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http://hdl.handle.net/2445/181156
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 |
Author: | Hutchings, Martin Morschhauser, Franck Iacoboni, Gloria Carlo-Stella, Carmelo Offner, Fritz Sureda, Anna Salles, Gilles Martínez Lopez, Joaquín Crump, Michael Thomas, Denise N. Morcos, Peter N. Ferlini, Cristiano Bröske, Ann-Marie E. Belousov, Anton Bacac, Marina Dimier, Natalie Carlile, David J. Lundberg, Linda Perez Callejo, David Umaña, Pablo Moore, Tom Weisser, Martin Dickinson, Michael J. |
Keywords: | Malalties del sistema limfàtic Anticossos monoclonals Lymphatic diseases Monoclonal antibodies |
Issue Date: | 20-Jun-2021 |
Publisher: | American Society of Clinical Oncology |
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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1200/JCO.20.03175 |
It is part of: | Journal of Clinical Oncology, 2021, vol. 39, num. 18, p. 1959-1970 |
URI: | http://hdl.handle.net/2445/181156 |
Related resource: | https://doi.org/10.1200/JCO.20.03175 |
ISSN: | 0732-183X |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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