Gilteritinib versus chemotherapy in Japanese patients with FLT3-mutated relapsed/refractory acute myeloid leukemia

Author:

Hosono NaokoORCID,Yokoyama Hisayuki,Aotsuka Nobuyuki,Ando Kiyoshi,Iida Hiroatsu,Ishikawa Takayuki,Usuki Kensuke,Onozawa Masahiro,Kizaki Masahiro,Kubo Kohmei,Kuroda Junya,Kobayashi Yukio,Shimizu Takayuki,Chiba Shigeru,Nara Miho,Hata Tomoko,Hidaka Michihiro,Fujiwara Shin-Ichiro,Maeda Yoshinobu,Morita Yasuyoshi,Kusano Mikiko,Lu Qiaoyang,Miyawaki Shuichi,Berrak Erhan,Hasabou Nahla,Naoe Tomoki

Abstract

Abstract Background Until recently, no effective targeted therapies for FLT3-mutated (FLT3mut+) relapsed/refractory (R/R) acute myeloid leukemia (AML) were available in Japan. The FLT3 inhibitor, gilteritinib, was approved in Japan for patients with FLT3mut+ R/R AML based on the phase 3 ADMIRAL trial, which demonstrated the superiority of gilteritinib over salvage chemotherapy (SC) with respect to overall survival (OS; median OS, 9.3 vs 5.6 months, respectively; hazard ratio, 0.64 [95% confidence interval 0.49, 0.83]; P < 0.001). Methods We evaluated the Japanese subgroup (n = 48) of the ADMIRAL trial, which included 33 patients randomized to 120-mg/day gilteritinib and 15 randomized to SC. Results Median OS was 14.3 months in the gilteritinib arm and 9.6 months in the SC arm. The complete remission/complete remission with partial hematologic recovery rate was higher in the gilteritinib arm (48.5%) than in the SC arm (13.3%). After adjustment for drug exposure, fewer adverse events (AEs) occurred in the gilteritinib arm than in the SC arm. Common grade ≥ 3 AEs related to gilteritinib were febrile neutropenia (36%), decreased platelet count (27%), and anemia (24%). Conclusion Findings in Japanese patients are consistent with those of the overall ADMIRAL study population.

Funder

Astellas Pharma, Inc.

Publisher

Springer Science and Business Media LLC

Subject

Oncology,Hematology,General Medicine,Surgery

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