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Efficacy of individualized orelabrutinib-based regimens in relapsed or refractory central nervous system lymphoma

Yuchen Wu1, Xuefei Sun1, Liwei Lv2

  • 1Department of Hematology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Frontiers in Neurology
|June 20, 2025
PubMed
Abstract

Insights

Orelabrutinib-based regimens (Ore-MIED/Ore-MTD) show high response rates in relapsed/refractory CNS lymphoma. This study suggests these treatments are effective and safe for patients with difficult-to-treat brain lymphomas.

Area of Science:

  • Neuro-oncology
  • Hematologic Malignancies
  • Pharmacology

Background:

  • Relapsed or refractory central nervous system lymphoma (rrCNSL) presents a significant clinical challenge with limited treatment options.
  • Bruton's tyrosine kinase inhibitors (BTKi) have emerged as a promising therapeutic class for B-cell malignancies.
  • Orelabrutinib, a second-generation BTKi, demonstrates high penetration into the cerebrospinal fluid, making it a potential candidate for CNS-targeted therapy.

Purpose of the Study:

  • To evaluate the efficacy and safety of orelabrutinib in combination with chemotherapy regimens in patients with rrCNSL.
  • To compare outcomes between two distinct orelabrutinib-based treatment strategies: Ore-MIED and Ore-MTD.

Main Methods:

  • A retrospective analysis was conducted on 37 patients diagnosed with relapsed or refractory central nervous system diffuse large B-cell lymphoma.
  • Patients received either orelabrutinib, high-dose methotrexate, ifosfamide, etoposide, and dexamethasone (Ore-MIED) or orelabrutinib, high-dose methotrexate, temozolomide and dexamethasone (Ore-MTD).

Main Results:

  • The overall response rate (ORR) for the combined cohort was 89.2%, with 51.4% achieving complete remission (CR) and 37.8% achieving partial remission (PR).
  • Median progression-free survival (PFS) was 7.0 months, with no statistically significant difference between the Ore-MTD (5.0 months) and Ore-MIED (13.0 months) groups (p=0.29).
  • Median overall survival (OS) has not yet been reached, suggesting durable responses and promising long-term outcomes.

Conclusions:

  • Orelabrutinib-based regimens (Ore-MIED/Ore-MTD) demonstrate significant effectiveness and a favorable safety profile in patients with rrCNSL.
  • These treatment strategies offer a viable therapeutic option for rrCNSL patients, including those with extensive prior treatment exposure.
  • The findings support the continued investigation of orelabrutinib in the management of CNS lymphomas.
Keywords:
Bruton’s tyrosine kinase inhibitorcentral nervous system lymphomamethotrexateorelabrutinibrelapsed or refractory

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