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December 8, 2025BloodOpen Access

Efficacy 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 trial

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Authors

ZPZhigang PengKDKaiyang DingJWJianqiu Wu

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Overview

Phase II trial shows rocbrutinib improves progression-free survival in relapsed mantle cell lymphoma with manageable adverse events.

Key Points

  • To assess the efficacy and safety of rocbrutinib in patients with relapsed or refractory mantle cell lymphoma.
  • Phase II single-arm trial conducted across 27 centers in China
  • Participants received oral rocbrutinib 150 mg daily until progression or unacceptable toxicity
  • Primary endpoint: overall response rate assessed by independent review
  • Secondary endpoints: duration of response, progression-free survival, overall survival, and safety
  • Overall response rate was 63.9%, including 23.0% complete response
  • Median progression-free survival was 7.39 months
  • Median duration of response was 16.46 months
  • Treatment emergent adverse events included thrombocytopenia in 43.5% and anemia in 30.6%

Cite This Study

Peng et al. (2025) studied this question.

synapsesocial.com/papers/69362f514fa91c937236d96fhttps://doi.org/10.1182/blood-2025-886
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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. 2Efficacy and safety of rocbrutinib, a highly selective 4th-generation BTK inhibitor, in Chinese patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)2025 · 3 citations
  3. 3Updates 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
  4. 4ROCK-2: An ongoing open-label, randomized, multicenter phase 2 study of rocbrutinib versus investigator's choice of therapy in patients with R/R non-GCB DLBCL.2026
  5. 5ROCKET-CLL: A randomized, open-label, multicenter, phase 3 study of rocbrutinib (LP-168) versus pirtobrutinib in covalent BTK inhibitor (cBTKi) in pretreated relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).2026