PMID- 37402411
OWN - NLM
STAT- MEDLINE
DCOM- 20240117
LR  - 20240118
IS  - 2005-9256 (Electronic)
IS  - 1598-2998 (Print)
IS  - 1598-2998 (Linking)
VI  - 56
IP  - 1
DP  - 2024 Jan
TI  - Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally 
      Advanced or Metastatic NSCLC: LASER301 Korean Subset.
PG  - 48-60
LID - 10.4143/crt.2023.453 [doi]
AB  - PURPOSE: This subgroup analysis of the Korean subset of patients in the phase 3 
      LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib 
      as first-line therapy for epidermal growth factor receptor mutated (EGFRm) 
      non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Patients with locally 
      advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) 
      or gefitinib (250 mg/day). The primary endpoint was investigator-assessed 
      progression-free survival (PFS). RESULTS: In total, 172 Korean patients were 
      enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were 
      balanced between the treatment groups. One-third of patients had brain metastases 
      (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 
      to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib 
      (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS 
      analysis based on blinded independent central review. Significant PFS benefit 
      with lazertinib was consistently observed across predefined subgroups, including 
      patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations 
      (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its 
      previously reported safety profile. Common adverse events (AEs) in both groups 
      included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe 
      treatment-related AEs occurred with lazertinib than gefitinib. CONCLUSION: 
      Consistent with results for the overall LASER301 population, this analysis showed 
      significant PFS benefit with lazertinib versus gefitinib with comparable safety 
      in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new 
      potential treatment option for this patient population.
FAU - Lee, Ki Hyeong
AU  - Lee KH
AD  - Division of Medical Oncology, Department of Medicine, Chungbuk National 
      University Hospital, Chungbuk National University College of Medicine, Cheongju, 
      Korea.
FAU - Cho, Byoung Chul
AU  - Cho BC
AD  - Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer 
      Center, Yonsei University College of Medicine, Seoul, Korea.
FAU - Ahn, Myung-Ju
AU  - Ahn MJ
AD  - Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, 
      Sungkyunkwan University School of Medicine, Seoul, Korea.
FAU - Lee, Yun-Gyoo
AU  - Lee YG
AD  - Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan 
      University School of Medicine, Seoul, Korea.
FAU - Lee, Youngjoo
AU  - Lee Y
AD  - Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, 
      Goyang, Korea.
FAU - Lee, Jong-Seok
AU  - Lee JS
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seoul National University College of Medicine, Seongnam, Korea.
FAU - Kim, Joo-Hang
AU  - Kim JH
AD  - CHA Bundang Medical Center, CHA University, Seongnam, Korea.
FAU - Min, Young Joo
AU  - Min YJ
AD  - Division of Hematology and Oncology, Department of Internal Medicine, Ulsan 
      University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
FAU - Lee, Gyeong-Won
AU  - Lee GW
AD  - Division of Hemato-Oncology, Department of Internal Medicine, Gyeongsang National 
      University Hospital, Gyeongsang National University, College of Medicine, Jinju, 
      Korea.
FAU - Lee, Sung Sook
AU  - Lee SS
AD  - Inje University Haeundae Paik Hospital, Inje University College of Medicine, 
      Busan, Korea.
FAU - Lee, Kyung-Hee
AU  - Lee KH
AD  - Division of Hematology/Oncology, Department of Internal Medicine, Yeungnam 
      University Medical Center, Daegu, Korea.
FAU - Ko, Yoon Ho
AU  - Ko YH
AD  - Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of 
      Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Shim, Byoung Yong
AU  - Shim BY
AD  - Division of Medical Oncology, Department of Internal Medicine, St. Vincent's 
      Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
FAU - Kim, Sang-We
AU  - Kim SW
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Shin, Sang Won
AU  - Shin SW
AD  - Division of Oncology/Hematology, Department of Internal Medicine, Korea 
      University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
FAU - Choi, Jin-Hyuk
AU  - Choi JH
AD  - Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, 
      Korea.
