
PMID- 41474069
OWN - NLM
STAT- MEDLINE
DCOM- 20260307
LR  - 20260813
IS  - 1097-0215 (Electronic)
IS  - 0020-7136 (Print)
IS  - 0020-7136 (Linking)
VI  - 158
IP  - 9
DP  - 2026 May 1
TI  - Five-year outcomes of pembrolizumab versus chemotherapy in Chinese patients with 
      non-small-cell lung cancer and programmed cell death ligand 1 tumor proportion 
      score >/=1%: KEYNOTE-042 China study.
PG  - 2429-2439
LID - 10.1002/ijc.70265 [doi]
AB  - In the phase 3 KEYNOTE-042 China study of participants enrolled in China in the 
      global KEYNOTE-042 (NCT02220894) and China extension (NCT03850444) studies, 
      pembrolizumab improved overall survival (OS) versus chemotherapy in locally 
      advanced or metastatic non-small-cell lung cancer (NSCLC) with programmed cell 
      death ligand 1 (PD-L1) tumor proportion score (TPS) >/=50% (hazard ratio [HR], 
      0.63; 95% CI, 0.43-0.94), >/=20% (0.66; 0.47-0.92), and >/=1% (0.67; 0.50-0.89). We 
      present outcomes from this study after 5 years of follow-up. Chinese participants 
      with previously untreated locally advanced or metastatic NSCLC with PD-L1 TPS >/=1% 
      without EGFR or ALK alterations were eligible. Participants were randomized 1:1 
      to pembrolizumab 200 mg every 3 weeks for up to 35 cycles or carboplatin plus 
      paclitaxel or pemetrexed with optional pemetrexed maintenance (nonsquamous only). 
      Primary endpoints were OS in the PD-L1 TPS >/=50%, >/=20%, and >/=1% subgroups. Median 
      follow-up was 63.7 (range, 56.3-72.6) months among 262 participants 
      (pembrolizumab, n = 128; chemotherapy, n = 134) included in this study. 
      Pembrolizumab prolonged OS versus chemotherapy in participants with PD-L1 TPS 
      >/=50% (HR, 0.65; 95% CI, 0.45-0.93), >/=20% (0.67; 0.49-0.91), and >/=1% (0.66; 
      0.51-0.87). Grade 3 to 5 treatment-related AEs occurred in 19.5% and 68.8% of 
      participants in the pembrolizumab and chemotherapy groups, respectively. In 
      conclusion, after 5 years of follow-up, pembrolizumab continued to demonstrate 
      improved OS versus chemotherapy with manageable safety in Chinese participants 
      with previously untreated locally advanced or metastatic NSCLC that expressed 
      PD-L1. These data further support pembrolizumab monotherapy as a standard of care 
      for these patients.
CI  - (c) 2025 Merck & Co., Inc and The Author(s). International Journal of Cancer 
      published by John Wiley & Sons Ltd on behalf of UICC.
FAU - Wu, Yi-Long
AU  - Wu YL
AUID- ORCID: 0000-0002-3611-0258
AD  - Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital 
      (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 
      China.
FAU - Zhang, Li
AU  - Zhang L
AD  - Respiratory Medicine Department, Peking Union Medical College Hospital, Beijing, 
      China.
FAU - Fan, Yun
AU  - Fan Y
AUID- ORCID: 0000-0003-1755-0175
AD  - Department of Thoracic Medical Oncology, The Cancer Hospital of the University of 
      Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.
FAU - Zhou, JianYing
AU  - Zhou J
AD  - Department of Respiratory Medicine, The First Affiliated Hospital of Zhejiang 
      University, Hangzhou, China.
FAU - Zhang, Li
AU  - Zhang L
AD  - Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, 
      China.
FAU - Zhou, Qing
AU  - Zhou Q
AD  - Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital 
      (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 
      China.
FAU - Li, Wei
AU  - Li W
AD  - Oncology Department, The First Hospital of Jilin University, Changchun, China.
FAU - Hu, ChengPing
AU  - Hu C
AD  - Department of Respiratory Medicine, Xiangya Hospital-Central South University, 
      Changsha, China.
FAU - Chen, GongYan
AU  - Chen G
AD  - Department of Respiratory Medicine, The Third Affiliated Hospital of Harbin 
      Medical University, Harbin, China.
FAU - Zhang, Xin
AU  - Zhang X
AD  - Respiratory Diseases Department, Zhongshan Hospital, Fudan University, Shanghai, 
      China.
FAU - Zhou, CaiCun
AU  - Zhou C
AD  - School of Medicine, Tongji University and Shanghai Pulmonary Hospital, Shanghai, 
      China.
FAU - Arenas, Carmen Gonzalez
AU  - Arenas CG
AD  - Oncology European Clinical Development, Merck Research Laboratories, GCD, MSD 
      Spain, Madrid, Spain.
