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

Jiang B 1 , Li J 2 , Liu L 3 , Du X 4 , Jiang H 5 , Hu J 6 Show all authors , Zeng X 7 , Sakatani T 8 , Kosako M 8 , Deng Y 7 , Girshova L 9 , Bondarenko S 10 , Lee LWL 11 , Khuhapinant A 12 , Martynova E 13 , Hasabou N 14 , Wang J 15

Affiliations 

  • 1 Department of Hematology, Peking University International Hospital, Beijing, China
  • 2 Department of Hematology, Peking Union Medical College Hospital, Beijing, China
  • 3 Department of Hematology, Tongren Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 4 Department of Hematology, Guangdong Provincial People's Hospital, Guangzhou, China
  • 5 Department of Hematology, Peking University People's Hospital, Beijing, China
  • 6 Fujian Institute of Hematology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China
  • 7 Astellas China Investment Co, Ltd., Beijing, China
  • 8 Astellas Pharma, Inc., Tokyo, Japan
  • 9 Personalized Medicine Center, Almazov National Medical Research Center, St. Petersburg, Russia
  • 10 Department of Bone Marrow Transplantation of Adults, RM Gorbacheva Research Institute, Pavlov University, St. Petersburg, Russia
  • 11 Department of Hematology, Queen Elizabeth Hospital, Kota Kinabalu, Sabah, Malaysia
  • 12 Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • 13 Department of Hematology and Chemotherapy, Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk, Russia
  • 14 Astellas Pharma, Inc., Northbrook, IL, USA
  • 15 State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. wangjx@ihcams.ac.cn
Ann Hematol, 2025 Mar 10.
PMID: 40063243 DOI: 10.1007/s00277-025-06235-y

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. 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

Similar publications