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A Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitors

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dc.contributor.author김혜련-
dc.contributor.author조병철-
dc.contributor.author홍민희-
dc.date.accessioned2022-12-22T01:51:11Z-
dc.date.available2022-12-22T01:51:11Z-
dc.date.issued2022-04-
dc.identifier.issn1556-0864-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/191364-
dc.description.abstractIntroduction: 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.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfJOURNAL OF THORACIC ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung* / chemically induced-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung* / drug therapy-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung* / genetics-
dc.subject.MESHErbB Receptors / genetics-
dc.subject.MESHHumans-
dc.subject.MESHLung Neoplasms* / chemically induced-
dc.subject.MESHLung Neoplasms* / drug therapy-
dc.subject.MESHLung Neoplasms* / genetics-
dc.subject.MESHMorpholines-
dc.subject.MESHMutation-
dc.subject.MESHProtein Kinase Inhibitors / pharmacology-
dc.subject.MESHProtein Kinase Inhibitors / therapeutic use-
dc.subject.MESHPyrazoles-
dc.subject.MESHPyrimidines-
dc.titleA Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitors-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorJi-Youn Han-
dc.contributor.googleauthorSang-We Kim-
dc.contributor.googleauthorKi Hyeong Lee-
dc.contributor.googleauthorEun Kyung Cho-
dc.contributor.googleauthorYun-Gyoo Lee-
dc.contributor.googleauthorDong-Wan Kim-
dc.contributor.googleauthorJoo-Hang Kim-
dc.contributor.googleauthorGyeong-Won Lee-
dc.contributor.googleauthorJong-Seok Lee-
dc.contributor.googleauthorByoung Yong Shim-
dc.contributor.googleauthorJin-Soo Kim-
dc.contributor.googleauthorSang Hoon Chun-
dc.contributor.googleauthorSung Sook Lee-
dc.contributor.googleauthorHye Ryun Kim-
dc.contributor.googleauthorMin Hee Hong-
dc.contributor.googleauthorJin Seok Ahn-
dc.contributor.googleauthorJong-Mu Sun-
dc.contributor.googleauthorYoungjoo Lee-
dc.contributor.googleauthorDae Ho Lee-
dc.contributor.googleauthorJi Ah Kang-
dc.contributor.googleauthorNaMi Lee-
dc.contributor.googleauthorMi-Jung Kwon-
dc.contributor.googleauthorCarin Espenschied-
dc.contributor.googleauthorArielle Yablonovitch-
dc.contributor.googleauthorMyung-Ju Ahn-
dc.identifier.doi10.1016/j.jtho.2021.11.025-
dc.contributor.localIdA01166-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ01909-
dc.identifier.eissn1556-1380-
dc.identifier.pmid34958928-
dc.subject.keywordEGFR T790M-positive non-small cell lung cancer (NSCLC)-
dc.subject.keywordEpidermal growth factor receptor (EGFR)-
dc.subject.keywordLazertinib-
dc.subject.keywordTyrosine kinase inhibitor (TKI)-
dc.contributor.alternativeNameKim, Hye Ryun-
dc.contributor.affiliatedAuthor김혜련-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume17-
dc.citation.number4-
dc.citation.startPage558-
dc.citation.endPage567-
dc.identifier.bibliographicCitationJOURNAL OF THORACIC ONCOLOGY, Vol.17(4) : 558-567, 2022-04-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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