FAU - Chen, Zhenghong
AU  - Chen Z
AD  - Medical Oncology, MSD China, Beijing, China.
FAU - Yu, Wen Cheng
AU  - Yu WC
AD  - Medical Oncology, MSD China, Beijing, China.
FAU - Mok, Tony S K
AU  - Mok TSK
AD  - State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, 
      Hong Kong, China.
LA  - eng
GR  - Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA/
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20251231
PL  - United States
TA  - Int J Cancer
JT  - International journal of cancer
JID - 0042124
RN  - DPT0O3T46P (pembrolizumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (CD274 protein, human)
RN  - Chinese people
SB  - IM
MH  - Humans
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/pathology/mortality
MH  - *Antibodies, Monoclonal, Humanized/therapeutic use/administration & 
      dosage/adverse effects
MH  - *Lung Neoplasms/drug therapy/pathology/mortality
MH  - *B7-H1 Antigen/metabolism/antagonists & inhibitors
MH  - Male
MH  - Female
MH  - Middle Aged
MH  - China
MH  - Aged
MH  - *Antineoplastic Combined Chemotherapy Protocols/therapeutic use/adverse effects
MH  - Adult
MH  - Follow-Up Studies
MH  - Treatment Outcome
MH  - East Asian People
PMC - PMC12963706
OTO - NOTNLM
OT  - chemotherapy
OT  - non-small-cell lung cancer
OT  - pembrolizumab
OT  - programmed cell death ligand 1
COIS- Yi-Long Wu: Grants and research support from AstraZeneca, Boehringer Ingelheim, 
      BMS, Hengrui, and Roche; Advisor/Board member for AstraZeneca, Boehringer 
      Ingelheim, Novartis, Takeda, and MSD; and Honorarium from AstraZeneca, Beigen, 
      Boehringer Ingelheim, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche, and Sanofi 
      (none were promotional activities). Li Zhang, Yun Fan, JianYing Zhou, Wei Li, 
      ChengPing Hu, GongYan Chen, and Xin Zhang: Merck Sharp & Dohme LLC, a subsidiary 
      of Merck & Co., Inc., Rahway, NJ, USA provided funding support for study conduct 
      and medical writing. Li Zhang: Research grants from Hengrui, BMS, and Innovent 
      Biologics. Qing Zhou: Honoraria from AstraZeneca, Lilly, Roche, Pfizer, 
      Boehringer Ingelheim, MSD Oncology, Bristol-Myers Squibb, Hengrui, and BeOne 
      Medicines Ltd outside the submitted work. CaiCun Zhou: Honoraria from Boehringer 
      Ingelheim, Eli Lilly, Hengrui, MSD, Sanofi, F. Hoffmann-La Roche Ltd., and Qilu. 
      Carmen Gonzalez Arenas: Employee of MSD Spain and owns stock in Merck & Co., 
      Inc., Rahway, NJ, USA. Zhenghong Chen and Wen Cheng Yu: Employees of MSD China. 
      Tony S.K. Mok: Received grants or research support from AstraZeneca, Bristol 
      Myers Squibb, G1 Therapeutics, MSD, Merck Serono, Novartis, Pfizer, Roche, SFJ 
      Pharmaceuticals, and XCovery; speaker fees from AbbVie Inc., ACEA Pharma, 
      Adagene, Alentis Therapeutics AG, Alpha Biopharma Co., Ltd., Amgen, Amoy 
      Diagnostics Co., Ltd., AnHeart Therapeutics, AstraZeneca (before January 1, 
      2019), AVEO Pharmaceuticals, Inc., Bayer Healthcare Pharmaceuticals Ltd., 
      BeiGene, BerGenBio ASA, Berry Oncology, Boehringer Ingelheim, Blueprint Medicines 
      Corporation, BMS, Bowtie Life Insurance Company Limited, Bridge Biotherapeutics 
      Inc., Covidien LP, C4 Therapeutics Inc., Cirina Ltd., CStone Pharmaceuticals, 
      Curio Science, D3 Bio Ltd., Da Volterra, Daiichi Sankyo, Eisai, Elevation 
      Oncology, F. Hoffmann-La Roche Ltd., Genentech, GLG's Healthcare, Fishawack 
      Facilitate Ltd., G1 Therapeutics Inc., geneDecode Co., Ltd, Gilead Sciences, Inc. 
