Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Genitourinary tumours, non-prostate

3789 - Subgroup Analyses from KEYNOTE-045: Pembrolizumab (pembro) Versus Individual Investigator’s Choice of Chemotherapy (paclitaxel, docetaxel, or vinflunine) in Recurrent, Advanced Urothelial Cancer (UC)


10 Sep 2017


Genitourinary tumours, non-prostate


Immunotherapy;  Urothelial Cancers


Daniel Petrylak


Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371


D. Petrylak1, N.J. Vogelzang2, Y. Fradet3, D. Bajorin4, R. de Wit5, D.J. Vaughn6, J. Lee7, L. Fong8, M.A. Climent9, A. Necchi10, W.R. Gerritsen11, H. Gurney12, D.I. Quinn13, S. Culine14, C.N. Sternberg15, E. Jensen16, M. Puhlmann16, R.F. Perini16, J. Bellmunt17, T.K. Choueiri18

Author affiliations

  • 1 Medical Oncology, Yale University School of Medicine Medical Oncology, 06520-8032 - New Haven/US
  • 2 Medical Oncology, Comprehensive Cancer Centers of Nevada, 89169 - Las Vegas/US
  • 3 Medical Oncology, CHU de Québec-Université Laval, Quebec City/CA
  • 4 Medical Oncology, Memorial Sloan Kettering Cancer Center, 10022 - New York/US
  • 5 Oncology, Erasmus MC Cancer Institute, Rotterdam/NL
  • 6 Medical Oncology, Abramson Cancer Center of the University of Pennsylvania, Philadelphia/US
  • 7 Oncology, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 8 Medical Oncology, University of California, 94143 - San Francisco/US
  • 9 Medical Oncology, Fundación Instituto Valenciano de Oncología, Valencia/ES
  • 10 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 11 Medical Oncology, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 12 Medical Oncology, Westmead Hospital and Macquarie University, Sydney/AU
  • 13 Medical Oncology, University of Southern California Norris Comprehensive Cancer Center and Hospital, 90033 - los angeles/US
  • 14 Medical Oncology, Hôpital St. Louis, 75010 - Paris/FR
  • 15 Department Of Oncology, San Camillo and Forlanini Hospitals, 156 - Rome/IT
  • 16 Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 17 Medical Oncology, Dana-Farber Cancer Institute, 2215 - Boston/US
  • 18 Medical Oncology, Dana-Farber Cancer Institute, Boston/US


Abstract 3789


In the open-label, phase 3 KEYNOTE-045 study (NCT02256436), overall survival (OS) was significantly longer with pembro vs investigator’s choice of chemo (median, 10.3 vs 7.4 mo; hazard ratio [HR], 0.73; P = 0.002) in recurrent, advanced UC. In a post hoc analysis, pembro was compared with the individual agents in the chemo arm.


Pts with histologically or cytologically confirmed UC, progression after platinum, ECOG PS 0-2, measurable disease (RECIST v1.1), and ≤2 lines of systemic therapy were randomly assigned 1:1 to pembro 200 mg Q3W or investigator’s choice of paclitaxel 175 mg/m2 Q3W, docetaxel 75 mg/m2 Q3W, or vinflunine 320 mg/m2 Q3W. Primary end points: OS and PFS (RECIST v1.1, blinded central review). ORR (RECIST v1.1, blinded central review) was a secondary end point.


525 pts were included in these analyses (allocation: pembro, 270; paclitaxel, 84; docetaxel, 84; vinflunine, 87). Baseline demographics were generally balanced among the 4 groups. Median follow-up was 14 mo (range, 10-22 mo). Pembro was associated with an OS benefit over the individual chemo agents (HR [95% CI]: paclitaxel, 0.77 [0.57-1.06]; docetaxel, 0.78 [0.56-1.08]; vinflunine, 0.71 [0.52-0.96]). PFS was similar between pembro and each of the chemo agents. ORR (95% CI) was 21% (16%-27%) with pembro vs 12% (6%-21%), 6% (2%-13%), and 18% (11%-28%) with paclitaxel, docetaxel, and vinflunine, respectively. Treatment-related AEs occurred in 61% (pembro), 88% (paclitaxel), 92% (docetaxel), and 91% (vinflunine) of pts. 15% (pembro), 44% (paclitaxel), 54% (docetaxel), and 51% (vinflunine) experienced treatment-related AEs of grade ≥3 severity.


