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Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with human papillomavirus-associated malignancies
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2021-09-29T00:34:53Z | - |
dc.date.available | 2021-09-29T00:34:53Z | - |
dc.date.issued | 2020-12 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/183928 | - |
dc.description.abstract | Background: Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of transforming growth factor (TGF)-βRII (a TGF-β 'trap') fused to a human IgG1 mAb blocking programmed cell death ligand 1. This is the largest analysis of patients with advanced, pretreated human papillomavirus (HPV)-associated malignancies treated with bintrafusp alfa. Methods: In these phase 1 (NCT02517398) and phase 2 trials (NCT03427411), 59 patients with advanced, pretreated, checkpoint inhibitor-naive HPV-associated cancers received bintrafusp alfa intravenously every 2 weeks until progressive disease, unacceptable toxicity, or withdrawal. Primary endpoint was best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1; other endpoints included safety. Results: As of April 17, 2019 (phase 1), and October 4, 2019 (phase 2), the confirmed objective response rate per RECIST V.1.1 in the checkpoint inhibitor-naive, full-analysis population was 30.5% (95% CI, 19.2% to 43.9%; five complete responses); eight patients had stable disease (disease control rate, 44.1% (95% CI, 31.2% to 57.6%)). In addition, three patients experienced a delayed partial response after initial disease progression, for a total clinical response rate of 35.6% (95% CI, 23.6% to 49.1%). An additional patient with vulvar cancer had an unconfirmed response. Forty-nine patients (83.1%) experienced treatment-related adverse events, which were grade 3/4 in 16 patients (27.1%). No treatment-related deaths occurred. Conclusion: Bintrafusp alfa showed clinical activity and manageable safety and is a promising treatment in HPV-associated cancers. These findings support further investigation of bintrafusp alfa in patients with advanced, pretreated HPV-associated cancers. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BioMed Central | - |
dc.relation.isPartOf | JOURNAL FOR IMMUNOTHERAPY OF CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with human papillomavirus-associated malignancies | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Julius Strauss | - |
dc.contributor.googleauthor | Margaret E Gatti-Mays | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Andrew Hill 3 | - |
dc.contributor.googleauthor | Sébastien Salas | - |
dc.contributor.googleauthor | Edward McClay | - |
dc.contributor.googleauthor | Jason M Redman | - |
dc.contributor.googleauthor | Houssein A Sater | - |
dc.contributor.googleauthor | Renee N Donahue | - |
dc.contributor.googleauthor | Caroline Jochems | - |
dc.contributor.googleauthor | Elizabeth Lamping | - |
dc.contributor.googleauthor | Andrea Burmeister | - |
dc.contributor.googleauthor | Jennifer L Marté | - |
dc.contributor.googleauthor | Lisa M Cordes | - |
dc.contributor.googleauthor | Marijo Bilusic | - |
dc.contributor.googleauthor | Fatima Karzai | - |
dc.contributor.googleauthor | Laureen S Ojalvo | - |
dc.contributor.googleauthor | Genevieve Jehl | - |
dc.contributor.googleauthor | P Alexander Rolfe | - |
dc.contributor.googleauthor | Christian S Hinrichs | - |
dc.contributor.googleauthor | Ravi A Madan | - |
dc.contributor.googleauthor | Jeffrey Schlom | - |
dc.contributor.googleauthor | James L Gulley | - |
dc.identifier.doi | 10.1136/jitc-2020-001395 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J03617 | - |
dc.identifier.pmid | 33323462 | - |
dc.subject.keyword | programmed cell death 1 receptor | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 8 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | e001395 | - |
dc.identifier.bibliographicCitation | JOURNAL FOR IMMUNOTHERAPY OF CANCER, Vol.8(2) : e001395, 2020-12 | - |
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