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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

 Byoung Chul Cho  ;  Ji-Youn Han  ;  Sang-We Kim  ;  Ki Hyeong Lee  ;  Eun Kyung Cho  ;  Yun-Gyoo Lee  ;  Dong-Wan Kim  ;  Joo-Hang Kim  ;  Gyeong-Won Lee  ;  Jong-Seok Lee  ;  Byoung Yong Shim  ;  Jin-Soo Kim  ;  Sang Hoon Chun  ;  Sung Sook Lee  ;  Hye Ryun Kim  ;  Min Hee Hong  ;  Jin Seok Ahn  ;  Jong-Mu Sun  ;  Youngjoo Lee  ;  Dae Ho Lee  ;  Ji Ah Kang  ;  NaMi Lee  ;  Mi-Jung Kwon  ;  Carin Espenschied  ;  Arielle Yablonovitch  ;  Myung-Ju Ahn 
 JOURNAL OF THORACIC ONCOLOGY, Vol.17(4) : 558-567, 2022-04 
Journal Title
Issue Date
Adult ; Carcinoma, Non-Small-Cell Lung* / chemically induced ; Carcinoma, Non-Small-Cell Lung* / drug therapy ; Carcinoma, Non-Small-Cell Lung* / genetics ; ErbB Receptors / genetics ; Humans ; Lung Neoplasms* / chemically induced ; Lung Neoplasms* / drug therapy ; Lung Neoplasms* / genetics ; Morpholines ; Mutation ; Protein Kinase Inhibitors / pharmacology ; Protein Kinase Inhibitors / therapeutic use ; Pyrazoles ; Pyrimidines
EGFR T790M-positive non-small cell lung cancer (NSCLC) ; Epidermal growth factor receptor (EGFR) ; Lazertinib ; Tyrosine kinase inhibitor (TKI)
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
Hong, Min Hee(홍민희) ORCID logo https://orcid.org/0000-0003-3490-2195
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