Cusatuzumab for treatment of CD70-positive relapsed or refractory cutaneous T-cell lymphoma. - Université de Lille Accéder directement au contenu
Article Dans Une Revue Cancer Année : 2021

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

N. Leupin
  • Fonction : Auteur
S. Dalle
  • Fonction : Auteur
M. Maerevoet
  • Fonction : Auteur
J. M. Michot
  • Fonction : Auteur
V. Ribrag
  • Fonction : Auteur
F. Offner
  • Fonction : Auteur
M. Beylot-Barry
  • Fonction : Auteur
H. Moins-Teisserenc
  • Fonction : Auteur
K. Zwaenepoel
  • Fonction : Auteur
K. de Winne
  • Fonction : Auteur
M. Battistella
  • Fonction : Auteur
A. Hultberg
  • Fonction : Auteur
D. Gandini
  • Fonction : Auteur
M. Moshir
  • Fonction : Auteur
J. Jacobs
  • Fonction : Auteur
T. Delahaye
  • Fonction : Auteur
A. Khan
  • Fonction : Auteur
P. Zabrocki
  • Fonction : Auteur
K. Silence
  • Fonction : Auteur
L. van Rompaey
  • Fonction : Auteur
C. Borg
  • Fonction : Auteur
G. Motta
  • Fonction : Auteur
F. Melle
  • Fonction : Auteur
A. Calleri
  • Fonction : Auteur
P. Pauwels
  • Fonction : Auteur
H. de Haard
  • Fonction : Auteur
S. Pileri
  • Fonction : Auteur

Résumé

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.
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Dates et versions

hal-04576041 , version 1 (15-05-2024)

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Citer

N. Leupin, P. L. Zinzani, Franck Morschhauser, S. Dalle, M. Maerevoet, et al.. Cusatuzumab for treatment of CD70-positive relapsed or refractory cutaneous T-cell lymphoma.. Cancer, 2021, Cancer, 128 (5), pp.1004-1014. ⟨10.1002/cncr.34005⟩. ⟨hal-04576041⟩
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