start-ver=1.4 cd-journal=joma no-vol=111 cd-vols= no-issue=12 article-no= start-page=4480 end-page=4489 dt-received= dt-revised= dt-accepted= dt-pub-year=2020 dt-pub=20200914 dt-online= en-article= kn-article= en-subject= kn-subject= en-title= kn-title=First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset en-subtitle= kn-subtitle= en-abstract= kn-abstract=This prespecified subanalysis of the global, randomized controlled phase III KEYNOTE]024 study of pembrolizumab vs chemotherapy in previously untreated metastatic non]small]cell lung cancer without EGFR/ALK alterations and a programmed death ligand 1 (PD]L1) tumor proportion score of 50% or higher evaluated clinical outcomes among patients enrolled in Japan. Treatment consisted of pembrolizumab 200 mg every 3 weeks (35 cycles) or platinum]based chemotherapy (four to six cycles). The primary end]point was progression]free survival; secondary end]points included overall survival and safety. Of 305 patients randomized in KEYNOTE]024 overall, 40 patients were enrolled in Japan (all received treatment: pembrolizumab, n = 21; chemotherapy, n = 19). Median progression]free survival was 41.4 (95% confidence interval [CI], 4.2]42.5) months with pembrolizumab and 4.1 (95% CI, 2.8]8.3) months with chemotherapy (hazard ratio [HR], 0.27 [95% CI, 0.11]0.65]; one]sided, nominal P = .001). Median overall survival was not reached (NR) (95% CI, 22.9?NR) and 21.5 (95% CI, 5.2]35.0) months, respectively (HR, 0.39 [95% CI, 0.17]0.91]; one]sided, nominal P = .012). Treatment]related adverse events occurred in 21/21 (100%) pembrolizumab]treated and 18/19 (95%) chemotherapy]treated patients; eight patients (38%) and nine patients (47%), respectively, had grade 3]5 events. Immune]mediated adverse events and infusion reactions occurred in 11 pembrolizumab]treated patients (52%) and four chemotherapy]treated patients (21%), respectively; four patients (19%) and one patient (5%), respectively, had grade 3]5 events. Consistent with results from KEYNOTE]024 overall, first]line pembrolizumab improved progression]free survival and overall survival vs chemotherapy with manageable safety among Japanese patients with metastatic non]small]cell lung cancer without EGFR/ALK alterations and a PD]L1 tumor proportion score of 50% or higher. The trial is registered with Clinicaltrials.gov: NCT02142738. en-copyright= kn-copyright= en-aut-name=SatouchiMiyako en-aut-sei=Satouchi en-aut-mei=Miyako kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=1 ORCID= en-aut-name=NosakiKaname en-aut-sei=Nosaki en-aut-mei=Kaname kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=2 ORCID= en-aut-name=TakahashiToshiaki en-aut-sei=Takahashi en-aut-mei=Toshiaki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=3 ORCID= en-aut-name=NakagawaKazuhiko en-aut-sei=Nakagawa en-aut-mei=Kazuhiko kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=4 ORCID= en-aut-name=AoeKeisuke en-aut-sei=Aoe en-aut-mei=Keisuke kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=5 ORCID= en-aut-name=KurataTakayasu en-aut-sei=Kurata en-aut-mei=Takayasu kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=6 ORCID= en-aut-name=SekineAkimasa en-aut-sei=Sekine en-aut-mei=Akimasa kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=7 ORCID= en-aut-name=HoriikeAtsushi en-aut-sei=Horiike en-aut-mei=Atsushi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=8 ORCID= en-aut-name=FukuharaTatsuro en-aut-sei=Fukuhara en-aut-mei=Tatsuro kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=9 ORCID= en-aut-name=SugawaraShunichi en-aut-sei=Sugawara en-aut-mei=Shunichi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=10 ORCID= en-aut-name=UmemuraShigeki en-aut-sei=Umemura en-aut-mei=Shigeki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=11 ORCID= en-aut-name=SakaHideo en-aut-sei=Saka en-aut-mei=Hideo kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=12 ORCID= en-aut-name=OkamotoIsamu en-aut-sei=Okamoto en-aut-mei=Isamu kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=13 ORCID= en-aut-name=YamamotoNobuyuki en-aut-sei=Yamamoto en-aut-mei=Nobuyuki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=14 