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<p>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; <i>p</i> &lt; 0.0001; crossing the efficacy boundary). The IRC-assessed overall response rate (90.1% vs 79.2%; <i>p</i> = 0.041) and duration of response (HR, 0.30; 95% CI, 0.15–0.60; <i>p</i> = 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.</p>

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Orelabrutinib versus chemoimmunotherapy in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月6日

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  • 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

摘要

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.