Titre :

Cusatuzumab for treatment of CD70-positive relapsed or refractory cutaneous T-cell lymphoma.

Auteur(s) :

Leupin, N. [Auteur]
Zinzani, P. L. [Auteur]
Alma Mater Studiorum Università di Bologna = University of Bologna [UNIBO]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Dalle, S. [Auteur]
Maerevoet, M. [Auteur]
Michot, J. M. [Auteur]
Ribrag, V. [Auteur]
Offner, F. [Auteur]
Beylot-Barry, M. [Auteur]
Moins-Teisserenc, H. [Auteur]
Zwaenepoel, K. [Auteur]
De Winne, K. [Auteur]
Battistella, M. [Auteur]
Hultberg, A. [Auteur]
Gandini, D. [Auteur]
Moshir, M. [Auteur]
Jacobs, J. [Auteur]
Delahaye, T. [Auteur]
Khan, A. [Auteur]
Zabrocki, P. [Auteur]
Silence, K. [Auteur]
Van Rompaey, L. [Auteur]
Borg, C. [Auteur]
Motta, G. [Auteur]
Melle, F. [Auteur]
Calleri, A. [Auteur]
Pauwels, P. [Auteur]
De Haard, H. [Auteur]
Pileri, S. [Auteur]
Bagot, M. [Auteur]
Immunologie humaine, physiopathologie & immunothérapie [HIPI (UMR_S_976 / U976)]

Titre de la revue :

Cancer

Nom court de la revue :

Cancer

Numéro :

128

Pagination :

1004-1014

Éditeur :

american cancer institut

Date de publication :

2021-11-03

ISSN :

1097-0142

Mot(s)-clé(s) en anglais :

translational
cusatuzumab
cutaneous T-cell lymphoma (CTCL)
clinical trial
CD70

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Background The clinical benefit of cusatuzumab, a CD70-directed monoclonal antibody with enhanced effector functions, was investigated in patients with relapsed/refractory (R/R) cutaneous T-cell lymphoma (CTCL). Methods In ...
Lire la suite >Background The clinical benefit of cusatuzumab, a CD70-directed monoclonal antibody with enhanced effector functions, was investigated in patients with relapsed/refractory (R/R) cutaneous T-cell lymphoma (CTCL). Methods In this cohort expansion of the ARGX-110-1201 study, 27 patients with R/R CTCL received cusatuzumab at 1 (n = 11) or 5 mg/kg (n = 16) once every 3 weeks to investigate its safety, dose, and exploratory efficacy. The pharmacokinetics, immunogenicity, CD70 expression, and CD70/CD27 biology were also assessed. Results The most common adverse events included infusion-related reactions, pyrexia, and asthenia. Eighteen serious adverse events (grade 1-3) were reported in 11 patients; 1 of these (vasculitis) was considered drug-related. For 8 of the 11 patients receiving 1 mg/kg, anti-drug antibodies (ADAs) affected the minimal concentration, and this resulted in undetectable cusatuzumab concentrations at the end of treatment and, in some cases, a loss of response. This effect was greatly reduced in the patients receiving 5 mg/kg. The overall response rate was 23%; this included 1 complete response and 5 partial responses (PRs) in 26 of the 27 evaluable patients. In addition, 9 patients achieved stable disease. The mean duration on cusatuzumab was 5.2 months, and the median duration was 2.5 months. Patients with Sézary syndrome (SS) achieved a 60% PR rate with a dosage of 5 mg/kg and a 33% PR rate with a dosage of 1 mg/kg; this resulted in an overall response rate of 50% for patients with SS at both doses. Conclusions Cusatuzumab was well tolerated, and antitumor activity was observed at both 1 and 5 mg/kg in highly pretreated patients with R/R CTCL. The observed dose-dependent effect on exposure supports the use of 5 mg/kg for future development.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Date de dépôt :

2023-05-25T02:55:45Z
2024-05-15T10:23:21Z