Astellas and the Blood and Marrow Transplant Clinical Trials Network Report P-III Trial (MORPHO) Results of Gilteritinib for FLT3-ITD Acute Myeloid Leukemia


The P-III trial evaluating gilteritinib (120mg) as a maintenance therapy vs PBO in 356 patients across North America, the EU & the Asia-Pacific region, incl. Japan
The trial showed favorable results in subgroups of FLT3-ITD mutated AML patients, incl. patients with detectable MRD & also failed to show RFS improvement in the entire cohort, clinical improvement of RFS in a subgroup of patients with detectable MRD (72.4% vs 57.4%) @2yrs.
The exploratory analysis showed a favorable RFS for ~50% of patients with detectable MRD pre- or post-HSCT vs those without detectable MRD, the incidence of chronic GVHD (52.2% vs 42.1%). Gilteritinib is available as Xospata in the US, Japan, China & selected EU countries

Ref: PRNewswire | Image: Astellas

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