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Genitourinary tumours, non-prostate

2626 - Pembrolizumab (pembro) as first-line therapy for advanced/unresectable or metastatic urothelial cancer: Preliminary results from the phase 2 KEYNOTE-052 study


08 Oct 2016


Genitourinary tumours, non-prostate


Arjun Balar


Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435


A. Balar1, J. Bellmunt2, P.H. O'Donnell3, D. Castellano4, P. Grivas5, J. Vuky6, T. Powles7, E.R. Plimack8, N.M. Hahn9, R. de Wit10, L. Pang11, M.J. Savage12, R. Perini13, S. Keefe14, D. Bajorin15

Author affiliations

  • 1 Medical Oncology, Perlmutter Cancer Center, NYU Langone Medical Center, 10016 - New York/US
  • 2 Medical Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 3 Dept. Of Medicine, The University of Chicago Medical Centre, 60637-1470 - Chicago/US
  • 4 Medical Oncology, Hospital Universitario 12 de Octubre, Madrid/ES
  • 5 Hematology/oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 6 Hematology And Oncology, Oregon Health Sciences University, Portland/US
  • 7 Genitourinary Oncology, Barts Cancer Institute, Queen Mary University of London, London/GB
  • 8 Department Of Hematology/oncology, Fox Chase Cancer Center, PA 19111-2497 - Philadelphia/US
  • 9 Oncology And Urology, Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore/US
  • 10 Medical Oncology, Erasmus MC Cancer Institute, 3075EA - Rotterdam/NL
  • 11 Bards Late Development Statistics, Merck & Co., Inc., Kenilworth/US
  • 12 Companion Diagnostics, Merck & Co., Inc., Kenilworth/US
  • 13 Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 14 Clinical Research & Development, Merck & Co., Inc., Kenilworth/US
  • 15 Medicine, Memorial Sloan Kettering Cancer Center, New York/US


Abstract 2626


KEYNOTE-052 (NCT02335424), an open-label, multicenter, phase 2 study, evaluated the efficacy and safety of pembro in first-line cisplatin-ineligible pts with u/m UC.


374 pts have been enrolled. Eligibility included pathologically confirmed and measurable u/m UC, age ≥18 y, no chemotherapy for u/m disease, ECOG PS 0-2, and cisplatin ineligibility (ECOG PS 2, creatinine clearance


Median age was 75 years (13% ≥85). 13% received perioperative chemotherapy. 87% had visceral disease. 46% were ECOG 2/3. 45% were cisplatin ineligible because of renal insufficiency only. 11% were cisplatin ineligible because of ECOG 2 performance status and renal insufficiency. The CPS-high cutpoint was determined to be ≥10% PD-L1 expression. As of 6/1/16, data cutoff (median 8 mo follow-up), ORR was as follows:

% (95% CI) All subjects N = 100 CPS ≥1% N = 63 CPS ≥10% N = 30
ORR 24.0 (16.0-33.6) 25.4 (15.3-37.9) 36.7 (19.9-56.1)
CR 6.0 (2.2-12.6) 6.3 (1.8-15.5) 13.3 (3.8-30.7)
Median duration of response (DOR) has not been reached (range, 1.4+ - 9.8+ mo). DOR rate ≥6 months was 83% (Kaplan-Meier estimate). 67% of pts experienced a drug-related adverse event (DRAE), most commonly fatigue (14%). 16% experienced a grade 3/4 DRAE. 5% discontinued therapy because of a DRAE.


Pembro 200 mg Q3W demonstrates substantial antitumor activity and has a manageable toxicity profile in cisplatin-ineligible pts with u/m UC. CPS high cutpoint was determined to be ≥10% PD-L1 expression. CR rate of 6% for all pts and 13.3% for pts CPS ≥10% is encouraging.

Clinical trial identification


Legal entity responsible for the study

Merck & Co. Inc.


Merck & Co., Inc.


J. Bellmunt: Advisory board member for Merck, Genentech, Pfizer, Novartis, Sanofi, and Pierre Fabre, and research grants from Takeda, Novartis, and Sanofi. P.H. O'Donnell: Advisory board member for Genentech, Astra Zeneca/Medimmune, and Merck, and research grants from Genentech, Merck, and Astra Zeneca/Medimmune. P. Grivas: Advisory board member for Merck, Genentech, Bristol-Myers Squibb, Bayer, and Dendreon, and research grants from Merck, Genentech, Oncogenex, Bayer, Mirati, and Pfizer. T. Powles: Honoraria from GlaxoSmithKline, Roche, Merck, and Bristol-Myers Squibb, and research grants from Roche/Genentech. E.R. Plimack: Advisory board member for Acceleron, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, Eli Lilly Inc., Novartis, Pfizer, and Synergene, and research grants from Acceleron, AstraZeneca, Bristol-Myers Squibb, Eli Lilly Inc., Merck, and Pfizer. N.M. Hahn: Advisory board member for AZ/MedImmune, Inovio, Pieris, Genentech/Roche, Merck, BMS, and OncoGeneX, and research grants to my institution from Novartis, BMS, Heat Biologics, Merck, Genentech/Roche, AZ/MedImmune, Principia Biopharma, Mirati, and OncoGeneX. R. de Wit: Advisory board member for Sanofi, Merck, Lilly, and Roche, and research grants from Sanofi. L. Pang, R. Perini: Employee of and own stock in Merck & Co., Inc. M.J. Savage: Employee of and may own stock in Merck & Co., Inc. S. Keefe: Employee of Merck & Co., Inc. D. Bajorin: Advisory board member for Bristol-Myers Squibb, Roche, Merck, Genentech, Pfizer, and Novartis, and research grants from Roche, Merck, and Novartis. All other authors have declared no conflicts of interest.

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