Cited 42 times in
A Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitors
DC Field | Value | Language |
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dc.contributor.author | 김혜련 | - |
dc.contributor.author | 조병철 | - |
dc.contributor.author | 홍민희 | - |
dc.date.accessioned | 2022-12-22T01:51:11Z | - |
dc.date.available | 2022-12-22T01:51:11Z | - |
dc.date.issued | 2022-04 | - |
dc.identifier.issn | 1556-0864 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/191364 | - |
dc.description.abstract | Introduction: This integrated analysis of a phase 1/2 study (NCT03046992) evaluated the efficacy and safety of lazertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced EGFR T790M-positive NSCLC after previous EGFR TKI therapy. Methods: Adults with EGFR mutation-positive NSCLC that progressed after prior EGFR-directed TKIs received once daily oral lazertinib 240 mg continuously until disease progression. Prior TKIs to treat T790M-positive NSCLC were prohibited. Primary endpoints were safety and objective response rate (ORR). Secondary endpoints included progression-free survival, overall survival, and intracranial ORR. Results: A total of 78 patients received lazertinib 240 mg at 17 centers in South Korea. Among patients with T790M-positive tumors at baseline (N = 76), one (1.3%) had a complete response and 41 (53.9%) had partial responses, giving an ORR of 55.3% (95% confidence interval [CI]: 44.1-66.4). Median progression-free survival was 11.1 months (95% CI: 5.5-16.4). Median overall survival was not reached (median follow-up = 22.0 mo). In patients with measurable intracranial lesions (n = 7), one (14.3%) had a complete intracranial response and five (71.4%) had partial responses, giving an intracranial ORR of 85.7% (95% CI: 59.8%-100.0%). The most common treatment-emergent adverse events were rash (37.2%), pruritus (34.6%), and paresthesia (33.3%); most were mild to moderate in severity. Serious drug-related adverse events occurred in three patients (gastritis, pneumonia, pneumonitis). The major mechanism of resistance was EGFR T790M loss. Conclusions: Lazertinib 240 mg/d has a manageable safety profile with durable antitumor efficacy, including brain metastases, in patients with advanced T790M-positive NSCLC after previous EGFR TKI therapy. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF THORACIC ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / chemically induced | - |
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* / chemically induced | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Lung Neoplasms* / genetics | - |
dc.subject.MESH | Morpholines | - |
dc.subject.MESH | Mutation | - |
dc.subject.MESH | Protein Kinase Inhibitors / pharmacology | - |
dc.subject.MESH | Protein Kinase Inhibitors / therapeutic use | - |
dc.subject.MESH | Pyrazoles | - |
dc.subject.MESH | Pyrimidines | - |
dc.title | A Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitors | - |
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 | Ji-Youn Han | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Eun Kyung Cho | - |
dc.contributor.googleauthor | Yun-Gyoo Lee | - |
dc.contributor.googleauthor | Dong-Wan Kim | - |
dc.contributor.googleauthor | Joo-Hang Kim | - |
dc.contributor.googleauthor | Gyeong-Won Lee | - |
dc.contributor.googleauthor | Jong-Seok Lee | - |
dc.contributor.googleauthor | Byoung Yong Shim | - |
dc.contributor.googleauthor | Jin-Soo Kim | - |
dc.contributor.googleauthor | Sang Hoon Chun | - |
dc.contributor.googleauthor | Sung Sook Lee | - |
dc.contributor.googleauthor | Hye Ryun Kim | - |
dc.contributor.googleauthor | Min Hee Hong | - |
dc.contributor.googleauthor | Jin Seok Ahn | - |
dc.contributor.googleauthor | Jong-Mu Sun | - |
dc.contributor.googleauthor | Youngjoo Lee | - |
dc.contributor.googleauthor | Dae Ho Lee | - |
dc.contributor.googleauthor | Ji Ah Kang | - |
dc.contributor.googleauthor | NaMi Lee | - |
dc.contributor.googleauthor | Mi-Jung Kwon | - |
dc.contributor.googleauthor | Carin Espenschied | - |
dc.contributor.googleauthor | Arielle Yablonovitch | - |
dc.contributor.googleauthor | Myung-Ju Ahn | - |
dc.identifier.doi | 10.1016/j.jtho.2021.11.025 | - |
dc.contributor.localId | A01166 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J01909 | - |
dc.identifier.eissn | 1556-1380 | - |
dc.identifier.pmid | 34958928 | - |
dc.subject.keyword | EGFR T790M-positive non-small cell lung cancer (NSCLC) | - |
dc.subject.keyword | Epidermal growth factor receptor (EGFR) | - |
dc.subject.keyword | Lazertinib | - |
dc.subject.keyword | Tyrosine kinase inhibitor (TKI) | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | 김혜련 | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 17 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 558 | - |
dc.citation.endPage | 567 | - |
dc.identifier.bibliographicCitation | JOURNAL OF THORACIC ONCOLOGY, Vol.17(4) : 558-567, 2022-04 | - |
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