A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

Summary

The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study evaluated safety as well as determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

Timeline

Start

2017-10-25

Primary completion

2023-12-25

Completion

2026-07-29

Outcome

Met primary endpoint

registry analysis (superiority test); Gilteritinib vs Salvage Chemotherapy; p = 0.00152; Hazard Ratio (HR) 0.612 (95% CI 0.451 to 0.832); Log Rank NCT03182244 ↗

Publications

• Perl AE, Levis MJ, Wei AH, Kim HJ, Cheong JW, Li J, Bondarenko S, Yokoyama H, Hosono N, Hasabou N, Elsouda D, Ariza J, An JJ, Wang J. Timing of response in patients with relapsed/refractory FLT3 mut+ acute myeloid leukemia treated with gilteritinib. Blood Neoplasia. 2026 Jul 13;3(4):100270. doi: 10.1016/j.bneo.2026.100270. eCollection 2026 Nov.
• Jiang B, Li J, Liu L, Du X, Jiang H, Hu J, Zeng X, Sakatani T, Kosako M, Deng Y, Girshova L, Bondarenko S, Lee LWL, Khuhapinant A, Martynova E, Hasabou N, Wang J. Gilteritinib versus salvage chemotherapy in predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia: a regional analysis of COMMODORE in China, South-East Asia, and Russia. Ann Hematol. 2025 Mar;104(3):1563-1575. doi: 10.1007/s00277-025-06235-y. Epub 2025 Mar 10.

Drugs

Indications