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

Poster display session

3304 - Pembrolizumab (pembro) as first-line therapy in cisplatin-ineligible advanced urothelial cancer (UC): outcomes from KEYNOTE-052 in senior patients (pts) with poor performance status


10 Sep 2017


Poster display session


Immunotherapy;  Urothelial Cancers


Petros Grivas


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


P. Grivas1, E.R. Plimack2, A.V. Balar3, D. Castellano4, P.H. O'Donnell5, J. Bellmunt6, T. Powles7, N. Hahn8, R. de Wit9, D. Bajorin10, M.C. Ellison11, T. Frenkl11, S.M. Keefe11, J. Vuky12

Author affiliations

  • 1 Department Of Hematology/medical Oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 2 Oncology, Fox Chase Cancer Center, Philadelphia/US
  • 3 Oncology, Perlmutter Cancer Center, NYU Langone Medical Center, New York/US
  • 4 Oncology, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 5 Oncology, The University of Chicago Medical Center, Chicago/US
  • 6 Medicine, Dana-Farber Cancer Institute, Boston/US
  • 7 Centre For Experimental Cancer Medicine, Barts Cancer Institute, London/GB
  • 8 Oncology, Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore/US
  • 9 Oncology, Erasmus MC Cancer Institute, Rotterdam/NL
  • 10 Oncology, Memorial Sloan Kettering Cancer Center, 10022 - New York/US
  • 11 Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 12 Oncology, Oregon Health & Science University, Portland/US


Abstract 3304


Advanced UC is most often seen in senior pts, in whom age-related complications such as renal dysfunction and poor performance status (PS) preclude ∼50% from receiving standard first-line cisplatin treatment. In the phase 2 KEYNOTE-052 trial (NCT02335424), first-line pembro had clinically meaningful antitumor activity (ORR, 24%) and was well tolerated in cisplatin-ineligible pts with UC. Results from the subgroup of pts who were considered senior (≥65 y or ≥ 75 y) and had ECOG PS 2 are presented.


Pts were cisplatin ineligible and had advanced UC, measurable disease (per RECIST v1.1), ECOG PS 0-2, and no prior systemic chemotherapy. Pts received pembro 200 mg Q3W. Radiographic imaging was performed at wk 9, then Q6W for the first year, and Q12W thereafter. The primary end point was ORR (RECIST v1.1, independent radiology review).


Of 370 pts, 302 (82%) were ≥65 y, 179 (48%) were ≥75 y, 120 (32%) were ≥65 y with ECOG PS 2, and 78 (21%) were ≥75 y with ECOG PS 2. Median follow-up was 5 mo. ORR (95% CI) was similar to that reported in the overall study population regardless of age cutoff (Table). Poor PS did not impact ORR in senior pts (Table). 6-mo PFS rates were consistent across senior groups (Table). 64% (≥65 y), 66% (≥75 y), 58% (≥65 and ECOG PS 2), and 64% (≥75 y and ECOG PS 2) of pts experienced treatment-related AEs. 16% of pts ≥65 and ≥75 y and 17% of pts ≥65 and ≥75 y with ECOG PS 2 experienced grade ≥3 treatment-related AEs.Table:

857P Efficacy Outcomes

≥65 y n = 302≥75 y n = 179≥65 y and ECOG PS 2 n = 120≥75 y and ECOG PS 2 n = 78
ORR, % (95% CI)23 (19-28)23 (17-30)24 (17-33)27 (18-38)
CR4 (2-7)2 (1-6)2 (0.2-6)3 (0.3-9)
PR19 (15-24)21 (15-27)22 (15-31)24 (15-35)
6-mo PFS, %30%27%28%27%


Results from subgroup analyses of senior pts with poor PS in KEYNOTE-052 confirm that first-line pembro elicits clinically meaningful responses consistent with the overall study population. Pembro is well tolerated in cisplatin-ineligible pts with UC, including those who are senior with poor PS.

Clinical trial identification

NCT02335424; January 7, 2015

Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.


P. Grivas: Bayer, Merck, AstraZeneca: consult & trial spnsr; Genentech: consult & unbrand progm, trial spnsr; Dendreon, Exelixis, ClovisOncol: consult; Bristol-Myers Squib: consult & unbrand prgrm; Genmab: Grant; Mirati, Oncogenex, Pfizer: to Cleve Clin Found for clin trial. E. Plimack: Ad Board: AstraZeneca, Bristol-Myers Squib, Eli Lilly and Company, Exelexis, Genentech, Horizon Pharma, Inovio, Novartis, Pfizer, Roche; Grant/Trials: Acceleron, Agensys, AstraZeneca, Bristol-Myers Squib, Merck, Peloton, Pfizer. Patent: U.S. Patent Application No.: 14/588,503, Filed 1/2/2015. A.V. Balar: Merck, Roche/Genentech: Research Support, Consulting/Advisory Role, Honoraria. AstraZeneca/Medimmune, Pfizer/EMD Serono: Consulting/Advisory Role. D. Castellano: Advisory board member: Ipsen, Roche, Pfizer; Speakers’ bureau: Pfizer, Astellas, Janssen; Honoraria: Pfizer, Novartis and Bayer. P.H. O\'Donnell: Honorarium: Genentech/Roche, Novartis, Merck, AstraZeneca, Astellas Pharma, Seattle Genetics, Inovio, Parexel. Institutional research funding: Boehringer Ingelheim, Merck, Genentech/Roche, AstraZeneca/Medimmune, Acerta Pharma, Janssen. J. Bellmunt: Merck: Educational lectures and adboards, Genentech: Lectures and adboards, Pfizer: Adboard, AstraZeneca: Lectures and adboard. T. Powles: Research funding: Merck, AstraZeneca, Roche Honoraria: Pfizer, Merck, AstraZeneca, Roche, Novartis Travel expenses, including accommodations: Pfizer, Merck, AstraZeneca, Roche, Novartis N. Hahn: Grant Res: Novartis, OncoGenex, Mirati, Merck, Genentech, Bristol-Myers Squib, Heat Biologics, Acerta, AstraZeneca, Principia Bioph, Seattle Genetics. Consult: Merck, Genentech, Inovio, Bristol-Myers Squib, AstraZeneca, Pieris Pharma, TARIS Biomedical, Champions Oncology, Health Advances. R. de Wit: Ad Board: Merck, Roche, Sanofi, Lilly. D. Bajorin: Advisory board member: Roche, Merck, Genentech, Pfizer, AstraZeneca; Research funding: Merck, Genentech, Bristol-Myers Squib, Roche, Novartis; Honoraria: Merck, Genentech Travel expenses, including accommodations: Merck, Genentech, Bristol-Myers Squib, Roche, Novartis. M.C. Ellison, T. Frenkl: Employment: Merck & Co. S.M. Keefe: Employment: Merck & Co., Inc. travel expenses, including accommodations: Merck & Co., Inc. J. Vuky: Advisory board member: Pfizer; Research funding: Pfizer, Merck, Roche, Celldex.

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.