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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

3762 - KEYNOTE-427 Cohort A: Pembrolizumab Monotherapy as First-Line Therapy in Advanced Clear Cell Renal Cell Carcinoma (ccRCC)


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care



Tumour Site

Renal Cell Cancer


Frede Donskov


Annals of Oncology (2018) 29 (suppl_8): viii303-viii331. 10.1093/annonc/mdy283


F. Donskov1, D.F. McDermott2, J.L. Lee3, C. Szczylik4, J. Malik5, B.Y. Alekseev6, J.M..G. Larkin7, V.B. Matveev8, R. Airatovich Gafanov9, P. Tomczak10, S.S. Tykodi11, P.F. Geertsen12, P. Wiechno13, S.J. Shin14, F. Pouliot15, T. Alonso Gordoa16, R. Kloss Silverman17, R.F. Perini17, C. Schloss17, M.B. Atkins18

Author affiliations

  • 1 Department Of Oncology, Aarhus University Hospital, 8000 - Aarhus/DK
  • 2 Medical Oncology, Beth Israel Deaconess Medical Center, 2215 - Boston/US
  • 3 Medical Oncology, Asan Medical Center and University of Ulsan College of Medicine, Seoul/KR
  • 4 Medical Oncology, Wojskowy Instytut Medyczny, Warsaw/PL
  • 5 Medical Oncology, Edinburgh Cancer Centre, Western General Hospital, Edinburgh/GB
  • 6 Oncourology, P. A. Herzen Moscow Oncology Research Institute, Ministry of Health of the Russian Federation, 125284 - Moscow/RU
  • 7 Medicine, Institute of Cancer Research, London/GB
  • 8 Medical Oncology, N.N. Blokhin Russian Cancer Research Center, Moscow/RU
  • 9 Urology, Russian Scientific Center of Roentgenoradiology, Moscow/RU
  • 10 Medical Oncology, Clinical Hospital No. 1 of the Poznan University of Medical Sciences, Poznan/PL
  • 11 Department Of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, 98109 - Seattle/US
  • 12 Medical Oncology, Herlev Hospital, University of Copenhagen, Herlev/DK
  • 13 Medical Oncology, Maria Sklodowska-Curie Memorial Cancer Center, Warsaw/PL
  • 14 Internal Medicine, Yonsei University College of Medicine, Seoul/KR
  • 15 Surgery, Université Laval, Quebec/CA
  • 16 Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 17 Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 18 Medical Oncology, Georgetown Lombardi Comprehensive Cancer Center, Washington/US


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Abstract 3762


KEYNOTE-427 (NCT02853344) is a single-arm, open-label, 2-cohort, phase 2 study to evaluate efficacy and safety of the PD-1 inhibitor pembrolizumab (pembro) as first-line monotherapy in advanced ccRCC and non-ccRCC. Results from the ccRCC cohort (cohort A) are presented.


Pembro 200 mg was administered intravenously Q3W for 2 y or until confirmed progressive disease, unacceptable toxicity, or patient (pt) decision to withdraw. Pts with histologically confirmed advanced ccRCC who had received no prior systemic therapy were eligible. Additional key eligibility criteria: measurable disease (RECIST v1.1, independent central review [ICR]) and Karnofsky performance status ≥70%. Primary end point: ORR per RECIST v1.1, by ICR. Additional end points: DOR, PFS, OS, safety, and biomarkers associated with response.


At data cutoff (Oct 6, 2017), median (range) follow-up was 7.2 (0.9-11.7) mo. 110 pts enrolled; 107 were included in efficacy analysis (opportunity for ≥1 postbaseline assessment). Treatment was ongoing for 64 (58.2%) pts. Median age (range) was 64 (29-87) years; 78% were male. 37.3%, 47.3%, and 15.5% had IMDC risk categories of favorable, intermediate, and poor, respectively. Confirmed ORR by ICR was 33.6% (n = 36; 95% CI 24.8-43.4) with 1 complete response (0.9%) and 35 (32.7%) partial responses. 39 (36.4%) had stable disease. ORR for pts with favorable or intermediate/poor risk IMDC was 27.5% and 37.3%, respectively. Median DOR was not reached (range 1.4+ to 8.2+ mo); 86.1% of responders had response ≥3 months. Median PFS was 6.9 (95% CI 5.1-NR) mo; PFS rate at 6 mo was 53.6%. OS rates at 3 and 6 mo were 97.2% and 92.4%, respectively. 73.6% of pts had a treatment-related adverse event (AE); most common (≥10%) were fatigue (23.6%), pruritus (21.8%), diarrhea (16.4%), rash (12.7%), and arthralgia (11.8%). 18.2% experienced a grade 3-5 treatment-related AE; 1 pt had grade 5 pneumonitis.


Pembro monotherapy showed encouraging efficacy and acceptable tolerability in pts with advanced ccRCC. Updated analyses will be presented using additional follow-up data and outcomes by PDL-1 status and other relevant subgroups.

Clinical trial identification

NCT02853344. Trial initiated August 2, 2016.

Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.

Editorial Acknowledgement

Medical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck & Co., Inc., Kenilworth, NJ, USA.


F. Donskov: Research funding: Pfizer, Novartis, Ipsen. B.Y. Alekseev: Research funding: Merck. J.M.G. Larkin: Research funding: BMS, MSD, Novartis, Pfizer; Honoraria: BMS, MSD, GSK, Pfizer, Novartis, EUSA pharma, Roche/Genentech, Secarna, Pierre Fabre, Eisai, Kymab; Travel expenses, including accommodations: BMS, MSD, GSK, Pfizer, Novartis, EUSA Pharma, Roche/Genentech, Secarna, Pierre Fabre, Eisai, Kymab; Consultancy: BMS, MSD, GSK, Pfizer, Novartis, EUSA Pharma, Roche/Genentech, Secarna, Pierre Fabre, Eisai, Kymab. S.S. Tykodi: Advisory board: Calithera Biosciences, Prometheus Laboratories; Research funding (to institution): Merck, Bristol-Myers Squibb, Peloton Therapeutics, Nektar Therapeutics, Calithera Biosciences, Jounce Therapeutics, Pfizer, Genentech, Prometheus Laboratories, Argos Therapeutics. P.F. Geertsen: Research funding: Novartis; Travel expenses: Novartis, BMS, Pfizer. T. Alonso Gordoa: Research funding: Roche; Honoraria: Pfizer, Janssen, Astellas, Novartis, Roche, Sanofi. R. Kloss Silverman, R.F. Perini: Employment: Merck & Co., Inc. C. Schloss: Employment and stock ownership: Merck & Co., Inc. M.B. Atkins: Consulting: BMS, Merck, Novartis, Genentech/Roche, Pfizer, Exelixis, Eisai, AstraZeneca, Array; Research funding: BMS, Novartis, Genentech/Roche; Board of directors or advisory committees: Novartis, Merck, Pfizer. All other authors have declared no conflicts of interest.

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