The Phase III PASHA trial of XOSPATA\u2122 reported no statistically significant difference in the primary endpoint of overall survival, with minimal impact expected on full-year financial 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Inc.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-03-09","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/03\/4503-20260309-01.pdf","jir_short_summary":"The Phase III PASHA trial of XOSPATA\u2122 reported no statistically significant difference in the primary endpoint of overall survival, with minimal impact expected on full-year financial results.","jir_summary":"### Summary of Phase III PASHA Trial Results\nAstellas Pharma announced the top-line results of the Phase III PASHA study evaluating XOSPATA\u2122 (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.\n\n### Outlook and Impact on Business Performance\nAstellas 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.","jir_financial_highlights":"Impact on Consolidated Full-Year Results (Fiscal Year Ending March 2026): Minimal (Unknown)","jir_category":"","jir_hashtags":"#AstellasPharma, #general_ir, #JapaneseStocks","jir_key_figures":"Phase III PASHA trial: No statistically significant difference in primary endpoint of overall survival\nComparable OS benefit between gilteritinib and midostaurin\nMinimal impact on consolidated full-year results (Fiscal Year Ending March 2026)","jir_meta_title":"Astellas Pharma Announces Phase III PASHA Trial Results for XOSPATA\u2122; Primary Endpoint Not Met but Minimal Impact on Earnings","jir_meta_description":"Astellas Pharma reported that the Phase III PASHA trial of XOSPATA\u2122 in untreated FLT3 mutation-positive AML patients did not meet the primary endpoint of overall survival with statistical significance, and expects minimal impact on full-year financial results.","jir_og_title":"Astellas Pharma Announces Phase III Trial Results of XOSPATA\u2122","jir_og_description":"Although the primary endpoint was not achieved in the Phase III PASHA trial of XOSPATA\u2122, the impact on earnings is reported to be minimal.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6911,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"general_ir","footnotes":""},"sector":[],"importance":[],"class_list":["post-33914","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n