Pembrolizumab (Keytruda) for unresectable or metastatic bladder cancer

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Regimen in use at


Study Evidence Efficacy Pt Population Comparator Efficacy
Bellmunt et al. 2017 (KEYNOTE-045) Phase III 21% second-line therapy Paclitaxel
Superior OS
Balar et al. 2016 (KEYNOTE-052) Phase II 28.6% (95% CI 24 to 34%) first-line therapy none


21-day cycles


  1. Abstract: A. Balar, J. Bellmunt, P.H. O'Donnell, D. Castellano, P. Grivas, J. Vuky, T. Powles, E.R. Plimack, N.M. Hahn, R. de Wit, L. Pang, M.J. Savage, R. Perini, S. Keefe, D. Bajorin. Pembrolizumab (pembro) as first-line therapy for advanced/unresectable or metastatic urothelial cancer: Preliminary results from the phase 2 KEYNOTE-052 study. Ann Oncol (2016) 27 (suppl_6): LBA32_PR. link to abstract
  2. Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Poehlein CH, Perini RF, Bajorin DF; KEYNOTE-045 Investigators. Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med. 2017 Mar 16;376(11):1015-1026. Epub 2017 Feb 17. link to original article contains verified protocol PubMed