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Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma
DC Field | Value | Language |
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dc.contributor.author | Catenacci, Daniel V. T. | - |
dc.contributor.author | Rasco, Drew | - |
dc.contributor.author | Lee, Jeeyun | - |
dc.contributor.author | Rha, Sun Young | - |
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Bang, Yung Jue | - |
dc.contributor.author | Bendell, Johanna | - |
dc.contributor.author | Enzinger, Peter | - |
dc.contributor.author | Marina, Neyssa | - |
dc.contributor.author | Xiang, Hong | - |
dc.contributor.author | Deng, Wei | - |
dc.contributor.author | Powers, Janine | - |
dc.contributor.author | Wainberg, Zev A. | - |
dc.date.accessioned | 2021-01-31T12:00:27Z | - |
dc.date.available | 2021-01-31T12:00:27Z | - |
dc.date.created | 2020-10-27 | - |
dc.date.created | 2020-10-27 | - |
dc.date.issued | 2020-07 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.38 No.21, pp.2418-2426 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 114035 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173202 | - |
dc.description.abstract | PURPOSETo evaluate the safety, pharmacokinetics, and preliminary activity of bemarituzumab in patients with FGFR2b-overexpressing gastric and gastroesophageal junction adenocarcinoma (GEA).PATIENTS AND METHODSFPA144-001 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.RESULTSSeventy-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.CONCLUSIONOverall, 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.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1200/JCO.19.01834 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000559984900008 | - |
dc.identifier.scopusid | 2-s2.0-85087787828 | - |
dc.citation.endpage | 2426 | - |
dc.citation.number | 21 | - |
dc.citation.startpage | 2418 | - |
dc.citation.volume | 38 | - |
dc.identifier.sci | 000559984900008 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Lee, Keun-Wook | - |
dc.contributor.affiliatedAuthor | Bang, Yung Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | GROWTH-FACTOR | - |
dc.subject.keywordPlus | GASTRIC-CANCER | - |
dc.subject.keywordPlus | GENE AMPLIFICATION | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | DOSE-ESCALATION | - |
dc.subject.keywordPlus | JUNCTION | - |
dc.subject.keywordPlus | FGFR2 | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | OVEREXPRESSION | - |
dc.subject.keywordPlus | HETEROGENEITY | - |
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