ORCID= en-aut-name=SakaiHiroshi en-aut-sei=Sakai en-aut-mei=Hiroshi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=15 ORCID= en-aut-name=KishiKazuma en-aut-sei=Kishi en-aut-mei=Kazuma kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=16 ORCID= en-aut-name=KatakamiNobuyuki en-aut-sei=Katakami en-aut-mei=Nobuyuki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=17 ORCID= en-aut-name=HorinouchiHidehito en-aut-sei=Horinouchi en-aut-mei=Hidehito kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=18 ORCID= en-aut-name=HidaToyoaki en-aut-sei=Hida en-aut-mei=Toyoaki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=19 ORCID= en-aut-name=OkamotoHiroaki en-aut-sei=Okamoto en-aut-mei=Hiroaki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=20 ORCID= en-aut-name=AtagiShinji en-aut-sei=Atagi en-aut-mei=Shinji kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=21 ORCID= en-aut-name=OhiraTatsuo en-aut-sei=Ohira en-aut-mei=Tatsuo kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=22 ORCID= en-aut-name=HanShi Rong en-aut-sei=Han en-aut-mei=Shi Rong kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=23 ORCID= en-aut-name=NoguchiKazuo en-aut-sei=Noguchi en-aut-mei=Kazuo kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=24 ORCID= en-aut-name=EbianaVictoria en-aut-sei=Ebiana en-aut-mei=Victoria kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=25 ORCID= en-aut-name=HottaKatsuyuki en-aut-sei=Hotta en-aut-mei=Katsuyuki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=26 ORCID= affil-num=1 en-affil=Department of Thoracic Oncology, Hyogo Cancer Center kn-affil= affil-num=2 en-affil=Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center kn-affil= affil-num=3 en-affil=Division of Thoracic Oncology, Shizuoka Cancer Center kn-affil= affil-num=4 en-affil=Department of Medical Oncology, Kindai University Faculty of Medicine kn-affil= affil-num=5 en-affil=Department of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center kn-affil= affil-num=6 en-affil=Department of Thoracic Oncology, Kansai Medical University kn-affil= affil-num=7 en-affil=Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center kn-affil= affil-num=8 en-affil=Department of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research kn-affil= affil-num=9 en-affil=Department of Respiratory Medicine, Miyagi Cancer Center kn-affil= affil-num=10 en-affil=Department of Pulmonary Medicine, Sendai Kousei Hospital kn-affil= affil-num=11 en-affil=Department of Thoracic Oncology, National Cancer Center Hospital East kn-affil= affil-num=12 en-affil=Department of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center kn-affil= affil-num=13 en-affil=Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University kn-affil= affil-num=14 en-affil=Internal Medicine III, Wakayama Medical University kn-affil= affil-num=15 en-affil=Department of Thoracic Oncology, Saitama Cancer Center kn-affil= affil-num=16 en-affil=Department of Respiratory Medicine, Respiratory Center, Totanomon Hospital kn-affil= affil-num=17 en-affil=Division of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital kn-affil= affil-num=18 en-affil=Department of Thoracic Oncology, National Cancer Center Hospital kn-affil= affil-num=19 en-affil=Department of Thoracic Oncology, Aichi Cancer Center kn-affil= affil-num=20 en-affil=Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizenfs Hospital kn-affil= affil-num=21 en-affil=Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center kn-affil= affil-num=22 en-affil=Department of Surgery, Tokyo Medical University kn-affil= affil-num=23 en-affil=MSD, K.K. kn-affil= affil-num=24 en-affil=MSD, K.K. kn-affil= affil-num=25 en-affil=Merck & Co., Inc. kn-affil= affil-num=26 en-affil=Center for Innovative Clinical Medicine, Okayama University Hospital kn-affil= en-keyword=Japan kn-keyword=Japan en-keyword=non-small-cell lung carcinoma kn-keyword=non-small-cell lung carcinoma en-keyword=PD-L1 protein kn-keyword=PD-L1 protein en-keyword=pembrolizumab kn-keyword=pembrolizumab en-keyword=treatment outcome kn-keyword=treatment outcome END