ICML 2025 | The real-world safety and efficacy of zanubrutinib in R/R MZL

We have presented in this International Conference Malignant Lymphoma our research focused on relapsed/refractory marginal zone lymphomas who have received at least one prior line of therapy including an anti-CD20 therapy, most of cases rituximab. So the same inclusion criteria of the Magnolia trial which was a phase two trial including 68 patients. We conducted a real-world, so out-of-clinical trials work in a multicentric way in Spain on behalf of the Spanish lymphoma group GELTAMO evaluating the efficacy and the safety of this therapy in marginal zone lymphomas. Our cohort was including patients with a median age of 76 years old at the moment of zanubrutinib onset most patients were females and the median number of prior lines was two. The distribution according to marginal zone lymphoma subtypes was half of patients having marginal zone lymphomas, 20% nodal marginal zone lymphomas and MALT another 20%. It’s important to say that our real-world cohort was composed of patients with cardiovascular risk factors. So most cases had at least one cardiovascular risk factor and 40% of patients had at least two cardiovascular risk factors. Important also that 20% of patients weren’t eligible for Magnolia inclusion. In our cohort we saw that the safety profile was quite good with 40% of adverse events, most of them low grade, 30% of the adverse events grade 3 or superior, and most common adverse events bleeding, cytopenias, infections and diarrhea, and no report of atrial fibrillation. It’s important that patients not eligible for Magnolia suffered more adverse events. The efficacy was good and equivalent to the clinical trial, to the Magnolia, with 70% of overall response rate with a complete remission rate of 20%. It’s important that regarding the number of prior lines received, the efficacy was not the same. So patients who were exposed only to one prior line of therapy presented better responses with an overall response rate of 85% and a complete response rate of 30%. Regarding other characteristics such as the marginal zone lymphoma subtype, the status of relapsed or refractory disease or even the Magnolia trial eligibility, we didn’t see differences about efficacy.

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