Until recently, no effective targeted therapies for FLT3-mutated (FLT3 relapsed/refractory (R/R) acute myeloid leukemia (AML) were available in Japan. The FLT3 inhibitor, gilteritinib, was approved in Japan for patients with FLT3 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).
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.
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%).
Findings in Japanese patients are consistent with those of the overall ADMIRAL study population.
© 2021. The Author(s).
About The Expert
Naoko Hosono
Hisayuki Yokoyama
Nobuyuki Aotsuka
Kiyoshi Ando
Hiroatsu Iida
Takayuki Ishikawa
Kensuke Usuki
Masahiro Onozawa
Masahiro Kizaki
Kohmei Kubo
Junya Kuroda
Yukio Kobayashi
Takayuki Shimizu
Shigeru Chiba
Miho Nara
Tomoko Hata
Michihiro Hidaka
Shin-Ichiro Fujiwara
Yoshinobu Maeda
Yasuyoshi Morita
Mikiko Kusano
Qiaoyang Lu
Shuichi Miyawaki
Erhan Berrak
Nahla Hasabou
Tomoki Naoe
References
PubMed