Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial.
J Thorac Oncol
; 18(12): 1731-1742, 2023 12.
Article
em En
| MEDLINE
| ID: mdl-37597750
ABSTRACT
INTRODUCTION:
Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-ßRII (a TGF-ß "trap") fused to a human immunoglobulin G1 monoclonal antibody blocking programmed death-ligand 1 (PD-L1), has exhibited clinical activity in a phase 1 expansion cohort of patients with PD-L1-high advanced NSCLC.METHODS:
This adaptive phase 3 trial (NCT03631706) compared the efficacy and safety of bintrafusp alfa versus pembrolizumab as first-line treatment in patients with PD-L1-high advanced NSCLC. Primary end points were progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1 per independent review committee and overall survival.RESULTS:
Patients (N = 304) were randomized one-to-one to receive either bintrafusp alfa or pembrolizumab (n = 152 each). The median follow-up was 14.3 months (95% confidence interval [CI] 13.1-16.0 mo) for bintrafusp alfa and 14.5 months (95% CI 13.1-15.9 mo) for pembrolizumab. Progression-free survival by independent review committee was not significantly different between bintrafusp alfa and pembrolizumab arms (median = 7.0 mo [95% CI 4.2 mo-not reached (NR)] versus 11.1 mo [95% CI 8.1 mo-NR]; hazard ratio = 1.232 [95% CI 0.885-1.714]). The median overall survival was 21.1 months (95% CI 21.1 mo-NR) for bintrafusp alfa and 22.1 months (95% CI 20.4 mo-NR) for pembrolizumab (hazard ratio = 1.201 [95% CI 0.796-1.811]). Treatment-related adverse events were higher with bintrafusp alfa versus pembrolizumab; grade 3-4 treatment-related adverse events occurred in 42.4% versus 13.2% of patients, respectively. The study was discontinued at an interim analysis as it was unlikely to meet the primary end point.CONCLUSIONS:
First-line treatment with bintrafusp alfa did not exhibit superior efficacy compared with pembrolizumab in patients with PD-L1-high, advanced NSCLC.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
6_ODS3_enfermedades_notrasmisibles
Problema de saúde:
6_other_respiratory_diseases
/
6_trachea_bronchus_lung_cancer
Assunto principal:
Carcinoma Pulmonar de Células não Pequenas
/
Neoplasias Pulmonares
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
J Thorac Oncol
Ano de publicação:
2023
Tipo de documento:
Article