Astellas Pharma Inc.
Top-line Results of Phase III PASHA Study of XOSPATA™ (Gilteritinib) in Untreated FLT3 Mutation-Positive AML Patients Eligible for Intensive Chemotherapy Announced
The Phase III PASHA trial of XOSPATA™ reported no statistically significant difference in the primary endpoint of overall survival, with minimal impact expected on full-year financial results.
Key Figures
- Phase III PASHA trial: No statistically significant difference in primary endpoint of overall survival
- Comparable OS benefit between gilteritinib and midostaurin
- Minimal impact on consolidated full-year results (Fiscal Year Ending March 2026)
AI要約
Summary of Phase III PASHA Trial Results
Astellas Pharma announced the top-line results of the Phase III PASHA study evaluating XOSPATA™ (gilteritinib) in untreated FLT3 mutation-positive acute myeloid leukemia (AML) patients. The primary endpoint of overall survival (OS) was not statistically significantly improved for the gilteritinib group compared to the midostaurin group, and the primary endpoint was not met. However, the OS benefit was similar between both groups, and the incidence of adverse events was comparable. Moving forward, a comprehensive data assessment including secondary endpoints and subgroup analyses is planned.
Outlook and Impact on Business Performance
Astellas Pharma will continue research and development targeting FLT3 mutations in AML. The impact on consolidated full-year results for the fiscal year ending March 2026 is expected to be minimal. The company remains committed to advancing AML treatment through international collaborations. Gilteritinib is currently marketed worldwide as a treatment for relapsed or refractory FLT3-mutated AML.
