한빛사 논문
Byoung Chul Cho MD, PhDa, Ji-Youn Han MD, PhDb, Sang-We Kim MD, PhDc, Ki Hyeong Lee MD, PhDd, Eun Kyung Cho MD, PhDe, Yun-Gyoo Lee MD, PhDf, Dong-Wan Kim MD, PhDg, Joo-Hang Kim MD, PhDh, Gyeong-Won Lee MD, PhDi, Jong-Seok Lee MD, PhDj, Byoung Yong Shim MD, PhDk, Jin-Soo Kim MD, PhDl, Sang Hoon Chun MD, PhDm, Sung Sook Lee MD, PhDn, Hye Ryun Kim MD, PhDa, Min Hee Hong MDa, Jin Seok Ahn MD, PhDo, Jong-Mu Sun MD, PhDo, Youngjoo Lee MD, PhDb, Dae Ho Lee MD, PhDc, Ji Ah Kang MSp, NaMi Lee MSp, Mi-Jung Kwon PhDp, Carin Espenschied MSq, Arielle Yablonovitch PhDq, Myung-Ju Ahn MD, PhDo,*
aDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50-1, Yonsei-Ro, Seodaemun-gu, Seoul 03722, Republic of Korea
bCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 10408, Republic of Korea
cDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
dDivision of Medical Oncology, Department of Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, 776, 1Sunhwan-ro, Seowon-gu, Cheongju-si, Chungcheongbuk-do 28644, Republic of Korea
eGachon University Gil Medical Center, Gachon University College of Medicine, 21, Namdong-daero 774 beon-gil, Namdong-gu, Incheon 21565, Republic of Korea
fDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29, Saemunan-ro, Jongno-gu, Seoul 03181, Republic of Korea
gDepartment of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, 101, Daehak-ro Jongno-gu, Seoul 03080, Republic of Korea
hCHA Bundang Medical Center, CHA University, 59, Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do 13496, Republic of Korea
iDivision of Hematology and Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, 79, Gangnam-ro, Jinju-si, Gyeongsangnam-do, 52727, Republic of Korea
jDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University, College of Medicine, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 1362, Republic of Korea
kDepartment of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do 16247, Republic of Korea
lDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul 07061, Republic of Korea
mDivision of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, The Catholic University of Korea, 327, Sosa-ro, Bucheon-si, Gyeonggi-do 14647, Republic of Korea
nInje University Haeundae Paik Hospital, Inje University College of Medicine, 875, Haeun-daero, Haeundae-gu, Busan 48108, Republic of Korea
oDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, 81 Irwon-Ro Gangnam-gu. Seoul 06351, Republic of Korea
pClinical Development Department, Yuhan Corporation, 74, Noryangjin-ro, Daebang-dong, Dongjak-gu, Seoul 06927, Republic of Korea
qGuardant Health, Inc., 505 Penobscot Drive, Redwood City, CA 94063, United States of America
*Corresponding author.
Abstract
Introduction
This integrated analysis of a phase 1/2 study (NCT03046992) assessed the efficacy and safety of lazertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), in patients with advanced EGFR T790M-positive non-small cell lung cancer (NSCLC) after prior 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
Seventy-eight patients received lazertinib 240 mg at 17 centers in South Korea. Among patients with T790M-positive tumors at baseline (n=76), 1 (1.3%) had a complete response and 41 (53.9%) had partial responses, giving an ORR of 55.3% (95% 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 months). In patients with measurable intracranial lesions (n=7), 1 (14.3%) had a complete intracranial response and 5 (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 3 patients (gastritis, pneumonia, pneumonitis). The major mechanism of resistance was EGFR T790M loss.
Conclusions
Lazertinib 240 mg/day has a manageable safety profile with durable antitumor efficacy, including brain metastases, in patients with advanced T790M-positive NSCLC after prior EGFR TKI therapy.
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