First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743.

Détails

Ressource 1Télécharger: S0923753.pdf (634.96 [Ko])
Etat: Public
Version: Final published version
Licence: CC BY-NC-ND 4.0
ID Serval
serval:BIB_78CBA16F62E5
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743.
Périodique
Annals of oncology
Auteur⸱e⸱s
Peters S., Scherpereel A., Cornelissen R., Oulkhouir Y., Greillier L., Kaplan M.A., Talbot T., Monnet I., Hiret S., Baas P., Nowak A.K., Fujimoto N., Tsao A.S., Mansfield A.S., Popat S., Zhang X., Hu N., Balli D., Spires T., Zalcman G.
ISSN
1569-8041 (Electronic)
ISSN-L
0923-7534
Statut éditorial
Publié
Date de publication
05/2022
Peer-reviewed
Oui
Volume
33
Numéro
5
Pages
488-499
Langue
anglais
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
In the phase III CheckMate 743 study (NCT02899299), first-line nivolumab plus ipilimumab significantly improved overall survival (OS) versus chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM). We report updated data with 3-year minimum follow-up.
Adults with previously untreated, histologically confirmed, unresectable MPM and Eastern Cooperative Oncology Group performance status of ≤1 were randomized 1 : 1 to nivolumab (3 mg/kg every 2 weeks) plus ipilimumab (1 mg/kg every 6 weeks) for up to 2 years, or six cycles of platinum plus pemetrexed chemotherapy. This report includes updated efficacy and safety outcomes, exploratory biomarker analyses including four-gene inflammatory expression signature score, and a post hoc efficacy analysis in patients who discontinued treatment due to treatment-related adverse events (TRAEs).
With a median follow-up of 43.1 months, nivolumab plus ipilimumab continued to prolong OS versus chemotherapy. Median OS was 18.1 versus 14.1 months [hazard ratio (95% confidence interval), 0.73 (0.61-0.87)], and 3-year OS rates were 23% versus 15%, respectively. Three-year progression-free survival rates were 14% versus 1%, and objective response rates were 40% versus 44%. At 3 years, 28% versus 0% of responders had an ongoing response. Improved survival benefit with nivolumab plus ipilimumab versus chemotherapy was observed across subgroups, including histology. A high score of the four-gene inflammatory signature appeared to correlate with improved survival benefit with nivolumab plus ipilimumab. No new safety signals were observed with nivolumab plus ipilimumab, despite patients being off therapy for 1 year. In patients who discontinued nivolumab plus ipilimumab due to TRAEs, median OS was 25.4 months, and 34% of responders maintained their responses for ≥3 years after discontinuation.
With 3 years' minimum follow-up, nivolumab plus ipilimumab continued to provide long-term survival benefit over chemotherapy and a manageable safety profile, supporting the regimen as standard-of-care treatment for unresectable MPM, regardless of histology.
Mots-clé
Adult, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Humans, Ipilimumab/adverse effects, Mesothelioma, Malignant, Nivolumab/therapeutic use, Progression-Free Survival, CTLA-4, PD-L1, dual immunotherapy, first-line, immune checkpoint inhibitors, overall survival
Pubmed
Web of science
Open Access
Oui
Création de la notice
12/02/2022 15:49
Dernière modification de la notice
16/04/2024 7:19
Données d'usage