A Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitorsopen access
- Cho, Byoung Chul; Han, Ji-Youn; Kim, Sang-We; Lee, Ki Hyeong; Cho, Eun Kyung; Lee, Yun-Gyoo; Kim, Dong-Wan; Kim, Joo-Hang; Lee, Gyeong-Won; Lee, Jong-Seok; Shim, Byoung Yong; Kim, Jin-Soo; Chun, Sang Hoon; Lee, Sung Sook; Kim, Hye Ryun; Hong, Min Hee; Ahn, Jin Seok; Sun, Jong-Mu; Lee, Youngjoo; Lee, Dae Ho; Kang, Ji Ah; Lee, NaMi; Kwon, Mi-Jung; Espenschied, Carin; Yablonovitch, Arielle; Ahn, Myung-Ju
- Issue Date
- ELSEVIER SCIENCE INC
- Lazertinib; Epidermal growth factor receptor (EGFR); Tyrosine kinase inhibitor (TKI); EGFR T790M-positive non-small cell lung cancer (NSCLC)
- JOURNAL OF THORACIC ONCOLOGY, v.17, no.4, pp.558 - 567
- Journal Title
- JOURNAL OF THORACIC ONCOLOGY
- Start Page
- End Page
- 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. (C) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc.
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