FAU - Kim, Dong-Wan
AU  - Kim DW
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
FAU - Cho, Eun Kyung
AU  - Cho EK
AD  - Division of Oncology, Department of Internal Medicine, Gil Medical Center, Gachon 
      University College of Medicine, Incheon, Korea.
FAU - Park, Keon Uk
AU  - Park KU
AD  - Division of Hematology/Oncology, Department of Internal Medicine, Keimyung 
      University Dongsan Hospital, Daegu, Korea.
FAU - Kim, Jin-Soo
AU  - Kim JS
AD  - Department of Internal Medicine, Seoul Metropolitan Government Seoul National 
      University Boramae Medical Center, Seoul, Korea.
FAU - Chun, Sang Hoon
AU  - Chun SH
AD  - Division of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary's 
      Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Wang, Jangyoung
AU  - Wang J
AD  - Yuhan Corporation, Seoul, Korea.
FAU - Choi, SeokYoung
AU  - Choi S
AD  - Yuhan Corporation, Seoul, Korea.
FAU - Kang, Jin Hyoung
AU  - Kang JH
AD  - Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's 
      Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
LA  - eng
GR  - Yuhan Corporation/
GR  - Tech Observer Asia Pacific Pte Ltd./
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230627
PL  - Korea (South)
TA  - Cancer Res Treat
JT  - Cancer research and treatment
JID - 101155137
RN  - S65743JHBS (Gefitinib)
RN  - 4A2Y23XK11 (lazertinib)
RN  - 0 (Quinazolines)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - 0 (Morpholines)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyrimidines)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics
MH  - Gefitinib/therapeutic use
MH  - *Lung Neoplasms/drug therapy/genetics
MH  - Quinazolines
MH  - ErbB Receptors/genetics/metabolism
MH  - Republic of Korea
MH  - Mutation
MH  - Protein Kinase Inhibitors/adverse effects
MH  - *Morpholines
MH  - *Pyrazoles
MH  - *Pyrimidines
PMC - PMC10789945
OTO - NOTNLM
OT  - EGFR mutation
OT  - Lazertinib
OT  - Non-small-cell lung carcinoma
COIS- Conflicts of Interest Ki Hyeong Lee reports participation in advisory boards and 
      honoraria from BMS, MSD, AstraZeneca, Pfizer, Eli Lilly, Yuhan Corporation, and 
      research funding from Merck outside the submitted work. Byoung Chul Cho has 
      received research funding from MOGAM Institute, LG Chem, Oscotec, Interpark Bio 
      Convergence Corp, GIInnovation, GI-Cell, Abion, Abbvie, AstraZeneca, Bayer, 
      Blueprint Medicines, Boehringer Ingelheim, Champions Oncology, CJ bioscience, CJ 
      Blossom Park, Cyrus, Dizal Pharma, Genexine, Janssen, Lilly, MSD, Novartis, 
      Nuvalent, Oncternal, Ono, Regeneron, Dong-A ST, Bridgebio Therapeutics, Yuhan 
      Corporation, ImmuneOncia, Illumina, KANAPH Therapeutics Inc., Therapex, JINTSbio, 
      Hanmi and CHA Bundang Medical Center. He has received consulting fees from Abion, 
      BeiGene, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, CJ, CureLogen, 
      Cyrus Therapeutics, Ono Pharmaceutical, Onegene Biotechnology, Yuhan Corporation, 
      Pfizer, Eli Lilly, GI-Cell, Guardant, HK Inno-N, Imnewrun Biosciences Inc., 
      Janssen, Takeda, MSD, Janssen, Medpacto, Blueprint Medicines, RandBio, and Hanmi. 
