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Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial Morschhauser, Franck Iacoboni García-Calvo, Gloria Carlo-Stella, Carmelo Offner, Fritz C. Sureda-Balari, Ana Hutchings, Martin Institut Català de la Salut [Hutchings M] Department of Hematology and Phase 1 Unit, Rigshospitalet, Copenhagen, Denmark. [Morschhauser F] Université de Lille, CHU Lille, ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France. [Iacoboni G] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Carlo-Stella C] Humanitas Clinical and Research Center—IRCCS and Humanitas University, Rozzano, Italy. [Offner FC] Ghent University, Ghent, Belgium. [Sureda A] Institut Català d’Oncologia-Hospitalet, Institut d’Investigació Biomèdica de Bellvitge, Universitat de Barcelona, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Cèl·lules B - Tumors - Tractament Immunoglobulines - Ús terapèutic Sang - Malalties DISEASES::Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, B-Cell Other subheadings::Other subheadings::/therapy CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Bispecific Other subheadings::Other subheadings::Other subheadings::/administration & dosage ENFERMEDADES::neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma de células B Otros calificadores::Otros calificadores::/terapia COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos biespecíficos Otros calificadores::Otros calificadores::Otros calificadores::/administración & dosificación Glofitamab; B-Cell Lymphoma; Relapsed Glofitamab; Linfoma de células B; Recaída Glofitamab; Limfoma de cèl·lules B; Recaiguda PURPOSE Glofitamab is a T-cell–engaging bispecific antibody possessing a novel 2:1 structure with bivalency for CD20 on B cells and monovalency for CD3 on T cells. This phase I study evaluated glofitamab in relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). Data for single-agent glofitamab, with obinutuzumab pretreatment (Gpt) to reduce toxicity, are presented. METHODS Seven days before the first dose of glofitamab (0.005-30 mg), all patients received 1,000 mg Gpt. Dose-escalation steps were determined using a Bayesian continuous reassessment method with overdose control. Primary end points were safety, pharmacokinetics, and the maximum tolerated dose of glofitamab. RESULTS Following initial single-patient cohorts, 171 patients were treated within conventional multipatient cohorts and received at least one dose of glofitamab. This trial included heavily pretreated patients with R/R B-NHL; most were refractory to prior therapy (155; 90.6%) and had received a median of three prior therapies. One hundred and twenty-seven patients (74.3%) had diffuse large B-cell lymphoma, transformed follicular lymphoma, or other aggressive histology, and the remainder had indolent lymphoma subtypes. Five (2.9%) patients withdrew from treatment because of adverse events. Cytokine release syndrome occurred in 86 of 171 (50.3%) patients (grade 3 or 4: 3.5%); two (1.2%) patients experienced grade 3, transient immune effector cell–associated neurotoxicity syndrome-like symptoms. The overall response rate was 53.8% (complete response [CR], 36.8%) among all doses and 65.7% (CR, 57.1%) in those dosed at the recommended phase II dose. Of 63 patients with CR, 53 (84.1%) have ongoing CR with a maximum of 27.4 months observation. CONCLUSION In patients with predominantly refractory, aggressive B-NHL, glofitamab showed favorable activity with frequent and durable CRs and a predictable and manageable safety profile. 2022-06-29T09:38:29Z 2022-06-29T09:38:29Z 2021-06-20 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Hutchings M, Morschhauser F, Iacoboni G, Carlo-Stella C, Offner FC, Sureda A, et al. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. J Clin Oncol. 2021 Jun 20;39(18):1959–70. 1879-0887 https://hdl.handle.net/11351/7761 10.1200/JCO.20.03175 33739857 000628819400029 eng Journal of Clinical Oncology;39(18) http://dx.doi.org/10.1200/JCO.20.03175 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf application/pdf American Society of Clinical Oncology Scientia