Phase III ADMIRAL trial data for Xospata in Acute Myeloid Leukemia published in NEJM.- Astellas

The New England Journal of Medicine has published detailed results from the Phase III ADMIRAL trial, which found that Astellas Pharma Inc.'s Xospata (gilteritinib) demonstrated significantly longer Overall Survival (OS) than salvage chemotherapy in adult patients with relapsed (disease that has returned) or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation. Common adverse events from the study of grade 3 or higher in the gilteritinib group were febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%). The study enrolled 371 patients with relapsed or refractory AML and positive for FLT3 mutations present in bone marrow or whole blood as determined by the central lab. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy. The results appear in the October 31 print edition of the Journal and are currently available online.

See: "Gilteritinib or chemotherapy for relapsed or refractory FLT3-mutated AML." Perl A, Martinelli G, Cortes J, et al. N Engl J Med 2019; 381:1728-40. DOI: 10.1056/NEJMoa1902688

Comment: The FDA approved a supplemental New Drug Application (sNDA) in May of 2019 to update the U.S. product labeling for Xospata to include final analysis OS data from the ADMIRAL trial. Xospata was approved by the Japan Ministry of Health, Labor and Welfare (MHLW) for relapsed or refractory AML with FLT3 mutations and launched as Xospata 40 mg Tablets in 2018.