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Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma

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dc.contributor.author라선영-
dc.date.accessioned2020-12-01T17:54:51Z-
dc.date.available2020-12-01T17:54:51Z-
dc.date.issued2020-07-
dc.identifier.issn0732-183X-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/180508-
dc.description.abstractPurpose: To evaluate the safety, pharmacokinetics, and preliminary activity of bemarituzumab in patients with FGFR2b-overexpressing gastric and gastroesophageal junction adenocarcinoma (GEA). Patients and methods: FPA144-001 was a phase I, open-label, multicenter trial consisting of the following 3 parts: part 1a involved dose escalation in patients with recurrent solid tumors at doses ranging from 0.3 to 15 mg/kg; part 1b involved dose escalation in patients with advanced-stage GEA; and part 2 involved dose expansion in patients with advanced-stage GEA that overexpressed FGFR2b at various levels (4 cohorts; high, medium, low, and no FGFR2b overexpression) and 1 cohort of patients with FGFR2b-overexpressing advanced-stage bladder cancer. Results: Seventy-nine patients were enrolled; 19 were enrolled in part 1a, 8 in part 1b, and 52 in part 2. No dose-limiting toxicities were reported, and the recommended dose was identified as 15 mg/kg every 2 weeks based on safety, tolerability, pharmacokinetic parameters, and clinical activity. The most frequent treatment-related adverse events (TRAEs) were fatigue (17.7%), nausea (11.4%), and dry eye (10.1%). Grade 3 TRAEs included nausea (2 patients) and anemia, neutropenia, increased AST, increased alkaline phosphatase, vomiting, and an infusion reaction (1 patient each). Three (10.7%) of 28 patients assigned to a cohort receiving a dose of ≥ 10 mg/kg every 2 weeks for ≥ 70 days reported reversible grade 2 corneal TRAEs. No TRAEs of grade ≥ 4 were reported. Five (17.9%; 95% CI, 6.1% to 36.9%) of 28 patients with high FGFR2b-overexpressing GEA had a confirmed partial response. Conclusion: Overall, bemarituzumab seems to be well tolerated and demonstrated single-agent activity as late-line therapy in patients with advanced-stage GEA. Bemarituzumab is currently being evaluated in combination with chemotherapy in a phase III trial as front-line therapy for patients with high FGFR2b-overexpressing advanced-stage GEA.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherAmerican Society of Clinical Oncology-
dc.relation.isPartOfJOURNAL OF CLINICAL ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titlePhase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorDaniel V T Catenacci-
dc.contributor.googleauthorDrew Rasco-
dc.contributor.googleauthorJeeyun Lee-
dc.contributor.googleauthorSun Young Rha-
dc.contributor.googleauthorKeun-Wook Lee-
dc.contributor.googleauthorYung Jue Bang-
dc.contributor.googleauthorJohanna Bendell-
dc.contributor.googleauthorPeter Enzinger-
dc.contributor.googleauthorNeyssa Marina-
dc.contributor.googleauthorHong Xiang-
dc.contributor.googleauthorWei Deng-
dc.contributor.googleauthorJanine Powers-
dc.contributor.googleauthorZev A Wainberg-
dc.identifier.doi10.1200/JCO.19.01834-
dc.contributor.localIdA01316-
dc.relation.journalcodeJ01331-
dc.identifier.eissn1527-7755-
dc.identifier.pmid32167861-
dc.contributor.alternativeNameRha, Sun Young-
dc.contributor.affiliatedAuthor라선영-
dc.citation.volume38-
dc.citation.number21-
dc.citation.startPage2418-
dc.citation.endPage2426-
dc.identifier.bibliographicCitationJOURNAL OF CLINICAL ONCOLOGY, Vol.38(21) : 2418-2426, 2020-07-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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