilteritinib had a more pronounced effect on patients with detectable MRD, suggesting its potential benefit for this subgroup. The MORPHO study is among the first to demonstrate prospectively a correlation between MRD, RFS, and overall survival (OS) in patients with FLT3-ITD AML treated with post-transplant maintenance and suggests that post-transplant gilteritinib should be a standard of care (SOC) in patients who are MRD-positive pre- or post-transplant. This press briefing took place at the European Hematology Association (EHA) Congress 2023, held in Frankfurt, Germany.

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