Cited 50 times in
Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck: results from a phase I cohort
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2020-09-29T01:21:38Z | - |
dc.date.available | 2020-09-29T01:21:38Z | - |
dc.date.issued | 2020-07 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/179478 | - |
dc.description.abstract | Background: We report the clinical activity and safety of bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the transforming growth factor β (TGF-β)RII receptor (a TGF-β 'trap') fused to a human IgG1 monoclonal antibody blocking programmed death-ligand 1 (PD-L1), in patients with heavily pretreated squamous cell carcinoma of the head and neck (SCCHN). Methods: In this phase I dose-expansion cohort, patients with advanced SCCHN not amenable to curative therapy that progressed/recurred after platinum therapy in the recurrent/metastatic setting, or <6 months after platinum therapy in the locally advanced setting, received bintrafusp alfa 1200 mg intravenously every 2 weeks. The primary endpoint was confirmed best overall response (BOR; Response Evaluation Criteria for Solid Tumors (RECIST) 1.1) per independent review committee (IRC); other endpoints included BOR per investigator and safety. Results: As of August 24, 2018, 32 patients had received bintrafusp alfa (median follow-up 86.4 weeks; range 2-97). Per IRC, the confirmed objective response rate (ORR) was 13% (95% CI 4% to 29%; 4 partial responses (PR)); 4 patients had stable disease (SD) (disease control rate 25%; 95% CI 12% to 43%). Per investigator, there were 5 PRs (ORR, 16%), including 2 patients who developed delayed PRs after initial disease increase (total clinical response rate 22%). Responses (ORRs) were observed in patients with PD-L1-positive (12%), PD-L1-negative (17%; 73-10 antibody for immunohistochemistry), human papillomavirus (HPV)-positive (33%) and HPV-negative tumors (5%). Grade 3 treatment-related adverse events (TRAEs) were reported in 11 patients (34%), with no grade 4 TRAEs or treatment-related deaths. Conclusions: Bintrafusp alfa showed clinical activity across subgroups of PD-L1 expression and in HPV-positive tumors and had a manageable safety profile in patients with heavily pretreated advanced SCCHN. Activity in HPV-positive tumors is favorable compared with historical data from PD-L1 inhibitors and is being further investigated in an ongoing study of HPV-associated tumors. Trial registration number: NCT02517398 | - |
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 advanced squamous cell carcinoma of the head and neck: results from a phase I cohort | - |
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 | Amaury Daste | - |
dc.contributor.googleauthor | Alain Ravaud | - |
dc.contributor.googleauthor | Sébastien Salas | - |
dc.contributor.googleauthor | Nicolas Isambert | - |
dc.contributor.googleauthor | Edward McClay | - |
dc.contributor.googleauthor | Ahmad Awada | - |
dc.contributor.googleauthor | Christian Borel | - |
dc.contributor.googleauthor | Laureen S Ojalvo | - |
dc.contributor.googleauthor | Christoph Helwig | - |
dc.contributor.googleauthor | P Alexander Rolfe | - |
dc.contributor.googleauthor | James L Gulley | - |
dc.contributor.googleauthor | Nicolas Penel | - |
dc.identifier.doi | 10.1136/jitc-2020-000664 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J03617 | - |
dc.identifier.pmid | 32641320 | - |
dc.subject.keyword | clinical trials as topic | - |
dc.subject.keyword | head and neck neoplasms | - |
dc.subject.keyword | immunotherapy | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 8 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | e000664 | - |
dc.identifier.bibliographicCitation | JOURNAL FOR IMMUNOTHERAPY OF CANCER, Vol.8(2) : e000664, 2020-07 | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.