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http://hdl.handle.net/2445/181156
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DC Field | Value | Language |
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dc.contributor.author | Hutchings, Martin | - |
dc.contributor.author | Morschhauser, Franck | - |
dc.contributor.author | Iacoboni, Gloria | - |
dc.contributor.author | Carlo-Stella, Carmelo | - |
dc.contributor.author | Offner, Fritz | - |
dc.contributor.author | Sureda, Anna | - |
dc.contributor.author | Salles, Gilles | - |
dc.contributor.author | Martínez Lopez, Joaquín | - |
dc.contributor.author | Crump, Michael | - |
dc.contributor.author | Thomas, Denise N. | - |
dc.contributor.author | Morcos, Peter N. | - |
dc.contributor.author | Ferlini, Cristiano | - |
dc.contributor.author | Bröske, Ann-Marie E. | - |
dc.contributor.author | Belousov, Anton | - |
dc.contributor.author | Bacac, Marina | - |
dc.contributor.author | Dimier, Natalie | - |
dc.contributor.author | Carlile, David J. | - |
dc.contributor.author | Lundberg, Linda | - |
dc.contributor.author | Perez Callejo, David | - |
dc.contributor.author | Umaña, Pablo | - |
dc.contributor.author | Moore, Tom | - |
dc.contributor.author | Weisser, Martin | - |
dc.contributor.author | Dickinson, Michael J. | - |
dc.date.accessioned | 2021-11-10T11:29:28Z | - |
dc.date.available | 2021-12-20T06:10:24Z | - |
dc.date.issued | 2021-06-20 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | http://hdl.handle.net/2445/181156 | - |
dc.description.abstract | 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. | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1200/JCO.20.03175 | - |
dc.relation.ispartof | Journal of Clinical Oncology, 2021, vol. 39, num. 18, p. 1959-1970 | - |
dc.relation.uri | https://doi.org/10.1200/JCO.20.03175 | - |
dc.rights | (c) American Society of Clinical Oncology, 2021 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Malalties del sistema limfàtic | - |
dc.subject.classification | Anticossos monoclonals | - |
dc.subject.other | Lymphatic diseases | - |
dc.subject.other | Monoclonal antibodies | - |
dc.title | 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 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 713732 | - |
dc.date.updated | 2021-11-10T11:29:28Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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713732.pdf | 888.21 kB | Adobe PDF | View/Open |
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