Publications

Detailed Information

First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors

DC Field Value Language
dc.contributor.authorBang, Y. J.-
dc.contributor.authorGiaccone, G.-
dc.contributor.authorIm, S. A.-
dc.contributor.authorOh, D. Y.-
dc.contributor.authorBauer, T. M.-
dc.contributor.authorNordstrom, J. L.-
dc.contributor.authorLi, H.-
dc.contributor.authorChichili, G. R.-
dc.contributor.authorMoore, P. A.-
dc.contributor.authorHong, S.-
dc.contributor.authorStewart, S. J.-
dc.contributor.authorBaughman, J. E.-
dc.contributor.authorLechleider, R. J.-
dc.contributor.authorBurris, H. A.-
dc.date.accessioned2021-01-31T11:57:40Z-
dc.date.available2021-01-31T11:57:40Z-
dc.date.created2018-08-20-
dc.date.created2018-08-20-
dc.date.created2018-08-20-
dc.date.issued2017-04-
dc.identifier.citationAnnals of Oncology, Vol.28 No.4, pp.855-861-
dc.identifier.issn0923-7534-
dc.identifier.other44815-
dc.identifier.urihttps://hdl.handle.net/10371/173163-
dc.description.abstractBackground: Margetuximab is an anti-HER2 antibody that binds with elevated affinity to both the lower and higher affinity forms of CD16A, an Fc-receptor important for antibody dependent cell-mediated cytotoxicity (ADCC) against tumor cells. A Phase 1 study was initiated to evaluate the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of margetuximab in patients with HER2-overexpressing carcinomas. Patients and methods: Patients with HER2-positive breast or gastric cancer, or other carcinomas that overexpress HER2, for whom no standard therapy was available, were treated with margetuximab by intravenous infusion at doses of 0.1-6.0 mg/kg for 3 of every 4 weeks (Regimen A) or once every 3 weeks (10-18 mg/kg) (Regimen B). Results: Sixty-six patients received margetuximab (34 patients for Regimen A and 32 patients for Regimen B). The MTD was not reached for either regimen. Treatment was well-tolerated, with mostly Grade 1 and 2 toxicities consisting of constitutional symptoms such as pyrexia, nausea, anemia, diarrhea, and fatigue. Among 60 response-evaluable patients, confirmed partial responses and stable disease were observed in 7 (12%) and 30 (50%) patients, respectively; 26 (70%) of these patients had received prior HER2-targeted therapy. Tumor reductions were observed in over half (18/23, 78%) of response-evaluable patients with breast cancer including durable (>30 weeks) responders. Ex vivo analyses of patient peripheral blood mononuclear cell samples confirmed the ability of margetuximab to support enhanced ADCC compared with trastuzumab. Conclusions: Margetuximab was well-tolerated and has promising single-agent activity. Further development efforts of margetuximab as single agent and in combination with other therapeutic agents are ongoing.-
dc.language영어-
dc.publisherOxford University Press-
dc.titleFirst-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors-
dc.typeArticle-
dc.contributor.AlternativeAuthor임석아-
dc.identifier.doi10.1093/annonc/mdx002-
dc.citation.journaltitleAnnals of Oncology-
dc.identifier.wosid000397622100031-
dc.identifier.scopusid2-s2.0-85015678089-
dc.citation.endpage861-
dc.citation.number4-
dc.citation.startpage855-
dc.citation.volume28-
dc.identifier.sci000397622100031-
dc.description.isOpenAccessY-
dc.contributor.affiliatedAuthorBang, Y. J.-
dc.contributor.affiliatedAuthorIm, S. A.-
dc.contributor.affiliatedAuthorOh, D. Y.-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusMETASTATIC BREAST-CANCER-
dc.subject.keywordPlusRECEPTOR POLYMORPHISMS-
dc.subject.keywordPlusADJUVANT CHEMOTHERAPY-
dc.subject.keywordPlusTRASTUZUMAB-
dc.subject.keywordPlusPHARMACOKINETICS-
dc.subject.keywordPlusPLUS-
dc.subject.keywordPlusEFFICACY-
dc.subject.keywordAuthormargetuximab-
dc.subject.keywordAuthorHER2-
dc.subject.keywordAuthorsolid tumor-
dc.subject.keywordAuthorbreast cancer-
dc.subject.keywordAuthorgastric cancer-
Appears in Collections:
Files in This Item:
There are no files associated with this item.

Altmetrics

Item View & Download Count

  • mendeley

Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.

Share