Zanubrutinib in Japanese treatment-naive and relapsed/refractory patients with Waldenström macroglobulinemia and CLL/SLL.

• Tác giả: Aileen Cohen, Katsuya Fujimoto, Tomoaki Fujisaki, Takayuki Ishikawa, Koji Izutsu, Tatsuro Jo, Senji Kasahara, Takeshi Kondo, Kohmei Kubo, Shingo Kurahashi, Koji Nagafuji, Tomonori Nakazato, Rika Sakai, Kazuyuki Shimada, Kazutaka Sunami, Motohisa Takai, Masahiro Takeuchi, Jinhua Zhong
• Ngôn ngữ: eng
• Thông tin xuất bản: Japan : International journal of hematology , 2025
• Bộ sưu tập: NCBI
• ID: 722179

Tóm tắt

 Zanubrutinib is a selective second-generation Bruton tyrosine kinase inhibitor approved in various B-cell malignancies globally. The phase 1/2 BGB-3111-111 study evaluated the efficacy and safety of zanubrutinib 160 mg twice daily orally in Japanese patients with treatment-naive or relapsed/refractory mature B-cell malignancies. Here, efficacy results from Part 2 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL
  n = 19) and Waldenström macroglobulinemia (WM
  n = 19), and safety results from Parts 1 (N = 6) and 2 (N = 49) are presented, with the first dose between 30 January, 2020, and 31 October, 2022. As of 10 May, 2023, investigator-assessed overall response rates were 100% (19/19) and 94.7% (18/19) in CLL/SLL and WM, respectively, with median follow-up of 27.9 and 26.8 months
  24-month progression-free survival rates were 71.4% and 100% in treatment-naive and relapsed/refractory CLL/SLL and 83.9% and 100% in treatment-naive and relapsed/refractory WM, respectively. In patients with B-cell malignancies, any-grade treatment-emergent adverse events (TEAEs) occurred in 53 (96.4%) and serious TEAEs in 18 (32.7%). Common TEAEs were platelet count decreased (18.2%), pyrexia (18.2%), COVID-19 (14.5%), and neutrophil count decreased (12.7%). With median follow-up >
  2 years, zanubrutinib demonstrated durable efficacy in Japanese patients with CLL/SLL or WM and a favorable safety profile consistent with global phase 3 studies.