#XOSPATA #gilteritinib #FLT3m+ AML

Astellas Presents Key Data on XOSPATA in AML at ASH 2025

Astellas Pharma Inc. has announced that it will present significant new findings regarding its drug, XOSPATA™ (gilteritinib), during the upcoming American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, scheduled from December 6 to December 9, 2025. The research highlights the effectiveness of XOSPATA across different clinical scenarios affecting patients with FMS-like tyrosine kinase 3 mutation-positive (FLT3m+) acute myeloid leukemia (AML), particularly those who are relapsed or refractory, newly diagnosed, or in need of post-transplant maintenance.

Research Highlights

The presentations at ASH 2025 will include a comprehensive post-hoc analysis combining data from two pivotal Phase 3 trials, ADMIRAL and COMMODORE. This analysis aims to assess the outcomes of patients who resumed gilteritinib treatment after hematopoietic stem cell transplantation (HSCT). By evaluating sequential therapies, the researchers hope to determine how they influence patient recovery and relapse rates.

Additionally, Astellas will share findings from the Phase 3 MORPHO trial. In collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), they will examine the impact of timing during the treatment pathway—from diagnosis to transplant—alongside the utilization of FLT3 inhibitors prior to transplant. This study aims to unravel how these factors can enhance patient outcomes in FLT3m+ AML.

Furthermore, the ongoing Phase 1/2 VICEROY study focuses on patients newly diagnosed with FLT3m+ AML who cannot undergo intensive chemotherapy. This study investigates a triplet combination therapy that includes gilteritinib, emphasizing both safety and effective dosing strategies.

Expert Insights

Dr. Moitreyee Chatterjee-Kishore, Head of Oncology Development at Astellas, expressed the company’s commitment to addressing the urgent needs of AML patients through continued research.