Publication date: Feb 17, 2025
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 WaldenstrcF6m 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.
| Concepts | Keywords |
|---|---|
| Investigator | Bruton tyrosine kinase |
| Japanese | Japanese |
| Lymphocytic | Waldenström Macroglobulinemia |
| Platelet | Zanubrutinib |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | macroglobulinemia |
| disease | IDO | cell |
| disease | MESH | malignancies |
| disease | MESH | chronic lymphocytic leukemia |
| disease | MESH | COVID-19 |