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Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2023-11-28T03:33:02Z | - |
dc.date.available | 2023-11-28T03:33:02Z | - |
dc.date.issued | 2023-10 | - |
dc.identifier.issn | 1078-8956 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/196850 | - |
dc.description.abstract | Patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) often develop resistance to current standard third-generation EGFR tyrosine kinase inhibitors (TKIs); no targeted treatments are approved in the osimertinib-relapsed setting. In this open-label, dose-escalation and dose-expansion phase 1 trial, the potential for improved anti-tumor activity by combining amivantamab, an EGFR-MET bispecific antibody, with lazertinib, a third-generation EGFR TKI, was evaluated in patients with EGFR-mutant NSCLC whose disease progressed on third-generation TKI monotherapy but were chemotherapy naive (CHRYSALIS cohort E). In the dose-escalation phase, the recommended phase 2 combination dose was established; in the dose-expansion phase, the primary endpoints were safety and overall response rate, and key secondary endpoints included progression-free survival and overall survival. The safety profile of amivantamab and lazertinib was generally consistent with previous experience of each agent alone, with 4% experiencing grade ≥3 events; no new safety signals were identified. In an exploratory cohort of 45 patients who were enrolled without biomarker selection, the primary endpoint of investigator-assessed overall response rate was 36% (95% confidence interval, 22-51). The median duration of response was 9.6 months, and the median progression-free survival was 4.9 months. Next-generation sequencing and immunohistochemistry analyses identified high EGFR and/or MET expression as potential predictive biomarkers of response, which will need to be validated with prospective assessment. ClinicalTrials.gov identifier: NCT02609776 . | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Nature Publishing Company | - |
dc.relation.isPartOf | NATURE MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aniline Compounds / therapeutic use | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / genetics | - |
dc.subject.MESH | ErbB Receptors / genetics | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Lung Neoplasms* / genetics | - |
dc.subject.MESH | Mutation / genetics | - |
dc.subject.MESH | Prospective Studies | - |
dc.subject.MESH | Protein Kinase Inhibitors / pharmacology | - |
dc.subject.MESH | Protein Kinase Inhibitors / therapeutic use | - |
dc.title | Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial | - |
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 | Dong-Wan Kim | - |
dc.contributor.googleauthor | Alexander I Spira | - |
dc.contributor.googleauthor | Jorge E Gomez | - |
dc.contributor.googleauthor | Eric B Haura | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Rachel E Sanborn | - |
dc.contributor.googleauthor | Eun Kyung Cho | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Anna Minchom | - |
dc.contributor.googleauthor | Jong-Seok Lee | - |
dc.contributor.googleauthor | Ji-Youn Han | - |
dc.contributor.googleauthor | Misako Nagasaka | - |
dc.contributor.googleauthor | Joshua K Sabari | - |
dc.contributor.googleauthor | Sai-Hong Ignatius Ou | - |
dc.contributor.googleauthor | Patricia Lorenzini | - |
dc.contributor.googleauthor | Joshua M Bauml | - |
dc.contributor.googleauthor | Joshua C Curtin | - |
dc.contributor.googleauthor | Amy Roshak | - |
dc.contributor.googleauthor | Grace Gao | - |
dc.contributor.googleauthor | John Xie | - |
dc.contributor.googleauthor | Meena Thayu | - |
dc.contributor.googleauthor | Roland E Knoblauch | - |
dc.contributor.googleauthor | Keunchil Park | - |
dc.identifier.doi | 10.1038/s41591-023-02554-7 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02296 | - |
dc.identifier.eissn | 1546-170X | - |
dc.identifier.pmid | 37710001 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 29 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 2577 | - |
dc.citation.endPage | 2585 | - |
dc.identifier.bibliographicCitation | NATURE MEDICINE, Vol.29(10) : 2577-2585, 2023-10 | - |
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