      Gritstone Oncology, Inc., Guardant Health, Hengrui Therapeutics Inc., HutchMed, 
      Ignyta, Inc., Illumina, Inc., Incyte Corporation, Inivata, InxMed (Hong Kong) 
      Limited, IQVIA, Janssen, Lakeshore Biotech Ltd, Lilly, Lunit USA, Inc., 
      Loxo-Oncology, Lucence Health Inc., Medscape LLC/WebMD, Medtronic, Merck Serono, 
      MSD, Mirati Therapeutics Inc., MiRXES, MoreHealth, Ningbo NewBay Technology 
      Development Co., Ltd, Novartis, Novocure GmbH, Omega Therapeutics Inc., OrigiMed, 
      OSE Immunotherapeutics, Phanes Therapeutics, Inc., PeerVoice, Pfizer, PrIME 
      Oncology, Prenetics, Puma Biotechnology Inc., Qiming Development (HK) Ltd., 
      Regeneron Pharmaceuticals Inc., Roche Pharmaceuticals/Diagnostics/Foundation One, 
      Sanofi-Aventis, Schrodinger, Inc., SFJ Pharmaceutical Ltd., Simcere of America 
      Inc., Summit Therapeutics Sub, Inc., Synergy Research, Takeda Pharmaceuticals HK 
      Ltd., Tigermed, Vertex Pharmaceuticals, Virtus Medical Group, XENCOR, Inc., and 
      Yuhan Corporation; is a stockholder in Alentis Therapeutics AG, AstraZeneca, 
      Aurora Tele-Oncology Ltd., Biolidics Ltd., HutchMed, Prenetics, D3 Bio, and Lunit 
      Inc.; holds stock options in, Bowtie Life Insurance Co. Ltd., D3 Bio, Lakeshore 
      Biotech Ltd, Loxo-oncology, Lunit USA, Inc., Virtus Medical Group, Phanes 
      Therapeutics, Inc., and Insighta; served as an advisory board member forAbbVie 
      Inc., ACEA Pharma, Alentis Therapeutics AG, Amgen, AstraZeneca, BerGenBio ASA, 
      Berry Oncology, Blueprint Medicines Corporation, Boehringer Ingelheim, Bowtie 
      Life Insurance Co Ltd, Bristol Myers Squibb, C4 Therapeutics Inc, Covidien LP, 
      CStone Pharmaceuticals, Curio Science, D3 Bio Ltd., Daiichi Sankyo Inc., Eisai, 
      Fishawack Facilitate Ltd., G1 Therapeutics Inc., Gilead Sciences Inc., Gritstone 
      Oncology, Inc., Guardant Health, geneDecode Co. Ltd. (uncompensated), Hengrui 
      Therapeutics Inc., HutchMed, Ignyta Inc., Incyte Corporation, Imagene AI Ltd., 
      Inivata, IQVIA, Janssen, Lakeshore Biotech, Lily, Loxo-Oncology Inc., Lunit, 
      Inc., Merck Serono, MSD, Mirati Therapeutics Inc., MiRXES Group, Novartis, 
      OrigiMed, Pfizer, Prenetics, Puma Biotechnology Inc., Roche/Genentech, Regeneron 
      Pharmaceuticals Inc., Sanofi-Aventis R&D, SFJ Pharmaceutical, Simcere of America 
      Inc., Simcere Zaiming, Inc., Summit Therapeutics, Inc., Takeda, Vertex 
      Pharmaceuticals, Virtus Medical Group, and Yuhan Corporation; served on the board 
      of directors or in a leadership role (renumerated) for AstraZeneca PLC (from 
      January 2019 to present), HutchMed, Aurora, Insighta (from July 2023 to present), 
      and Epoch (from April 2023 to present); and served on the board of directors or 
      in a leadership role (non-renumerated) for American Society of Clinical Oncology 
      (ASCO) (2018-2022), Asian Thoracic Oncology Research Group (ATORG) (2016 to 
      Present), Chinese Lung Cancer Research Foundation Limited (CLCRF) (2005-2012), 
      Chinese Society of Clinical Oncology (CSCO) (2009-2020), Hong Kong Cancer Fund 
      (HKCF) (2011 to Present), Hong Kong Cancer Therapy Society (HKCTS) (2004 to 
      Present), International Association for the Study of Lung Cancer (IASLC) 
      (2007-2019), St. Stephen's College & Prep. School (2017 to Present), and Hong 
      Kong Academy of Sciences (ASHK) (2022 to Present).
EDAT- 2025/12/31 12:55
MHDA- 2026/03/07 16:14
PMCR- 2026/03/06
CRDT- 2025/12/31 06:23
PHST- 2025/08/19 00:00 [revised]
PHST- 2024/11/12 00:00 [received]
PHST- 2025/11/12 00:00 [accepted]
PHST- 2026/03/07 16:14 [medline]
PHST- 2025/12/31 12:55 [pubmed]
PHST- 2025/12/31 06:23 [entrez]
PHST- 2026/03/06 00:00 [pmc-release]
AID - IJC70265 [pii]
AID - 10.1002/ijc.70265 [doi]
PST - ppublish
SO  - Int J Cancer. 2026 May 1;158(9):2429-2439. doi: 10.1002/ijc.70265. Epub 2025 Dec 
      31.
