Mosunetuzumab plus polatuzumab vedotin in relapsed/refractory MCL after BTK inhibitor therapy: a phase 2 study.

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dc.creatorBudde, Lihua E
dc.creatorKamdar, Manali
dc.creatorAssouline, Sarit E
dc.creatorChavez, Julio C
dc.creatorGhosh, Nilanjan
dc.creatorOllila, Thomas A
dc.creatorHodson, Daniel J
dc.creatorModi, Dipenkumar
dc.creatorBastos-Oreiro, Mariana
dc.creatorNaik, Seema G
dc.creatorNakhoda, Shazia K
dc.creatorBatlevi, Connie Lee
dc.creatorWang, Jue
dc.creatorMakadia, Sneha
dc.creatorKwan, Antonia
dc.creatorPenuel, Elicia
dc.creatorJing, Jing
dc.creatorWu, Hao
dc.creatorEad, Wahib
dc.creatorPham, Song
dc.creatorTo, Iris
dc.creatorWei, Michael C
dc.creatorWang, Michael
dc.date2026-05-20T00:30:34Z
dc.date2026-04-21
dc.date.accessioned2026-08-02T20:21:18Z
dc.descriptionPatients with relapsed/refractory mantle cell lymphoma (MCL), especially those progressing after Bruton tyrosine kinase (BTK) inhibitor and/or chimeric antigen receptor (CAR) T-cell therapy and those with high-risk features, have poor outcomes. The bispecific antibody, mosunetuzumab, combined with the antibody-drug-conjugate (ADC), polatuzumab vedotin (Mosun-Pola), targets CD20 and CD79b via independent cell-killing mechanisms. In this multicenter phase 2 study, patients with MCL who had received ≥2 prior lines of therapy, including a BTK inhibitor, were enrolled. Patients received outpatient fixed-duration mosunetuzumab subcutaneously (17 cycles), with Cycle 1 step-up dosing to mitigate cytokine release syndrome, and polatuzumab vedotin (1.8 mg/kg intravenously) for 6 cycles. The primary endpoint was centrally assessed best objective response rate. Forty-two patients with a median of 3 prior therapies were enrolled; 26% had prior CAR T-cell therapy. A number of patients had MCL with high-risk features (Ki-67 ≥50%, 67%; blastoid/pleomorphic morphology, 38%; TP53 aberration, 48%). Objective response occurred in 88.1% of evaluable patients (95% CI, 74.4-96.0) and complete response in 78.6% (95% CI, 63.2-89.7). With a median follow-up of 15.9 months, median progression-free survival was 18.6 months (95% CI, 13.9-not estimable). Consistent efficacy was observed in high-risk subgroups. Cytokine release syndrome occurred in 42.9% of patients and was limited to Grade 1-2 events. Mosun-Pola achieved high complete remission rates while maintaining a manageable safety profile in patients with relapsed/refractory MCL exhibiting high-risk features. This is the first bispecific-ADC combination therapy study in MCL. (Funded by F. Hoffmann-La Roche Ltd; ClinicalTrials.gov, NCT03671018).
dc.formatPrint-Electronic
dc.formatapplication/pdf
dc.identifier0006-4971
dc.identifierhttps://www.repository.cam.ac.uk/handle/1810/403244
dc.identifierhttps://doi.org/10.17863/CAM.130276
dc.identifier1528-0020
dc.identifier.urihttps://repo.dare.co.zw/handle/123456789/85880
dc.languageeng
dc.publisherAmerican Society of Hematology
dc.publisherDepartment of Haematology
dc.publisherhttps://doi.org/10.1182/blood.2025032422
dc.rightsAttribution 4.0 International
dc.rightshttps://creativecommons.org/licenses/by/4.0/
dc.subject32 Biomedical and Clinical Sciences
dc.subject3201 Cardiovascular Medicine and Haematology
dc.subject3202 Clinical Sciences
dc.subject3211 Oncology and Carcinogenesis
dc.subjectBiotechnology
dc.subjectImmunotherapy
dc.subjectLymphatic Research
dc.subjectRare Diseases
dc.subjectCancer
dc.subjectImmunization
dc.subjectGenetics
dc.subjectLymphoma
dc.subjectClinical Research
dc.subjectClinical Trials and Supportive Activities
dc.subjectHematology
dc.subjectOrphan Drug
dc.subjectGene Therapy
dc.subject6.1 Pharmaceuticals
dc.subject6.2 Cellular and gene therapies
dc.titleMosunetuzumab plus polatuzumab vedotin in relapsed/refractory MCL after BTK inhibitor therapy: a phase 2 study.
dc.typeArticle

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