Long-term follow-up of predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia in the phase 3 COMMODORE trial
Issued Date
2026-01-01
Resource Type
ISSN
09395555
eISSN
14320584
Scopus ID
2-s2.0-105027147248
Pubmed ID
41521262
Journal Title
Annals of Hematology
Volume
105
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Annals of Hematology Vol.105 No.1 (2026)
Suggested Citation
Jiang B., Li J., Liu L., Du X., Jiang H., Hu J., Zeng X., Sakatani T., Kosako M., Deng Y., Ivanov V., Bondarenko S., Lee Lee L.W., Khuhapinant A., Martynova E., Hasabou N., An J.J.H., Wang J. Long-term follow-up of predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia in the phase 3 COMMODORE trial. Annals of Hematology Vol.105 No.1 (2026). doi:10.1007/s00277-026-06762-2 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/114460
Title
Long-term follow-up of predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia in the phase 3 COMMODORE trial
Author's Affiliation
Fujian Medical University
Peking Union Medical College Hospital
Peking University People's Hospital
Siriraj Hospital
Guangdong Provincial People’s Hospital of Southern Medical University
Astellas Pharma Inc., Japan
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Almazov National Medical Research Centre
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Peking University International Hospital
Astellas Pharma US, Inc.
Ltd.
Queen Elizabeth Hospital
Pavlov University
Krasnoyarsk Regional Clinical Hospital
Peking Union Medical College Hospital
Peking University People's Hospital
Siriraj Hospital
Guangdong Provincial People’s Hospital of Southern Medical University
Astellas Pharma Inc., Japan
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Almazov National Medical Research Centre
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Peking University International Hospital
Astellas Pharma US, Inc.
Ltd.
Queen Elizabeth Hospital
Pavlov University
Krasnoyarsk Regional Clinical Hospital
Corresponding Author(s)
Other Contributor(s)
Abstract
To evaluate the long-term efficacy and safety of gilteritinib compared with salvage chemotherapy (SC) in patients with relapsed/refractory FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML). In the phase 3 COMMODORE (NCT03182244) trial, patients with relapsed/refractory FLT3-mutated AML from China, Russia, Singapore, Thailand, and Malaysia were randomized to gilteritinib (120 mg/day) or SC. The long-term follow-up included assessments every 3 months for a maximum of 3 years from the end-of-treatment visit. The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), complete remission (CR) rate, hematopoietic stem cell transplantation (HSCT) rate, and transfusion maintenance and conversion rates. Overall, 276 patients (gilteritinib, n = 137; SC, n = 139) completed the long-term follow-up. Most (88.0%) patients were Asian. The median (95% confidence interval [CI]) OS was longer with gilteritinib versus SC (10.3 [8.8, 12.7] vs 5.4 [4.1, 8.1] months, respectively; hazard ratio [HR; 95% CI], 0.612 [0.451, 0.832]), with a median follow-up of 34.6 months. The median (95% CI) EFS was longer with gilteritinib versus SC (2.1 [< 0.1, 3.2] vs 0.6 [0.2, 1.2] months, respectively; HR [95% CI], 0.589 [0.438, 0.792]). The CR rate was 20.4% and 11.5% in the gilteritinib and SC arms, respectively. During the entire study period, 22.6% and 7.9% of patients in the gilteritinib and SC arms underwent HSCT, respectively; 18.2% of patients in the gilteritinib arm received on-study HSCT. No new safety concerns were identified. Long-term gilteritinib treatment improved clinical outcomes compared with SC and was well-tolerated in a predominantly Asian population with relapsed/refractory FLT3-mutated AML.