Open AccessOral histone deacetylase inhibitor tucidinostat ( HBI ‐8000) in patients with relapsed or refractory adult T‐cell leukemia/lymphoma: Phase IIb results
Author(s) -
Utsunomiya Atae,
Izutsu Koji,
Jo Tatsuro,
Yoshida Shinichiro,
Tsukasaki Kunihiro,
Ando Kiyoshi,
Choi Ilseung,
Imaizumi Yoshitaka,
Kato Koji,
Kurosawa Mitsutoshi,
Kusumoto Shigeru,
Miyagi Takashi,
Ohtsuka Eiichi,
Sasaki Osamu,
Shibayama Hirohiko,
Shimoda Kazuya,
Takamatsu Yasushi,
Takano Kuniko,
Yonekura Kentaro,
Makita Shinichi,
Taguchi Jun,
Gillings Mireille,
Onogi Hiroshi,
Tobinai Kensei
Publication year - 2022
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.15431
Subject(s) - medicine , gastroenterology , adverse effect , refractory (planetary science) , lymphoma , chemotherapy , phases of clinical research , leukemia , clinical endpoint , white blood cell , incidence (geometry) , mucositis , surgery , clinical trial , optics , physics , astrobiology
This multicenter, prospective phase IIb trial evaluating the efficacy and safety of tucidinostat (HBI‐8000) in patients with relapsed or refractory (R/R) adult T‐cell leukemia/lymphoma (ATLL) was undertaken in Japan. Eligible patients had R/R ATLL and had failed standard of care treatment with chemotherapy and with mogamulizumab. Twenty‐three patients received tucidinostat 40 mg orally twice per week and were included in efficacy and safety analyses. The primary end‐point was objective response rate (ORR) assessed by an independent committee. The ORR was 30.4% (95% confidence interval [CI], 13.2, 52.9]. Median progression‐free survival was 1.7 months (95% CI, 0.8, 7.4), median duration of response was 9.2 months (95% CI, 2.6, not reached), and median overall survival was 7.9 months (95% CI, 2.3, 18.0). All patients experienced adverse events (AEs), which were predominantly hematologic and gastrointestinal. Incidence of grade 3 or higher AEs was 78.3%; most were laboratory abnormalities (decreases in platelets, neutrophils, white blood cells, and hemoglobin). Tucidinostat was well tolerated with AEs that could be mostly managed with supportive care and dose modifications. Tucidinostat is a meaningful treatment option for R/R ATLL patients; further investigation is warranted.