COMMODORE trial: Long-term follow up of gilteritinib vs salvage chemotherapy in R/R FLT3-mutated AML

Gilteritinib is an FLT3 inhibitor approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of adult patients with relapsed/refractory (R/R) FLT3-mutated (FLT3m) acute myeloid leukemia (AML). The primary analysis of the phase III COMMODORE trial (NCT03182244) demonstrated significant improvements in overall survival (OS) and event-free survival (EFS) rates with gilteritinib vs salvage chemotherapy in predominantly Asian patients with R/R FLT3m AML. However, long-term data on the efficacy and safety of gilteritinib treatment in Asian populations with FLT3m AML are limited.

During the European Hematology Association (EHA) 2025 Congress, June 12–15, 2025, Milan, IT, Jianxiang Wang presented long-term follow-up data from the COMMODORE trial in patients treated with gilteritinib (n = 137) vs salvage chemotherapy (n = 139). The primary endpoint was OS; key secondary endpoints were EFS and complete remission rate. The median follow-up was 34.6 months. 

Key learnings

Gilteritinib showed long-term OS and EFS benefit compared with salvage chemotherapy, with a 39% reduction in the risk of death (HR, 0.61; p = 0.0015) and a 41% reduction in the risk of an event (HR, 0.589; p = 0.00005), respectively.

CR (20.4% vs 11.5%) and CRc (53.3% vs 22.3%) rates were higher with gilteritinib than with salvage chemotherapy, respectively. The ORR was also higher with gilteritinib compared with salvage chemotherapy (67.9% vs 27.3%).

A higher proportion of patients underwent HSCT with gilteritinib than with salvage chemotherapy (22.6% vs 7.9%), with 80.6% of patients treated with gilteritinib receiving on-study HSCT.

Gilteritinib was well tolerated and continued to demonstrate clinical benefit vs salvage chemotherapy for up to 3 years in patients with R/R FLT3m AML. The findings validate the long-term efficacy and safety of gilteritinib.