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Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Patients With Non-Small Cell Lung Cancer Resistant or Refractory to Immune Checkpoint Inhibitors
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2023-07-12T02:25:12Z | - |
dc.date.available | 2023-07-12T02:25:12Z | - |
dc.date.issued | 2023-03 | - |
dc.identifier.issn | 1083-7159 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/195301 | - |
dc.description.abstract | BACKGROUND: Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of transforming growth factor beta receptor II (a TGF-β trap) fused to a human immunoglobulin G1 monoclonal antibody blocking programmed cell death 1 ligand 1 (PD-L1). We report the efficacy and safety in patients with non-small cell lung cancer (NSCLC) that progressed following anti-PD-(L)1 therapy. MATERIALS AND METHODS: In this expansion cohort of NCT02517398-a global, open-label, phase I trial-adults with advanced NSCLC that progressed following chemotherapy and was primary refractory or had acquired resistance to anti-PD-(L)1 treatment received intravenous bintrafusp alfa 1200 mg every 2 weeks until confirmed progression, unacceptable toxicity, or trial withdrawal. The primary endpoint was best overall response (by Response Evaluation Criteria in Solid Tumors version 1.1 adjudicated by independent review committee); secondary endpoints included safety. RESULTS: Eighty-three eligible patients (62 [74.7%] treated with ≥3 prior therapies) received bintrafusp alfa. Four patients (3 primary refractory, 1 acquired resistant) had confirmed partial responses (objective response rate, 4.8%; 95% CI, 1.3%-11.9%), and 9 had stable disease. Tumor cell PD-L1 expression was not associated with response. Nineteen patients (22.9%) experienced grade ≥3 treatment-related adverse events, most commonly asthenia (3 [3.6%]) and fatigue, eczema, and pruritus (2 each [2.4%]). One patient had grade 4 amylase increased. One patient died during treatment for pneumonia before initiation of bintrafusp alfa. CONCLUSION: Although the primary endpoint was not met, bintrafusp alfa showed some clinical activity and a manageable safety profile in patients with heavily pretreated NSCLC, including prior anti-PD-(L)1 therapy. Tumor responses occurred irrespective of whether disease was primary refractory or had acquired resistance to prior anti-PD-(L)1 therapy. © The Author(s) 2022. Published by Oxford University Press. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | AlphaMed Press | - |
dc.relation.isPartOf | ONCOLOGIST | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Antineoplastic Agents, Immunological* / therapeutic use | - |
dc.subject.MESH | B7-H1 Antigen | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / genetics | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immune Checkpoint Inhibitors / therapeutic use | - |
dc.subject.MESH | Immunologic Factors | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Lung Neoplasms* / genetics | - |
dc.subject.MESH | Transforming Growth Factor beta / genetics | - |
dc.subject.MESH | Transforming Growth Factor beta / therapeutic use | - |
dc.title | Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Patients With Non-Small Cell Lung Cancer Resistant or Refractory to Immune Checkpoint Inhibitors | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Fabrice Barlesi | - |
dc.contributor.googleauthor | Nicolas Isambert | - |
dc.contributor.googleauthor | Enriqueta Felip | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Dae Ho Lee | - |
dc.contributor.googleauthor | Julio Peguero | - |
dc.contributor.googleauthor | Guy Jerusalem | - |
dc.contributor.googleauthor | Nicolas Penel | - |
dc.contributor.googleauthor | Esma Saada-Bouzid | - |
dc.contributor.googleauthor | Pilar Garrido | - |
dc.contributor.googleauthor | Christoph Helwig | - |
dc.contributor.googleauthor | George Locke | - |
dc.contributor.googleauthor | Laureen S Ojalvo | - |
dc.contributor.googleauthor | James L Gulley | - |
dc.identifier.doi | 10.1093/oncolo/oyac253 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02415 | - |
dc.identifier.eissn | 1549-490X | - |
dc.identifier.pmid | 36571770 | - |
dc.subject.keyword | Bintrafusp alfa | - |
dc.subject.keyword | PD-L1 | - |
dc.subject.keyword | TGF-β | - |
dc.subject.keyword | bifunctional | - |
dc.subject.keyword | non-small cell lung cancer (NSCLC) | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 28 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 258 | - |
dc.citation.endPage | 267 | - |
dc.identifier.bibliographicCitation | ONCOLOGIST, Vol.28(3) : 258-267, 2023-03 | - |
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