What question did this study set out to answer?

The study aims to evaluate the effectiveness and safety of orelabrutinib combined with anti-CD20 monoclonal antibodies in treatment-naïve patients with marginal zone lymphoma.

April 15, 2026Open Access

Orelabrutinib with anti-CD20 monoclonal antibodies is highly effective and well-tolerated as first-line therapy for marginal zone lymphoma

Key Points

The study aims to evaluate the effectiveness and safety of orelabrutinib combined with anti-CD20 monoclonal antibodies in treatment-naïve patients with marginal zone lymphoma.
Retrospective analysis of 25 treatment-naïve patients with marginal zone lymphoma.
Patients received orelabrutinib plus either rituximab or obinutuzumab for 6 cycles.
Orelabrutinib maintenance was administered for up to 6 months.
Overall response rate was assessed based on the 2014 Lugano criteria.
Achieved an overall response rate of 96%, including 12 complete responses and 12 partial responses.
No significant difference in complete response rates between rituximab and obinutuzumab groups.
32% of patients experienced treatment-related adverse events, mostly neutropenia and thrombocytopenia.
Grade 3 to 4 adverse events occurred in 12% of patients.

Abstract

Marginal zone lymphoma (MZL) is an indolent subtype of non-Hodgkin lymphoma with heterogeneous clinical features. First-line treatment typically involves anti-CD20 monoclonal antibodies with or without chemotherapy. Although Bruton’s tyrosine kinase (BTK) inhibitors have demonstrated efficacy in relapsed/refractory (R/R) MZL, their role as first-line therapy remains unclear. This single-center retrospective study included 25 treatment-naïve patients with MZL who received orelabrutinib (150 mg once daily) plus either rituximab or obinutuzumab for 6 cycles, followed by orelabrutinib maintenance for up to 6 months. The primary endpoint was overall response rate (ORR), assessed according to the 2014 Lugano criteria. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. The ORR was 96.0%, comprising 12 complete response (CR) and 12 partial response (PR), with 1 case of stable disease (SD). Among the 13 patients with ocular adnexal MZL (OAML), 5 achieved CR, and 8 achieved PR. In the rituximab subgroup (n = 10), 5 patients achieved CR and 5 achieved PR, whereas in the obinutuzumab subgroup (n = 15), 7 achieved CR, 7 achieved PR, and 1 had SD; there was no significant difference in CR rate between the 2 groups (50.0% vs 46.7%, p = 1.000). Treatment-related adverse events (AEs) occurred in 32.0% of patients, with neutropenia (20.0%) and thrombocytopenia (12.0%) being the most common. Grade 3 to 4 events occurred in 12.0% of patients, with no significant differences in safety profiles between the rituximab and obinutuzumab subgroups. In conclusion, CD20 monoclonal antibodies combined with orelabrutinib may represent a feasible, low-toxicity first-line option for MZL, with favorable short-term efficacy and tolerability observed in this cohort. These preliminary findings warrant confirmation in larger prospective randomized studies to establish long-term benefits and safety.

Orelabrutinib with anti-CD20 monoclonal antibodies is highly effective and well-tolerated as first-line therapy for marginal zone lymphoma

Key Points

Abstract

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