Authors
Fei Li, Keshu Zhou, Wei Xu, Guohui Cui, Shuhua Yi, Jie Jin, Zunmin Zhu, Aili He, Jianqing Mi, Zhongjun Xia, Xiaobing Huang, Xin Zhou, Wenzheng Yu, Jingming Guo, Qingshu Zeng, Shihua Huang, Yuerong Shuang, Hongling Peng, Lihua Qiu, Bing Xu, Yan Li, Yanli Yang, Fuling Zhou, Yafei Wang, Lihong Liu, Jinhai Ren, Ying Li, Wei Yang, Jian Gu, Guifang Ouyang, Luoming Hua, Jin Zhang, Qing Xiao, Shunqing Wang, Qingyuan Zhang, Jing Liu, Kaiyang Ding, Liansheng Zhang, Yun Zeng, Zhenyu Li, Qin Wen, Kaibo Gao, Haiping Yang, Yirong Jiang, Yijian Chen, Zengjun Li, Xinran Tang, Weige Wang, Renbin Zhao, Lugui Qiu, Jianyong Li
Published in
Signal transduction and targeted therapy. Volume 11. Issue 1. Jul 06, 2026. Epub Jul 06, 2026.
Abstract
Orelabrutinib is a potent, irreversible, and highly-selective BTK inhibitor that has been approved for the treatment of relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL). This randomized, phase 3 study (ClinicalTrials.gov identifier: NCT04578613) compared orelabrutinib with chemoimmunotherapy in patients with treatment-naïve CLL/SLL. From February 20, 2021, to July 8, 2024, 192 eligible patients were randomly assigned (1:1) to receive either orelabrutinib (91 patients) or chlorambucil plus rituximab (101 patients), comprising the intention-to-treat population. At a median follow-up of 21.4 months (data cutoff, May 17, 2024), the primary endpoint of progression-free survival (PFS) per independent review committee (IRC) was not reached (NR; 95% CI, not estimable [NE]-NE) with orelabrutinib versus 19.4 months (95% CI, 16.6-NE) with chlorambucil plus rituximab (hazard ratio [HR], 0.32; 95% CI, 0.18-0.58; p < 0.0001; crossing the efficacy boundary). The IRC-assessed overall response rate (90.1% vs 79.2%; p = 0.041) and duration of response (HR, 0.30; 95% CI, 0.15-0.60; p = 0.0003) also favored orelabrutinib over chlorambucil plus rituximab. In the safety population, treatment-related adverse events occurred in 82 of 91 patients (90.1%) receiving orelabrutinib and 89 of 98 patients (90.8%) receiving chlorambucil plus rituximab, with 32 (35.2%) and 59 (60.2%) at grade 3 or worse, respectively. Orelabrutinib maintained or improved patient-reported outcomes compared with chemoimmunotherapy. In summary, orelabrutinib significantly improved PFS and response versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL, with a manageable safety profile, supporting it as an effective alternative first-line option.
PMID:
42402625
Bibliographic data and abstract were imported from PubMed on 06 Jul 2026.
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