First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset* |
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| Authors: | Miyako Satouchi Kaname Nosaki Toshiaki Takahashi Kazuhiko Nakagawa Keisuke Aoe Takayasu Kurata Akimasa Sekine Atsushi Horiike Tatsuro Fukuhara Shunichi Sugawara Shigeki Umemura Hideo Saka Isamu Okamoto Nobuyuki Yamamoto Hiroshi Sakai Kazuma Kishi Nobuyuki Katakami Hidehito Horinouchi Toyoaki Hida Hiroaki Okamoto Shinji Atagi Tatsuo Ohira Shi Rong Han Kazuo Noguchi Victoria Ebiana Katsuyuki Hotta |
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| Institution: | 1. Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan;2. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan;3. Division of Thoracic Oncology, Shizuoka Cancer Center, Shuntougun, Japan;4. Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan;5. Department of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center, Ube, Japan;6. Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan;7. Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan;8. Department of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan;9. Miyagi Cancer Center, Natori, Japan;10. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan;11. Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan;12. Department of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan;13. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan;14. Internal Medicine III, Wakayama Medical University, Wakayama, Japan;15. Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan;16. Department of Respiratory Medicine, Respiratory Center, Toranomon Hospital, Tokyo, Japan;17. Division of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe, Japan;18. Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan;19. Department of Thoracic Oncology, Aichi Cancer Center, Aichi, Japan;20. Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen’s Hospital, Yokohama, Japan;21. Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan;22. Department of Surgery, Tokyo Medical University, Tokyo, Japan;23. MSD K.K., Tokyo, Japan;24. Merck & Co., Inc., Kenilworth, NJ, USA;25. Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan |
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| 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 greater 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). The hazard ratio (HR) for progression-free survival by independent central review (data cut-off date, 10 July 2017) was 0.25 (95% confidence interval CI], 0.10-0.64; one-sided, nominal P = .001). The HR for overall survival (data cut-off date, 15 February 2019) was 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 patients (52%) and four 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 greater. The trial is registered with ClinicalTrials.gov: NCT02142738. |
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| Keywords: | Japan non-small-cell lung carcinoma PD-L1 protein pembrolizumab treatment outcome |
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