      He receives royalty from Champions Oncology, Crown Bioscience, Imagen and serves 
      on the advisory board of KANAPH Therapeutics Inc., Bridgebio Therapeutics, Cyrus 
      Therapeutics, Guardant Health, and Oscotech Inc. He was an invited speaker for 
      ASCO, AstraZeneca, Guardant, Roche, ESMO, IASLC, Korean Cancer Association, 
      Korean Society of Medical Oncology, Korean Society of Thyroid-Head and Neck 
      Surgery, Korean Cancer Study Group, Novartis, MSD, The Chinese Thoracic Oncology 
      Society, and Pfizer. He is on the board of directors for Interpark Bio 
      Convergence Corp., and J INTS BIO. He is a founder of the DAAN Biotherapeutics 
      and owns stocks of TheraCanVac Inc., Gencurix Inc., Bridgebio Therapeutics, 
      KANAPH Therapeutics Inc., Cyrus therapeutics, Interpark Bio Convergence Corp., 
      and J INTS BIO. Myung-Ju Ahn reports research funding from AstraZeneca, Lilly, 
      MSD, Merck, Ono Pharmaceutical, Takeda, Yuhan Corporation, Amgen, Pfizer, 
      Novartis, Roche, Alpha-Pharmaceuticals and honoraria from AstraZeneca, Lilly, 
      MSD, Merck, Ono, Takeda, Yuhan Corporation, Amgen, Pfizer, Novartis and Roche. 
      Youngjoo Lee reports consulting fees from Roche, Merck, Yuhan Corporation, and 
      Bayer. Joo-Hang Kim received grants from AstraZeneca, Yuhan Corporation, Roche, 
      Amgen, and BeiGene. Young Joo Min reports research funding from AstraZeneca, MSD, 
      Merck, Ono Pharmaceutical, Yuhan Corporation, AMGEN, Roche and honoraria from 
      AstraZeneca, MSD, Merck, and Ono Pharmaceutical. Jin-Hyuk Choi reports research 
      funding from AstraZeneca, Roche, and Samyang Holdings Korea. Dong-Wan Kim reports 
      research funding to his institution from Alpha Biopharma, Amgen, 
      Astrazeneca/Medimmune, Boehringer-Ingelheim, BMS, Bridgebio Therapeutics, Chong 
      Keun Dang, Daiichi-Sankyo, GSK, Hanmi, InnoN, Janssen, Merck, Merus, Mirati 
      Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, 
      TP Therapeutics, Xcovery, and Yuhan Corporation. Jin Hyoung Kang reports research 
      funding from AstraZeneca, Ono Pharma Korea, Daiichi Sankyo/UCB Japan, Yuhan 
      Corporation and received honoraria from AstraZeneca, Ono Pharmaceutical, Lilly 
      and Boehringer Ingelheim. He is a consultant for MSD Oncology, AstraZeneca, Ono 
      Pharmaceutical, Boehringer Ingelheim, Yuhan Corporation, Genexine and was invited 
      speaker for Boehringer Ingelheim, Pfizer and Roche. Jangyoung Wang and SeokYoung 
      Choi are employees of Yuhan Corporation. All other authors have no relevant 
      relationships to disclose. The study was sponsored by Yuhan Corporation. The 
      study sponsor funded medical writing and editorial support for the publication.
EDAT- 2023/07/05 01:06
MHDA- 2024/01/17 06:43
PMCR- 2024/01/01
CRDT- 2023/07/04 19:10
PHST- 2023/03/09 00:00 [received]
PHST- 2023/06/23 00:00 [accepted]
PHST- 2024/01/17 06:43 [medline]
PHST- 2023/07/05 01:06 [pubmed]
PHST- 2023/07/04 19:10 [entrez]
PHST- 2024/01/01 00:00 [pmc-release]
AID - crt.2023.453 [pii]
AID - crt-2023-453 [pii]
AID - 10.4143/crt.2023.453 [doi]
PST - ppublish
SO  - Cancer Res Treat. 2024 Jan;56(1):48-60. doi: 10.4143/crt.2023.453. Epub 2023 Jun 
      27.