The results from the phase 3 ADMIRAL clinical trial comparing Gilteritinib ( Xospata ) to salvage chemotherapy in adult patients with relapsed or refractory acute myeloid leukemia ( AML ) with a FLT3 mutation, were presented at the American Association for Cancer Research ( AACR ) Annual Meeting.
Patients treated with Gilteritinib had significantly longer overall survival ( OS ) than those who received standard salvage chemotherapy.
Results from the ADMIRAL trial have shown the median overall survival for patients who received Gilteritinib was 9.3 months compared to 5.6 months for patients who received salvage chemotherapy ( hazard ratio, HR= 0.637 [ 95% CI 0.490, 0.830 ], P=0.0007 ); one-year survival rates were 37% for patients who received Gilteritinib compared to 17% for patients who received salvage chemotherapy.
The most common treatment-emergent adverse events ( TEAEs ) of any grade occurring in greater than or equal to 10% of patients during the first 30 days of treatment with Gilteritinib were anemia ( 33% ), increased alanine aminotransferase ( 24% ), increased aspartate aminotransferase ( 24% ), febrile neutropenia ( 21% ), thrombocytopenia ( 19% ), constipation ( 17% ), pyrexia ( 15% ), fatigue ( 15% ), decreased neutrophil count ( 14% ), increased blood alkaline phosphatase ( 13% ), nausea ( 13% ), hypokalemia ( 11% ), cough ( 11% ), headache ( 10% ), and diarrhea ( 10% ).
The most common TEAEs of any grade occurring in gretaer than or equal to 10% of patients during the first 30 days of treatment with salvage chemotherapy were anemia ( 33% ), febrile neutropenia ( 32% ), nausea ( 30% ), diarrhea ( 28% ), hypokalemia ( 27% ), pyrexia ( 26% ), decreased appetite ( 17% ), decreased white blood cell count ( 17% ), thrombocytopenia ( 16% ), constipation ( 14% ), abdominal pain ( 14% ), hyperglycemia ( 13% ), headache ( 13% ), stomatitis ( 13% ), fatigue ( 11% ), decreased neutrophil count ( 11% ), increased aspartate aminotransferase ( 10% ), vomiting ( 10% ), peripheral edema ( 10% ), and hypomagnesemia ( 10% ).
The ADMIRAL trial 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. ( Xagena )
Source: Astellas, 2019