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
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(<sup>mut+</sup>) 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 FLT3<sup>mut+</sup> AML, and affirming the clinical benefit of gilteritinib in three different patient populations. ClinicalTrials.gov identifier: NCT03182244.
Authors
- Ligen Liu (ORCID: https://orcid.org/0000-0002-3971-783X)
- Larisa Girshova (ORCID: https://orcid.org/0000-0002-0559-9556)
- Bin Jiang (ORCID: https://orcid.org/0000-0003-2473-2129)
- Nahla Hasabou
- Masanori Kosako (ORCID: https://orcid.org/0000-0002-4981-9450)
- Xiaoxi Zeng (ORCID: https://orcid.org/0000-0001-9946-4291)
- Elena Martynova (ORCID: https://orcid.org/0000-0003-0802-0236)
- Jianda Hu (ORCID: https://orcid.org/0000-0002-4438-2544)
- Taishi Sakatani (ORCID: https://orcid.org/0000-0001-9585-3855)
- Lily Wong Lee Lee
- Jianxiang Wang (ORCID: https://orcid.org/0000-0001-9437-9151)
- Sergey N. Bondarenko (ORCID: https://orcid.org/0000-0002-2446-8092)
- Jian Li (ORCID: https://orcid.org/0000-0002-4549-0694)
- Hao Jiang (ORCID: https://orcid.org/0000-0003-4123-4930)
- Xin Du (ORCID: https://orcid.org/0000-0003-2648-9433)
- Yaru Deng
- Archrob Khuhapinant
Institutions
- Fujian Medical University (CN)
- Siriraj Hospital (TH)
- Astellas Pharma (Japan) (JP)
- Shanghai Jiao Tong University (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Peking University (CN)
- Mahidol University (TH)
- First Pavlov State Medical University of St. Petersburg (RU)
- Peking Union Medical College Hospital (CN)
- Federal Almazov North-West Medical Research Centre (RU)
- Astellas Pharma (China) (CN)
- Tongren Hospital (CN)
- Krasnoyarsk Regional Clinical Hospital (RU)
- Peking University People's Hospital (CN)
- Peking University International Hospital (CN)
- Second Affiliated Hospital of Fujian Medical University (CN)
- Institute of Hematology & Blood Diseases Hospital (CN)
- Guangdong Provincial People's Hospital (CN)
- Union Hospital (CN)
- Queen Elizabeth Hospital (MY)
- Astellas Pharma (United States) (US)
Publication Details
- Journal
- Annals of Hematology
- Published
- 2025-03-01
- DOI
- https://doi.org/10.1007/s00277-025-06235-y
- Citations
- 1
- Primary Topic
- Acute Myeloid Leukemia Research
- Type
- article
- Field-Weighted Citation Impact
- 1.77
Funders
- Astellas Pharma