TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Thursday said the Phase 3 MORPHO study of gilteritinib in patients with acute myeloid leukemia did not meet its primary endpoint of relapse-free survival (RFS).
MORPHO study evaluated gilteritinib as a maintenance therapy following hematopoietic stem cell transplantation (HSCT) in 356 patients with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML).
Since RFS was not statistically significant at the primary analysis, the study will be stopped, Astellas said.
Gilteritinib is available as XOSPATA in the U.S., Japan, China and selected European countries for the treatment of adult patients who have relapsed or refractory FLT3+ AML.
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