Phase III ADMIRAL trial shows Xospata prolongs AML overall survival

Results of the Phase III ADMIRAL clinical trial comparing Xospata (gilteritinib) to salvage chemotherapy in adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation were presented at the American Association for Cancer Research (AACR) Annual Meeting, which suggest the drug is even better than it seemed when it secured accelerated US approval last November.

The results show that patients treated with Japanese pharma major Astellas Pharma’s (TYO: 4503) FLT3 (FMS-like tyrosine kinase 3) inhibitor Xospata had significantly longer overall survival (OS) than those who received standard salvage chemotherapy.

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=0.0007); one-year survival rates were 37% for patients who received Xospata compared to 17% for patients who received salvage chemotherapy.