Efficacy and safety of nivolumab for patients with pre-treated type B3 thymoma and thymic carcinoma: results from the EORTC-ETOP NIVOTHYM phase II trial - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue ESMO Open Année : 2023

Efficacy and safety of nivolumab for patients with pre-treated type B3 thymoma and thymic carcinoma: results from the EORTC-ETOP NIVOTHYM phase II trial

Santiago Ponce Aix
  • Fonction : Auteur
Susana M. Cedres
  • Fonction : Auteur
Thierry Berghmans
  • Fonction : Auteur
Sjaak A. Burgers
  • Fonction : Auteur
Sanjay Popat
Annelies Janssens
  • Fonction : Auteur
Radj Gervais
  • Fonction : Auteur
Monique M.H. Hochstenbag
  • Fonction : Auteur
Mario Silva
Irene Andrea Burger
Helmut Prosch
Rolf Arno Stahel
  • Fonction : Auteur
E. Xenophontos
  • Fonction : Auteur
Y. Pretzenbaher
  • Fonction : Auteur
Anouk Neven
  • Fonction : Auteur
Solange Peters
  • Fonction : Auteur

Résumé

Background: Thymic malignancies are rare intrathoracic tumors, which may be aggressive and difficult to treat. They represent a therapeutic challenge in the advanced/metastatic setting, with limited treatment options after the failure of first-line platinum-based chemotherapy. They are frequently associated with autoimmune disorders that also impact oncological management. Materials and methods: NIVOTHYM is an international, multicenter, phase II, two-cohort, single-arm trial evaluating the activity and safety of nivolumab [240 mg intravenously (i.v.) q2 weeks] alone or with ipilimumab (1 mg /kg i.v. q6 weeks) in patients with advanced/relapsed type B3 thymoma or thymic carcinoma, after exposure to platinum-based chemotherapy. The primary endpoint is progression-free survival rate at 6 months (PFSR-6) based on RECIST 1.1 as per independent radiological review. Results: From April 2018 to February 2020, 55 patients were enrolled in 15 centers from 5 countries. Ten patients (18%) had type B3 thymoma and 43 (78%) had thymic carcinoma. The majority were male (64%), and the median age was 58 years. Among the 49 eligible patients who started treatment, PFSR-6 by central review was 35% [95% confidence interval (CI) 22% to 50%]. The overall response rate and disease control rate were 12% (95% CI 5% to 25%) and 63% (95% CI 48% to 77%), respectively. Using the Kaplan–Meier method, median progression-free survival and overall survival by local assessment were 6.0 (95% CI 3.1-10.4) months and 21.3 (95% CI 11.6-not estimable) months, respectively. In the safety population of 54 patients, adverse events (AEs) of grade 1/2 were observed in 22 (41%) patients and grade 3/4 in 31 (57%) patients. Treatment-related AEs of grade 4 included one case of neutropenia, one case of immune-mediated transaminitis, and two cases of myocarditis. Conclusions: Nivolumab monotherapy demonstrated an acceptable safety profile and objective activity, although it has been insufficient to meet its primary objective. The second cohort of NIVOTHYM is currently ongoing to assess the combination of nivolumab plus ipilimumab.
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hal-04191650 , version 1 (26-09-2023)

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Nicolas Girard, Santiago Ponce Aix, Susana M. Cedres, Thierry Berghmans, Sjaak A. Burgers, et al.. Efficacy and safety of nivolumab for patients with pre-treated type B3 thymoma and thymic carcinoma: results from the EORTC-ETOP NIVOTHYM phase II trial. ESMO Open, 2023, 8 (3), ⟨10.1016/j.esmoop.2023.101576⟩. ⟨hal-04191650⟩
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