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Safety and Tolerability of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFβ and PD-L1, in Asian Patients with Pretreated Recurrent or Refractory Gastric Cancer : Safety and Tolerability of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF beta and PD-L1, in Asian Patients with Pretreated Recurrent or Refractory Gastric Cancer
DC Field | Value | Language |
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dc.contributor.author | Kang, Yoon-Koo | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Kondo, Shunsuke | - |
dc.contributor.author | Chung, Hyun Cheol | - |
dc.contributor.author | Muro, Kei | - |
dc.contributor.author | Dussault, Isabelle | - |
dc.contributor.author | Helwig, Christoph | - |
dc.contributor.author | Osada, Motonobu | - |
dc.contributor.author | Doi, Toshihiko | - |
dc.date.accessioned | 2021-01-31T11:08:28Z | - |
dc.date.available | 2021-01-31T11:08:28Z | - |
dc.date.created | 2020-07-27 | - |
dc.date.created | 2020-07-27 | - |
dc.date.created | 2020-07-27 | - |
dc.date.issued | 2020-07 | - |
dc.identifier.citation | Clinical Cancer Research, Vol.26 No.13, pp.3202-3210 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.other | 108983 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173052 | - |
dc.description.abstract | Purpose: Patients with advanced gastric/gastroesophageal junction cancer (GC/GEJC) have limited treatment options after first-line therapy. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF beta RII receptor (a TGF beta "trap") fused to a human IgG1 antibody against programmed death ligand 1 (PD-L1), potentially offering a new treatment approach for these patients. We report results for bintrafusp alfa in GC/GEJC. Patients and Methods: Asian patients with recurrent GC/GEJC for whom standard therapy does not exist or for whom standard therapy has failed enrolled in this expansion cohort of an ongoing phase I trial and received bintrafusp alfa 1,200 mg once every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary objective was to assess safety/tolerability. Results: By July 23, 2018, 31 heavily pretreated patients received bintrafusp alfa for a median of 10.1 weeks; 3 patients remained on treatment. Six patients (19%) experienced grade 3 treatment-related adverse events (AE); no grade 4 events occurred. One on-treatment death occurred (sudden death); rupture of a preexisting thoracic aortic aneurysm was the suspected cause. Ten patients (32%) had immune-related AEs. The confirmed objective response rate per independent review committee was 16%; disease control rate was 26%. Median duration of response was 8.7 months (range, 2.4-12.4+). Responses occurred irrespective of PD-L1 expression or microsatellite instability status and appeared to correlate with high tumor TGFB1 levels. Conclusions: In this first evaluation in Asian patients with heavily pretreated advanced GC/GEJC, bintrafusp alfa demonstrated a manageable safety profile and clinical activity. | - |
dc.language | 영어 | - |
dc.publisher | American Association for Cancer Research | - |
dc.title | Safety and Tolerability of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFβ and PD-L1, in Asian Patients with Pretreated Recurrent or Refractory Gastric Cancer | - |
dc.title.alternative | Safety and Tolerability of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF beta and PD-L1, in Asian Patients with Pretreated Recurrent or Refractory Gastric Cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-19-3806 | - |
dc.citation.journaltitle | Clinical Cancer Research | - |
dc.identifier.wosid | 000546016400016 | - |
dc.identifier.scopusid | 2-s2.0-85087470344 | - |
dc.citation.endpage | 3210 | - |
dc.citation.number | 13 | - |
dc.citation.startpage | 3202 | - |
dc.citation.volume | 26 | - |
dc.identifier.sci | 000546016400016 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | GROWTH-FACTOR | - |
dc.subject.keywordPlus | READ ALIGNMENT | - |
dc.subject.keywordPlus | TGF-BETA-1 | - |
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