Astellas Pharma Inc. announced results from the phase III ADMIRAL clinical trial comparing Xospata (gilteritinib) to salvage chemotherapy in adult patients with relapsed or refractory acute myeloid leukemia with a FLT3 mutation.
The results show that patients treated with Xospata had significantly longer overall survival than those who received standard salvage chemotherapy. The data were shared by Alexander Perl, Abramson Cancer Center, University of Pennsylvania, in a press conference at the American Association for Cancer Research annual meeting.
Results from the ADMIRAL trial show the median OS for patients who received Xospata was 9.3 months compared to 5.6 months for patients who received salvage chemotherapy (Hazard Ratio = 0.637 (95% CI 0.490, 0.830), P=0.007); one-year survival rates were 37% for patients who received Xospata compared to 17% for patients who received salvage chemotherapy.
Xospata was approved by the FDA in November 2018 for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation as detected by an FDA-approved test.
Xospata was discovered through a research collaboration with Kotobuki Pharmaceutical Co., and Astellas has exclusive global rights to develop, manufacture and commercialize Xospata.
Xospata was approved by the Japan Ministry of Health, Labor and Welfare for relapsed or refractory AML with FLT3 mutations and launched as Xospata 40 mg Tablets in 2018.
In February 2019, a marketing authorization application for the oral once-daily therapy Xospata for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation was accepted by the European Medicines Agency for regulatory review.
Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several phase III trials.
The phase III ADMIRAL trial (NCT02421939) was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3 mutations who are refractory to or have relapsed after first-line AML therapy.
The primary endpoint of the trial was overall survival. The study enrolled 371 patients with relapsed or refractory AML and positive for FLT3 mutations present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.
