Astellas and BMT CTN Report P-III Trial (MORPHO) Results of Gilteritinib for the Treatment of Acute Myeloid Leukemia
- The P-III trial (MORPHO) evaluating gilteritinib (120mg) as a maintenance therapy vs PBO following allogeneic HSCT in 356 patients with a diagnosis of AML harboring an FLT3/ITD mutation across North America, EU & Asia-Pacific region, incl. Japan. The study was conducted in collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
- The study failed to meet its pre-defined 1EPs of RFS. The results will be submitted for publication and at upcoming medical meetings
- Gilteritinib is an FMS-like tyrosine kinase 3 inhibitor & showed activity against FLT3-ITD. The therapy was available as Xospata in the US, Japan, China & selected EU countries for adult patients who have r/r FLT3+ AML
Ref: Astellas | Image: Astellas
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