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Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial.
Verset, Gontran; Borbath, Ivan; Karwal, Mark; Verslype, Chris; Van Vlierberghe, Hans; Kardosh, Adel; Zagonel, Vittorina; Stal, Per; Sarker, Debashis; Palmer, Daniel H; Vogel, Arndt; Edeline, Julien; Cattan, Stephane; Kudo, Masatoshi; Cheng, Ann-Lii; Ogasawara, Sadahisa; Daniele, Bruno; Chan, Stephen L; Knox, Jennifer J; Qin, Shukui; Siegel, Abby B; Chisamore, Michael; Hatogai, Ken; Wang, Anran; Finn, Richard S; Zhu, Andrew X.
Afiliación
  • Verset G; Gastrointestinal Oncology Unit, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
  • Borbath I; Cliniques Universitaires Saint-Luc and Université Catholique de Louvain, Brussels, Belgium.
  • Karwal M; University of Iowa, Iowa City, Iowa.
  • Verslype C; Digestive Oncology, Department of Oncology, University Hospital Leuven, Belgium.
  • Van Vlierberghe H; Ghent University, Ghent, Belgium.
  • Kardosh A; Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon.
  • Zagonel V; Oncology Unit 1, Istituto Oncologico Veneto, IOV, IRCCS, Padua, Italy.
  • Stal P; Karolinska Institutet, Stockholm, Sweden.
  • Sarker D; School of Cancer and Pharmaceutical Sciences, King's College London, London, United Kingdom.
  • Palmer DH; Cancer Research UK Liverpool Experimental Cancer Medicine Centre, University of Liverpool, Liverpool, United Kingdom.
  • Vogel A; Department of Gastroenterology, Hepatology, and Endocrinology, Medizinische Hochschule, Hannover, Germany.
  • Edeline J; Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.
  • Cattan S; Department of Medical Oncology and Gastroenterology, Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire de Lille, Lille, France.
  • Kudo M; Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
  • Cheng AL; Department of Medical Oncology, National Taiwan University Cancer Center, and Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
  • Ogasawara S; Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.
  • Daniele B; Oncology Unit, Ospedale del Mare, Napoli, Italy.
  • Chan SL; Department of Clinical Oncology, State Key Laboratory of Translational Oncology, The Chinese University of Hong Kong, Shatin, Hong Kong.
  • Knox JJ; Department of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
  • Qin S; Cancer Centre of Jinling Hospital, Nanjing University of Chinese Medicine, Nanjing, China.
  • Siegel AB; Merck & Co., Inc., Kenilworth, New Jersey.
  • Chisamore M; Merck & Co., Inc., Kenilworth, New Jersey.
  • Hatogai K; Merck & Co., Inc., Kenilworth, New Jersey.
  • Wang A; Merck & Co., Inc., Kenilworth, New Jersey.
  • Finn RS; Department of Medicine, University of California, Los Angeles, California.
  • Zhu AX; Massachusetts General Hospital Cancer Center and Department of Medicine, Harvard Medical School, Boston, Massachusetts.
Clin Cancer Res ; 28(12): 2547-2554, 2022 06 13.
Article en En | MEDLINE | ID: mdl-35421228
PURPOSE: KEYNOTE-224 cohort 1 demonstrated that pembrolizumab was efficacious and tolerable in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. We report results from KEYNOTE-224 (NCT02702414) cohort 2, which enrolled patients with advanced HCC and no prior systemic therapy. PATIENTS AND METHODS: KEYNOTE-224 was an open-label, multicountry phase II trial. Eligible patients in cohort 2 had advanced HCC not amenable or refractory to locoregional therapy and not previously treated with systemic therapy. Patients received pembrolizumab 200 mg intravenously every 3 weeks for ≤2 years. Primary endpoint was objective response rate (ORR) by central imaging review per RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety/tolerability. RESULTS: Between September 4, 2018, and February 20, 2019, 51 patients were allocated in cohort 2. The median time from the first dose to data cutoff (January 19, 2021) was 27 months (range, 23-29). ORR was 16% [95% confidence interval (CI), 7-29] and was similar across key subgroups. Median DOR was 16 months (range, 3-24+), and DCR was 57%. The median PFS was 4 months (95% CI, 2-8), and median TTP was 4 months (95% CI, 3-9). Median OS was 17 months (95% CI, 8-23). Grade ≥3 treatment-related adverse events occurred in 16% of patients. CONCLUSIONS: In patients with advanced HCC with no prior systemic therapy, pembrolizumab provided durable antitumor activity, promising OS, and had a safety profile consistent with previous observations. These findings support further evaluation of pembrolizumab-based regimens for HCC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma Hepatocelular / Anticuerpos Monoclonales Humanizados / Neoplasias Hepáticas Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma Hepatocelular / Anticuerpos Monoclonales Humanizados / Neoplasias Hepáticas Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Estados Unidos