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’s 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