Titre :

Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naïve Non-Small Cell Lung Cancer.

Auteur(s) :

Herbst, Roy S. [Auteur]
Yale School of Medicine [New Haven, Connecticut] [YSM]
Arkenau, Hendrik Tobias [Auteur]
University College of London [London] [UCL]
Bendell, Johanna [Auteur]
Sarah Cannon Research Institute [Nashville, Tennessee]
Arrowsmith, Edward [Auteur]
Sarah Cannon Research Institute [Nashville, Tennessee]
Wermke, Martin [Auteur]
Soriano, Andres [Auteur]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Santana-Davila, Rafael [Auteur]
University of Washington [Seattle]
Bischoff, Helge [Auteur]
Chau, Ian [Auteur]
Mi, Gu [Auteur]
Eli Lilly and Company [Indianapolis]
Wang, Hong [Auteur]
Eli Lilly and Company [Indianapolis]
Rasmussen, Erik [Auteur]
Ferry, David [Auteur]
Chao, Bo H. [Auteur]
Paz-Ares, Luis [Auteur]
Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] [UCM]

Titre de la revue :

Journal of Thoracic Oncology

Nom court de la revue :

J Thorac Oncol

Numéro :

16

Pagination :

289–98

Date de publication :

2020-10-24

ISSN :

1556-1380

Mot(s)-clé(s) en anglais :

Non-small cell lung cancer
Treatment-naive
Ramucirumab
Pembrolizumab

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Introduction Data of first-line ramucirumab plus pembrolizumab treatment of programmed death-ligand 1 (PD-L1)–positive NSCLC (cohort E) are reported (NCT02443324). Methods In this multicenter, open-label phase 1a/b ...
Lire la suite >Introduction Data of first-line ramucirumab plus pembrolizumab treatment of programmed death-ligand 1 (PD-L1)–positive NSCLC (cohort E) are reported (NCT02443324). Methods In this multicenter, open-label phase 1a/b trial, patients received ramucirumab 10 mg/kg and pembrolizumab 200 mg every 21 days for up to 35 cycles. PD-L1 positivity was defined as tumor proportion score (TPS) greater than or equal to 1%. Exploratory NanoString biomarker analyses included three T-cell signatures (T-cell–inflamed, Gajewski, and effector T cells) and CD274 gene expression. Results Cohort E included 26 patients. Treatment-related adverse events of any grade occurred in 22 patients (84.6%). Treatment-related adverse events of grade greater than or equal to 3 were reported in 11 patients (42.3%); the most frequent was hypertension (n = 4, 15.4%). Objective response rate was 42.3% in the treated population and 56.3% and 22.2% for patients with high (TPS ≥ 50%) and lower levels (TPS 1%–49%) of PD-L1 expression, respectively. Median progression-free survival (PFS) in the treated population was 9.3 months, and 12-month and 18-month PFS rates were 45% each. Median PFS was not reached in patients with PD-L1 TPS greater than or equal to 50% and was 4.2 months in patients with PD-L1 TPS 1% to 49%. Median overall survival was not reached in the treated population, and 12-month and 18-month overall survival rates were 73% and 64%, respectively. Biomarker data suggested a positive association among clinical response, three T-cell signatures, CD274 gene expression, and PD-L1 immunohistochemistry. Conclusions First-line therapy with ramucirumab plus pembrolizumab has a manageable safety profile in patients with NSCLC, and the efficacy signal seems to be strongest in tumors with high PD-L1 expression.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Date de dépôt :

2023-11-15T07:58:02Z
2023-12-13T12:51:03Z