Cited 6 times in
Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2024-01-03T01:16:23Z | - |
dc.date.available | 2024-01-03T01:16:23Z | - |
dc.date.issued | 2023-12 | - |
dc.identifier.issn | 1556-0864 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/197507 | - |
dc.description.abstract | Introduction: Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-βRII (a TGF-β "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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF THORACIC ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | B7-H1 Antigen / metabolism | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunologic Factors / therapeutic use | - |
dc.subject.MESH | Lung Neoplasms* | - |
dc.title | Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Jong Seok Lee | - |
dc.contributor.googleauthor | Yi-Long Wu | - |
dc.contributor.googleauthor | Irfan Cicin | - |
dc.contributor.googleauthor | Manuel Cobo Dols | - |
dc.contributor.googleauthor | Myung-Ju Ahn | - |
dc.contributor.googleauthor | Kristof Cuppens | - |
dc.contributor.googleauthor | Rémi Veillon | - |
dc.contributor.googleauthor | Ernest Nadal | - |
dc.contributor.googleauthor | Josiane Mourão Dias | - |
dc.contributor.googleauthor | Claudio Martin | - |
dc.contributor.googleauthor | Martin Reck | - |
dc.contributor.googleauthor | Edward B Garon | - |
dc.contributor.googleauthor | Enriqueta Felip | - |
dc.contributor.googleauthor | Luis Paz-Ares | - |
dc.contributor.googleauthor | Francoise Mornex | - |
dc.contributor.googleauthor | Everett E Vokes | - |
dc.contributor.googleauthor | Alex A Adjei | - |
dc.contributor.googleauthor | Clifford Robinson | - |
dc.contributor.googleauthor | Masashi Sato | - |
dc.contributor.googleauthor | Yulia Vugmeyster | - |
dc.contributor.googleauthor | Andreas Machl | - |
dc.contributor.googleauthor | Francois Audhuy | - |
dc.contributor.googleauthor | Surendra Chaudhary | - |
dc.contributor.googleauthor | Fabrice Barlesi | - |
dc.identifier.doi | 10.1016/j.jtho.2023.08.018 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J01909 | - |
dc.identifier.eissn | 1556-1380 | - |
dc.identifier.pmid | 37597750 | - |
dc.subject.keyword | Bintrafusp alfa | - |
dc.subject.keyword | NSCLC | - |
dc.subject.keyword | PD-L1 | - |
dc.subject.keyword | Phase 3 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 18 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 1731 | - |
dc.citation.endPage | 1742 | - |
dc.identifier.bibliographicCitation | JOURNAL OF THORACIC ONCOLOGY, Vol.18(12) : 1731-1742, 2023-12 | - |
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