CONFERENCE UPDATE: EHA 2025

Gilteritinib continues to improve OS in R/R FLT3-mutated AML at 3-year follow-up of the Asian-centric phase 3 COMMODORE trial

HEMATOLOGY
19 Sep 2025

STUDY DESIGN 

Relapsed or refractory (R/R) FLT3-mutated acute myeloid leukemia (AML) is associated with a poor prognosis.1 While global trials have demonstrated that gilteritinib offers superior survival benefits and a favorable safety profile compared to standard chemotherapy, long-term randomized data in Asian populations remain limited.1 The COMMODORE study aimed to address this evidence gap by evaluating the long-term efficacy and safety of gilteritinib in a predominantly Asian cohort with R/R FLT3-mutated AML.1 In the primary analysis with a median follow-up of 10.3 months, gilteritinib significantly improved overall survival (OS) and event-free survival (EFS).1 This presentation described the long-term (3-year) follow-up results from the COMMODORE study in predominantly Asian patients.1

The COMMODORE study was a phase 3, randomized, open-label, multicenter trial conducted across 48 clinical sites in China, Malaysia, Thailand, Singapore, and Russia.1 Adults (≥18 years) with confirmed FLT3-mutated AML, either de novo or secondary to myelodysplastic syndrome, and an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 were randomized 1:1 to receive either oral gilteritinib (120mg/day) (n=137) or investigator-selected salvage chemotherapy (n=139).1 Patients with acute promyelocytic leukemia, blast-phase chronic myeloid leukemia, active central nervous system (CNS) disease, or chemotherapy-induced AML were excluded.1 Baseline characteristics were balanced between arms, and the majority of patients were Asian.1

The primary endpoint was OS.1 Secondary endpoints included event-free survival (EFS), complete remission (CR) rate, composite complete remission (CRc) rate, overall response rate (ORR), hematopoietic stem cell transplantation (HSCT) rate, transfusion conversion rate, and maintenance rate (for the gilteritinib arm only).1

 

FINDINGS

Primary endpoint:
  • The primary endpoint was OS1
  • At a median follow-up of 34.6 months, the gilteritinib arm had a median OS of 10.3 months compared with 5.4 months in the salvage chemotherapy arm, translating to a 39% reduction in the risk of death with gilteritinib (HR=0.61; 95% CI: 0.45-0.83; p=0.0015)1

Secondary endpoints:
  • Secondary endpoints included EFS, CR rate, CRc rate, ORR, HSCT rate, transfusion conversion rate, and maintenance rate for the gilteritinib arm1
  • EFS was significantly improved with gilteritinib: median EFS was 2.1 months vs. 0.6 months with salvage chemotherapy (HR=0.59; 95% CI: 0.44-0.79; p=0.00005)1
  • Response outcomes also favored gilteritinib over the chemotherapy arm: CR rate was 20.4% vs. 11.5%; CRc rate was 53.3% vs. 22.3%; and ORR was 67.9% vs. 27.3%, respectively1
  • A higher proportion of patients in the gilteritinib arm bridged to HSCT, with : 22.6% received HSCT at any point during the study, compared with 7.9% in the chemotherapy arm1
  • Transfusion independence was achieved in 46.5% of gilteritinib-treated patients, with a maintenance rate of 70.8%1

Safety:
  • The safety profile of gilteritinib remained consistent with previous reports, and no new safety concerns emerged over the extended follow-up period1

 

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