Results from subgroup analyses of KEYNOTE-045 demonstrate that pembro was associated with longer OS, higher antitumor activity, and lower incidence of toxicities than single-agent paclitaxel, docetaxel, or vinflunine in pts with advanced UC that progressed on/after platinum-based therapy. Pembro is the first agent to demonstrate OS improvement vs chemo in this setting and should be considered for use in recurrent, advanced UC.

Clinical trial identification

NCT02256436; September 29, 2014

Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.


D. Petrylak: Ad board member: Bayer, Bellicum, Dendreon, Sanofi, J&J, Exelixis, Ferring, Millineum, Medivation, Pfizer, Roche, Tyme; Funding: Oncogenix, Progenics, J&J, Merck, Millineum, Dendreon, Sanofi, Agensys, Lilly, Roche; Stocks: Bellicum, Tyme. N.J. Vogelzang: Speaker: Medivation, Dendreon, Bayer, Caris MPI, Millennium, Sanofi, GSK, Pfizer, Genentech, Bristol-Myers Squib; Funding: PAREXEL; Progenics, Exelixis; US Oncology; Viamet; Endocyte; GSK; Merck Y. Fradet: Ad board member: Merck, Astellas, Roche, AstraZeneca; Funding: Astellas; Travel expenses: Roche. D. Bajorin: Honoraria: Merck, Genentech; Ad board: Roche, Merck, Genentech, Pfizer, AstraZeneca; Funding: Merck, Genentech, Bristol-Myers Squib, Roche, Novartis; R. de Wit: Ad board member: Merck, Roche, Sanofi, Lilly. D.J. Vaughn: Consultant: Astellas Pharma. J-L. Lee: Ad board: Astellas, AstraZeneca; Eisai; Honoraria: Pfizer, Astellas Pharma, Novartis; Funding: Pfizer, Janssen, Novartis, Exelixis. L. Fong: Funding: Dendreon, Bristol-Myers Squib, Oncosec, Abbvie, Genentech, Janssen. M.A. Climent: Honoraria: Roche, Bristol-Myers Squib, Bayer, Astellas, Sanofi, Janssen, Pfizer, Novartis; Ad board: Janseen, Pfizer, Roche, Sanofi, Astellas, Bayer; Travel expenses: Astellas, Janssen, Pfizer. W.R. Gerritsen: Ad board member: Bristol-Myers Squib, Amgen, MSD, Aglaia Biomedical Ventures, Astellas, Bayer, Janssen; Speaker: MSD, Bristol-Myers Squib; Funding: Astellas, Bayer, Janssen; Travel expenses: Amgen, Bayer. H. Gurney: Ad board: Bristol-Myers Squib, GSK, Pfizer, Astellas; Travel expenses: Astellas. D.I. Quinn: Ad board: Pfizer, Bristol-Myers Squib, Merck, EMD Serono, AstraZeneca, Genentech, Exelixis; Funding: Pfizer, Merck; Honoraria: Pfizer, Bristol-Myers Squib, Merck, EMD Serono, AstraZeneca, Genentech, Exelixis. S. Culine: Ad board: Roche, Janssen; Funding: Astellas, Roche, MSD; Travel expenses: Amgen, Astellas, Janssen. C.N. Sternberg: Honoraria: Pfizer, Bristol-Myers Squib, Novartis, Janssen, Bayer, Astellas Pharma, Sanofi, Eisai, Ipsen, GSK, MSD. E. Jensen: Employee of Merck & Co., Inc. M. Puhlmann, R. Perini: Employee of Merck & Co., Inc. J. Bellmunt: Personal fees: Merck, Genentech, Pfizer, AstraZeneca. T.K. Choueiri: Ad board: AstraZeneca, Bayer, Bristol-Myers Squib, Cerulean, Eisai, Foundation Medicine, Genetech, GSK, Merck, Novartis, Peloton, Pfizer, Prometheus, Roche, Eisai; Funding: AstraZeneca, Bristol-Myers Squib, Exelixis, Genentech, GSK, Merck, Novartis, Peloton, Pfizer, Roche, Tracon, Eisai. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.