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.

Details

Serval ID
serval:BIB_B5CFBB1D0A86
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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.
Journal
ESMO open
Author(s)
Girard N., Ponce Aix S., Cedres S., Berghmans T., Burgers S., Toffart A.C., Popat S., Janssens A., Gervais R., Hochstenbag M., Silva M., Burger I.A., Prosch H., Stahel R., Xenophontos E., Pretzenbaher Y., Neven A., Peters S.
ISSN
2059-7029 (Electronic)
ISSN-L
2059-7029
Publication state
Published
Issued date
06/2023
Peer-reviewed
Oui
Volume
8
Number
3
Pages
101576
Language
english
Notes
Publication types: Clinical Trial, Phase II ; Multicenter Study ; Journal Article
Publication Status: ppublish
Abstract
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.
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.
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.
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.
Keywords
Humans, Male, Female, Middle Aged, Nivolumab/adverse effects, Ipilimumab/adverse effects, Thymoma/drug therapy, Thymoma/chemically induced, Thymus Neoplasms/drug therapy, Thymus Neoplasms/chemically induced, Progression-Free Survival, immunotherapy, thymic carcinoma, thymoma
Pubmed
Web of science
Open Access
Yes
Create date
08/06/2023 13:43
Last modification date
09/12/2023 7:04
Usage data