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Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study
DC Field | Value | Language |
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dc.contributor.author | 최혜진 | - |
dc.date.accessioned | 2024-03-22T06:20:11Z | - |
dc.date.available | 2024-03-22T06:20:11Z | - |
dc.date.issued | 2023-07 | - |
dc.identifier.issn | 1470-2045 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198532 | - |
dc.description.abstract | Background: HER2 is overexpressed or amplified in a subset of biliary tract cancer. Zanidatamab, a bispecific antibody targeting two distinct HER2 epitopes, exhibited tolerability and preliminary anti-tumour activity in HER2-expressing or HER2 (also known as ERBB2)-amplified treatment-refractory biliary tract cancer. Methods: HERIZON-BTC-01 is a global, multicentre, single-arm, phase 2b trial of zanidatamab in patients with HER2-amplified, unresectable, locally advanced, or metastatic biliary tract cancer with disease progression on previous gemcitabine-based therapy, recruited at 32 clinical trial sites in nine countries in North America, South America, Asia, and Europe. Eligible patients were aged 18 years or older with HER2-amplified biliary tract cancer confirmed by in-situ hybridisation per central testing, at least one measurable target lesion per Response Evaluation Criteria in Solid Tumours (version 1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were assigned into cohorts based on HER2 immunohistochemistry (IHC) score: cohort 1 (IHC 2+ or 3+; HER2-positive) and cohort 2 (IHC 0 or 1+). Patients received zanidatamab 20 mg/kg intravenously every 2 weeks. The primary endpoint was confirmed objective response rate in cohort 1 as assessed by independent central review. Anti-tumour activity and safety were assessed in all participants who received any dose of zanidatamab. This trial is registered with ClinicalTrials.gov, NCT04466891, is ongoing, and is closed to recruitment. Findings: Between Sept 15, 2020, and March 16, 2022, 87 patients were enrolled in HERIZON-BTC-01: 80 in cohort 1 (45 [56%] were female and 35 [44%] were male; 52 [65%] were Asian; median age was 64 years [IQR 58–70]) and seven in cohort 2 (five [71%] were male and two [29%] were female; five [71%] were Asian; median age was 62 years [IQR 58–77]). At the time of the data cutoff (Oct 10, 2022), 18 (21%) patients (17 in cohort 1 and one in cohort 2) were continuing to receive zanidatamab; 69 (79%) discontinued treatment (radiographic progression in 64 [74%] patients). The median duration of follow-up was 12·4 months (IQR 9·4–17·2). Confirmed objective responses by independent central review were observed in 33 patients in cohort 1 (41·3% [95% CI 30·4–52·8]). 16 (18%) patients had grade 3 treatment-related adverse events; the most common were diarrhoea (four [5%] patients) and decreased ejection fraction (three [3%] patients). There were no grade 4 treatment-related adverse events and no treatment-related deaths. Interpretation: Zanidatamab demonstrated meaningful clinical benefit with a manageable safety profile in patients with treatment-refractory, HER2-positive biliary tract cancer. These results support the potential of zanidatamab as a future treatment option in HER2-positive biliary tract cancer. Funding: Zymeworks, Jazz, and BeiGene. © 2023 Elsevier Ltd | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Lancet Pub. Group | - |
dc.relation.isPartOf | LANCET ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Agents* / adverse effects | - |
dc.subject.MESH | Antineoplastic Agents* / therapeutic use | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use | - |
dc.subject.MESH | Bile Duct Neoplasms* / drug therapy | - |
dc.subject.MESH | Biliary Tract Neoplasms* / drug therapy | - |
dc.subject.MESH | Biliary Tract Neoplasms* / genetics | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Gemcitabine | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.title | Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | James J Harding | - |
dc.contributor.googleauthor | Jia Fan | - |
dc.contributor.googleauthor | Do-Youn Oh | - |
dc.contributor.googleauthor | Hye Jin Choi | - |
dc.contributor.googleauthor | Jin Won Kim | - |
dc.contributor.googleauthor | Heung-Moon Chang | - |
dc.contributor.googleauthor | Lequn Bao | - |
dc.contributor.googleauthor | Hui-Chuan Sun | - |
dc.contributor.googleauthor | Teresa Macarulla | - |
dc.contributor.googleauthor | Feng Xie | - |
dc.contributor.googleauthor | Jean-Phillippe Metges | - |
dc.contributor.googleauthor | Jie'er Ying | - |
dc.contributor.googleauthor | John Bridgewater | - |
dc.contributor.googleauthor | Myung-Ah Lee | - |
dc.contributor.googleauthor | Mohamedtaki A Tejani | - |
dc.contributor.googleauthor | Emerson Y Chen | - |
dc.contributor.googleauthor | Dong Uk Kim | - |
dc.contributor.googleauthor | Harpreet Wasan | - |
dc.contributor.googleauthor | Michel Ducreux | - |
dc.contributor.googleauthor | Yuanyuan Bao | - |
dc.contributor.googleauthor | Lisa Boyken | - |
dc.contributor.googleauthor | Jiafang Ma | - |
dc.contributor.googleauthor | Phillip Garfin | - |
dc.contributor.googleauthor | Shubham Pant | - |
dc.contributor.googleauthor | HERIZON-BTC-01 study group | - |
dc.identifier.doi | 10.1016/S1470-2045(23)00242-5 | - |
dc.contributor.localId | A04219 | - |
dc.relation.journalcode | J02154 | - |
dc.identifier.eissn | 1474-5488 | - |
dc.identifier.pmid | 37276871 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S1470204523002425 | - |
dc.contributor.alternativeName | Choi, Hye Jin | - |
dc.contributor.affiliatedAuthor | 최혜진 | - |
dc.citation.volume | 24 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 772 | - |
dc.citation.endPage | 782 | - |
dc.identifier.bibliographicCitation | LANCET ONCOLOGY, Vol.24(7) : 772-782, 2023-07 | - |
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