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Clinical Trial
. 2025 Mar;104(3):1563-1575.
doi: 10.1007/s00277-025-06235-y. Epub 2025 Mar 10.

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

Bin Jiang  1 , Jian Li  2 , Ligen Liu  3 , Xin Du  4 , Hao Jiang  5 , Jianda Hu  6   7 , Xiaoxi Zeng  8 , Taishi Sakatani  9 , Masanori Kosako  9 , Yaru Deng  8 , Larisa Girshova  10 , Sergey Bondarenko  11 , Lily Wong Lee Lee  12 , Archrob Khuhapinant  13 , Elena Martynova  14 , Nahla Hasabou  15 , Jianxiang Wang  16
Affiliations
Clinical Trial

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

Bin Jiang et al. Ann Hematol. 2025 Mar.

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.

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Conflict of interest statement

Declarations. Ethical approval: This trial was conducted in accordance with the study protocol, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines and Declaration of Helsinki, and applicable regulations/guidelines governing clinical study conduct and ethical principles. Consent to participate: Written and signed informed consent was obtained from all patients or their guardian or legal representative prior to screening. The study sponsor ensured that the use and disclosure of protected health information obtained during the trial complied with federal and/or regional legislation related to the privacy and protection of personal information. Competing interests: JW, BJ, JL, LL, XD, HJ, JD, LG, SB, LWLL and EM have nothing to disclose. TS reports Astellas stocks. AK reports consulting and honoraria fees from Roche, Johnson & Johnson, Novartis, American Taiwan Biopharm, AstraZeneca, Dr. Reddy, Bristol Myers Squibb, and Apexcella; support for attending meetings and/or travel from American Taiwan Biopharm. XZ, TS, MK, YD, and NH are all employees of Astellas.

Figures

Fig. 1
Fig. 1
Kaplan–Meier estimates of (A) overall survival and (B) event-free survival in the China cohort (N = 151). P-values were calculated from the unstratified 2-side log-rank test. P-values should be considered nominal. HRs were based on the Cox proportional hazards model. Assuming proportional hazards, an HR < 1 indicates a reduction in hazard rate in favor of the treatment arm. CI, confidence interval; HR, hazard ratio; NE, not estimable; SC, salvage chemotherapy
Fig. 2
Fig. 2
Kaplan–Meier estimates of (A) overall survival and (B) event-free survival in the South-East Asia cohort (N = 50). P-values were calculated from the unstratified 2-side log-rank test. P-values should be considered nominal. HRs were based on the Cox proportional hazards model. Assuming proportional hazards, an HR < 1 indicates a reduction in hazard rate in favor of the treatment arm. CI, confidence interval; HR, hazard ratio; NE, not estimable; SC, salvage chemotherapy
Fig. 3
Fig. 3
Kaplan–Meier estimates of (A) overall survival and (B) event-free survival in the Russia cohort (N = 33). P-values were calculated from the unstratified 2-side log-rank test. P-values should be considered nominal. HRs were based on the Cox proportional hazards model. Assuming proportional hazards, an HR < 1 indicates a reduction in hazard rate in favor of the treatment arm. CI, confidence interval; HR, hazard ratio; NE, not estimable; SC, salvage chemotherapy
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