Phase 3 study of gilteritinib versus salvage chemotherapy in predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia
1
Issued Date
2024-01-01
Resource Type
ISSN
08876924
eISSN
14765551
Scopus ID
2-s2.0-85203130497
Journal Title
Leukemia
Rights Holder(s)
SCOPUS
Bibliographic Citation
Leukemia (2024)
Suggested Citation
Wang J., Jiang B., Li J., Liu L., Du X., Jiang H., Hu J., Yuan M., Sakatani T., Kadokura T., Takeuchi M., Kosako M., Ma X., Girshova L., Tan J., Bondarenko S., Lee L.W.L., Khuhapinant A., Martynova E., Hasabou N. Phase 3 study of gilteritinib versus salvage chemotherapy in predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia. Leukemia (2024). doi:10.1038/s41375-024-02382-9 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/101172
Title
Phase 3 study of gilteritinib versus salvage chemotherapy in predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia
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
Ltd.
Ampang Hospital
Krasnoyarsk Regional Clinical Hospital
Queen Elizabeth 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
Ltd.
Ampang Hospital
Krasnoyarsk Regional Clinical Hospital
Queen Elizabeth Hospital
Corresponding Author(s)
Other Contributor(s)
Abstract
The phase 3 COMMODORE trial evaluated gilteritinib versus salvage chemotherapy (SC) in a predominantly Asian relapsed/refractory (R/R) FLT3-mutated (FLT3mut+) acute myeloid leukemia (AML) patient population. The primary endpoint was overall survival (OS); secondary endpoints included event-free survival (EFS) and complete remission (CR) rate. As of June 30, 2020 (interim analysis: 32.2 months after study initiation), 234 patients were randomized (gilteritinib, n = 116; SC, n = 118). Median OS was significantly longer with gilteritinib versus SC (9.6 vs. 5.0 months; HR 0.566 [95% CI: 0.392, 0.818]; p = 0.00211) with a median follow-up of 10.3 months. Median EFS was also significantly longer with gilteritinib (2.8 vs. 0.6 months; HR 0.551 [95% CI: 0.395, 0.769]; p = 0.00004). CR rates with gilteritinib and SC were 16.4% and 10.2%, respectively; composite CR rates were 50.0% and 20.3%, respectively. Exposure-adjusted grade ≥3 adverse event (AE) rates were lower with gilteritinib (58.38 events/patient-year [E/PY]) versus SC (168.30 E/PY). Common AEs with gilteritinib were anemia (77.9%) and thrombocytopenia (45.1%). Gilteritinib plasma concentration peaked ~4 h postdose; ~3-fold accumulation occurred with multiple dosing. The COMMODORE trial demonstrated that gilteritinib significantly improved OS and EFS in predominantly Asian patients, validating the outcomes of gilteritinib from the ADMIRAL trial in R/R FLT3mut+ AML. (Figure presented.)