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
Issued Date
2025-01-01
Resource Type
ISSN
09395555
eISSN
14320584
Scopus ID
2-s2.0-86000766103
Journal Title
Annals of Hematology
Rights Holder(s)
SCOPUS
Bibliographic Citation
Annals of Hematology (2025)
Suggested Citation
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 L.W.L., 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. Annals of Hematology (2025). doi:10.1007/s00277-025-06235-y Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/106794
Title
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
Author's Affiliation
Siriraj Hospital
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Peking University People's Hospital
Peking University International Hospital
Astellas Pharma US, Inc.
Almazov National Medical Research Centre
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Guangdong Provincial People’s Hospital of Southern Medical University
Astellas Pharma Inc., Japan
Peking Union Medical College Hospital
Fujian Medical University
Pavlov University
Krasnoyarsk Regional Clinical Hospital
Queen Elizabeth Hospital
Ltd.
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Peking University People's Hospital
Peking University International Hospital
Astellas Pharma US, Inc.
Almazov National Medical Research Centre
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Guangdong Provincial People’s Hospital of Southern Medical University
Astellas Pharma Inc., Japan
Peking Union Medical College Hospital
Fujian Medical University
Pavlov University
Krasnoyarsk Regional Clinical Hospital
Queen Elizabeth Hospital
Ltd.
Corresponding Author(s)
Other Contributor(s)
Abstract
The COMMODORE study demonstrated the efficacy and safety of gilteritinib versus salvage chemotherapy (SC) treatment in a predominantly Asian population with relapsed/refractory (R/R) FMS-like tyrosine kinase 3 (FLT3)-mutated(mut+) acute myeloid leukemia (AML); here we present an exploratory analysis of the study stratified by region (China, South-East Asia and Russia). COMMODORE was a Phase 3, open-label, randomized (1:1), multicenter trial. There were 151, 50, and 33 patients in the China, South-East Asia, and Russia cohorts, respectively. Patients treated with gilteritinib had prolonged median overall survival (OS) versus SC-treated patients in all regions (China: 10.0 vs. 5.7 months, HR [95% CI]: 0.614 [0.385, 0.981]; South-East Asia: 7.8 vs. 4.7 months, HR [95% CI]: 0.887 [0.427, 1.843]; Russia: 8.8 vs. 2.6 months, HR [95% CI]: 0.271 [0.111, 0.662]). Improvements in event-free survival (EFS) were observed in the gilteritinib versus SC arms across all cohorts (China: 2.1 vs. 0.8 months; HR [95% CI]: 0.645 [0.427, 0.974]; South-East Asia 2.4 vs. < 0.1 months; HR [95% CI]: 0.415 [0.208, 0.830]; Russia: 6.2 vs. 0.6 months; HR [95% CI]: 0.221 [0.080, 0.614]). Complete remission rates were numerically higher in the gilteritinib versus SC arm across all three regions. Gilteritinib compared with SC treatment improved OS and EFS with no new safety signals, reinforcing the known efficacy and safety profile of gilteritinib in patients with R/R FLT3mut+ AML, and affirming the clinical benefit of gilteritinib in three different patient populations. ClinicalTrials.gov identifier: NCT03182244.