Real-world effectiveness and safety of Zanubrutinib in Spanish patients with relapsed/refractory marginal zone lymphoma.

There is no established standard treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL). Zanubrutinib was approved in this setting based on the phase II MAGNOLIA trial. We retrospectively evaluated the characteristics and outcomes of 118 real-world patients in Spain with R/R MZL treated with zanubrutinib after at least one prior anti-CD20-based regimen. The median age at zanubrutinib initiation was 75 years, and 56% were female. MZL subtypes included splenic (55.3%), MALT (18.9%), nodal (19.8%), and non-classifiable (6%). The median number of prior lines of therapy (LoT) was 1.5 (range 1-7); 26% were refractory to the immediately preceding line, and 59% were POD24 to frontline. Thirty-one patients (26.3%) would not have met MAGNOLIA eligibility criteria, 68% had cardiovascular comorbidities, and 28% were receiving antithrombotic therapy. The overall and complete response rates were 76% and 22.2%, respectively, with no differences according to MZL subtype, age, POD24, or MAGNOLIA eligibility. Fewer prior LoT were associated with higher and deeper responses. With a median follow-up of 14 months, 1-year progression-free and overall survival were 79.4% and 86.8%, respectively. Zanubrutinib responders and patients with stable disease presented better outcomes than cases with progressing disease (p < 0.01). Adverse events (AEs) were reported in 34.1% of patients (grade ≥ 3 in 14.4%). MAGNOLIA-ineligible patients experienced a higher incidence of AEs, and bleeding events were more frequent among patients receiving anticoagulant therapy (p = 0.04). Overall, zanubrutinib demonstrated favorable effectiveness and safety in real-world R/R MZL, with improved outcomes when administered earlier in the disease.

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Journal
Blood Advances
Published
2026-08-25
DOI
https://doi.org/10.1182/bloodadvances.2026020480
Primary Topic
Chronic Lymphocytic Leukemia Research
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article
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article

Real-world effectiveness and safety of Zanubrutinib in Spanish patients with relapsed/refractory marginal zone lymphoma.

Esperanza Lavilla, Antonio Salar, Fernando Martín‐Moro, Alessandra Comai et al.
Blood Advances
Chronic Lymphocytic Leukemia Research
article

Real-world effectiveness and safety of Zanubrutinib in Spanish patients with relapsed/refractory marginal zone lymphoma.

Esperanza Lavilla, Antonio Salar, Fernando Martín‐Moro, Alessandra Comai, Paola Villafuerte‐Gutierrez, Eva Domingo‐Doménech, LUCIA MORAIS, Lucı́a Villalón, Ramón Díez-Feijoo, Mariana Bastos‐Oreiro, Xabier Gutiérrez López de Ocáriz, José-María Arguiñano, Rafael Lluch-García, Juan Gonzalo Correa, Sara Fernández‐Luis, Pablo Galindo-Navarro, Sergio Ramos-Cillán, Norma C. Gutiérrez, B. de la Cruz Benito, A. Soler, Jimena Cannata‐Ortiz, Carolina Villegas, Ana Muntañola, Javier López-Marín, Javier Marco, Ángeles Medina, Miriam Moreno, María Luisa Bengochea Casado, D. de Miguel Llorente, Cristina García-Herce, Sofia Martin-Consuegra, Itxaso Amarika, Nazaret Domínguez, María José Otero, Ana Jiménez-Ubieto, Maria Sofia Vazquez Diaz, Aranzazu Alonso, Marta Aceituno, Horacio Gulino, Armando López-Guillermo
article en

Abstract

There is no established standard treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL). Zanubrutinib was approved in this setting based on the phase II MAGNOLIA trial. We retrospectively evaluated the characteristics and outcomes of 118 real-world patients in Spain with R/R MZL treated with zanubrutinib after at least one prior anti-CD20-based regimen. The median age at zanubrutinib initiation was 75 years, and 56% were female. MZL subtypes included splenic (55.3%), MALT (18.9%), nodal (19.8%), and non-classifiable (6%). The median number of prior lines of therapy (LoT) was 1.5 (range 1-7); 26% were refractory to the immediately preceding line, and 59% were POD24 to frontline. Thirty-one patients (26.3%) would not have met MAGNOLIA eligibility criteria, 68% had cardiovascular comorbidities, and 28% were receiving antithrombotic therapy. The overall and complete response rates were 76% and 22.2%, respectively, with no differences according to MZL subtype, age, POD24, or MAGNOLIA eligibility. Fewer prior LoT were associated with higher and deeper responses. With a median follow-up of 14 months, 1-year progression-free and overall survival were 79.4% and 86.8%, respectively. Zanubrutinib responders and patients with stable disease presented better outcomes than cases with progressing disease (p < 0.01). Adverse events (AEs) were reported in 34.1% of patients (grade ≥ 3 in 14.4%). MAGNOLIA-ineligible patients experienced a higher incidence of AEs, and bleeding events were more frequent among patients receiving anticoagulant therapy (p = 0.04). Overall, zanubrutinib demonstrated favorable effectiveness and safety in real-world R/R MZL, with improved outcomes when administered earlier in the disease.

Blood Advances
Hebron University (PS), Universidad de Alcalá (ES), Instituto Cajal (ES), Hospital Universitario La Paz (ES), Hospital de Sant Pau (ES), Hospital General Universitario Gregorio Marañón (ES), Josep Carreras Leukaemia Research Institute (ES), Hospital Universitario Virgen Macarena (ES), Hospital General Nuestra Señora del Prado (ES), Hospital Universitario de Guadalajara (ES), Complejo Hospitalario de Navarra (ES), Marqués de Valdecilla University Hospital (ES), Hospital Universitario Fundación Alcorcón (ES), Hospital Universitario 12 De Octubre (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Institut Català d'Oncologia (ES), Hospital Universitario Araba (ES), Instituto de Investigación Marqués de Valdecilla (ES), Hospital Clínic de Barcelona (ES), Corporació Sanitària Parc Taulí (ES), Hospital Universitario Virgen de las Nieves (ES), Hospital de Galdakao (ES), Hospital Arnau de Vilanova (ES), National Cancer Registry (IE), Hospital de Manises (ES), Vall d'Hebron Hospital Universitari (ES), Hospital Juan Ramón Jiménez (ES), Hospital Universitario Fundación Jiménez Díaz (ES), Hospital Universitario de La Princesa (ES), Hospital Del Mar (ES), Hospital de Sant Joan Despí Moisès Broggi (ES), Hospital Universitario Central de Asturias (ES), Hospital General Universitario de Alicante Doctor Balmis (ES), Centro de Investigación del Cáncer (ES), Complexo Hospitalario Universitario A Coruña (ES), Hospital Universitario Lucus Augusti (ES), Hospital Universitario Virgen de la Arrixaca (ES), Hospital Ruber Internacional (ES), Hospital Comarcal de Inca (ES), Hospital Universitario Severo Ochoa (ES), Hospital Central de la Defensa Gómez Ulla (ES)
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