Phase 1b/2 study of blinatumomab in Japanese adults with relapsed/refractory acute lymphoblastic leukemia

Hitoshi Kiyoi, Joan D. Morris, Iekuni Oh, Yoshinobu Maeda, Hironobu Minami, Toshihiro Miyamoto, Toru Sakura, Hiroatsu Iida, Catherine A. Tuglus, Yuqi Chen, Cedric Dos Santos, James Kalabus, Abraham Anderson, Tomoko Hata, Yasuhiro Nakashima, Yukio Kobayashi

研究成果: ジャーナルへの寄稿学術誌査読

11 被引用数 (Scopus)

抄録

Adult patients with relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) have a poor prognosis. Blinatumomab is a bispecific T-cell engager (BiTE) immuno-oncology therapy with dual specificity for CD19 and CD3 that redirects patients’ CD3-positive cytotoxic T cells to lyse malignant and normal B cells. We conducted an open-label, phase 1b/2 study to determine the safety, pharmacokinetics, efficacy and recommended dose of blinatumomab in Japanese adults with R/R B-precursor ALL. Patients received 9 μg/day blinatumomab during week 1 and 28 μg/day during weeks 2-4, with a 2-week treatment-free interval (6-week cycle); patients received 28 μg/day blinatumomab in subsequent cycles. Primary endpoints were the incidence of dose-limiting toxicities (DLT) in phase 1b and complete remission (CR)/CR with partial hematologic recovery (CRh) within the first two cycles in phase 2. A total of 26 patients enrolled and 25 (96%) reported grade ≥3 adverse events (mostly cytopenias). There were no DLT. CR/CRh within two cycles was achieved by 4 of 5 patients (80%) in phase 1b and 8 of 21 patients (38%) in phase 2. Among patients with evaluable minimal residual disease, 4 (100%) in phase 1b and 3 (38%) in phase 2 had a complete MRD response. Median RFS for 8 patients who achieved CR/CRh in phase 2 was 5 (95% CI: 3.5-6.4) months; median OS was not estimable. There were no significant associations between maximum cytokine levels or percentage of specific cell types during cycle 1 and response. Consistent with global studies, blinatumomab appeared to be safe and efficacious in Japanese adults with R/R ALL.

本文言語英語
ページ(範囲)1314-1323
ページ数10
ジャーナルCancer Science
111
4
DOI
出版ステータス出版済み - 4月 1 2020

!!!All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 癌研究

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