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December 8, 2025BloodOpen Access

Efficacy and safety of rocbrutinib, a highly selective 4th-generation BTK inhibitor, in Chinese patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

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Authors

YSYuqin SongQCQingqing CaiKZKeshu Zhou

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Overview

Phase I trial demonstrates favorable safety profile and notable efficacy in CLL/SLL patients, suggesting potential benefits for prior BTK inhibitor users.

Key Points

  • Rocbrutinib led to a 91.7% overall response rate in first-line patients, indicating strong efficacy for CLL.
  • The trial reported significant adverse events including anemia and decreased neutrophil count, but no high-grade atrial fibrillation or hypertension.
  • Utilizing CTCAE v5.0 criteria, the study focused on treatment-related adverse events in relapsed/refractory CLL/SLL patients.
  • The findings suggest that rocbrutinib could provide a viable treatment option, particularly for those with TP53 mutations and past BTK inhibitor exposure.

Cite This Study

Song et al. (2025) studied this question.

synapsesocial.com/papers/69362f714fa91c937236e21dhttps://doi.org/10.1182/blood-2025-3896
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Efficacy and safety of rocbrutinib, a highly selective 4th-generation Bruton's tyrosine kinase inhibitor, in relapsed/refractory Mantle Cell Lymphoma (R/R MCL): Updated results from the phase 1 study2025
  2. 2Updates of R/R CLL with prior exposure to Bruton's tyrosine kinase (BTK) inhibitor and/or bcl-2 inhibitor in the Phase 1 trial of LP-168 (Rocbrutinib), a novel COVALENT and non-COVALENT BTK inhibitor2025 · 2 citations
  3. 3Efficacy and safety of rocbrutinib, the fourth generation bruton's tyrosine kinase inhibitor, in patients with BTK inhibitor pre-treated relapsed or refractory Mantle Cell Lymphoma: Results from a Phase II rock-1 trial2025 · 1 citations
  4. 4New BTK Inhibitors May Combat Resistance in CLL2025
  5. 5Docirbrutinib (AS-1763), a novel non-COVALENT pan-mutant BTK inhibitor, demonstrates durable clinical responses in patients with previously treated B-cell malignancies: Data from an ongoing Phase 1b study2025 · 1 citations