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Poster Discussion session - Gynaecological cancers

4294 - Association of PD-L1 Expression and Gene Expression Profiling With Clinical Response to Pembrolizumab in Patients With Advanced Recurrent Ovarian Cancer: Results From the Phase 2 KEYNOTE-100 Study


20 Oct 2018


Poster Discussion session - Gynaecological cancers


Immunotherapy;  Translational Research

Tumour Site

Ovarian Cancer


Jonathan Ledermann


J.A. Ledermann1, R. Shapira-Frommer2, A. Santin3, A.S. Lisyanskaya4, S. Pignata5, I. Vergote6, F. Raspagliesi7, G.S. Sonke8, M.J. Birrer9, D.M. Provencher10, J. Sehouli11, N. Colombo12, A. González-Martín13, A. Oaknin14, P.B. Ottevanger15, V. Rudaitis16, R. Cristescu17, J. Kobie17, J. Ruman17, U.A. Matulonis18

Author affiliations

  • 1 Cruk And Ucl Cancer Trials Centre, UCL Cancer Institute, University College London, WC1E6BT - London/GB
  • 2 Medical Oncology, Sheba Medical Center, Ramat-Gan/IL
  • 3 Gynecologic Oncology, Yale School of Medicine, New Haven/US
  • 4 Oncogynaecology, St. Petersburg City Oncology Hospital, St. Petersburg/RU
  • 5 Dipartimento Uro-ginecologico, Istituto Nazionale Tumori di Napoli, 80131 - Napoli/IT
  • 6 Obstetrics And Gynecology And Gynecologic Oncology, University Hospital Leuven, Leuven/BE
  • 7 Surgery, Fondazione IRCCS Istituto Nazionale Tumori Milan, Milan/IT
  • 8 Medical Oncology, Netherlands Cancer Institute, Amsterdam/NL
  • 9 Hematology & Oncology, The University of Alabama at Birmingham, Birmingham/US
  • 10 Medical Oncology, Centre Hospitalier de L’Université de Montréal, Montreal/CA
  • 11 Medical Oncology, Charité-Medical University of Berlin, Berlin/DE
  • 12 Gynecologic Oncology, University of Milan Bicocca and EIO European Institute of Oncology IRCCS Milan, Milan/IT
  • 13 Medical Oncology, Clinica Universidad de Navarra, Madrid/ES
  • 14 Oncology, Vall d'Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona/ES
  • 15 Medical Oncology, Radboud University Medical Center, Nijmegen/NL
  • 16 Institute Of Clinical Medicine, Vilnius University Faculty of Medicine, Vilnius/LT
  • 17 Medical Oncology, Merck & Co., Inc., 07033 - Kenilworth/US
  • 18 Medical Oncology, Dana-Farber Cancer Institute, 15 - Boston/US


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Abstract 4294


KEYNOTE-100 (NCT02674061) showed pembrolizumab (pembro) has clinical activity in patients (pts) with advanced ovarian cancer (AOC), and PD-L1 expression (combined positive score [CPS] ≥10) was associated with response. Other biomarkers possibly associated with response were evaluated.


Key inclusion criteria included epithelial ovarian, fallopian tube, or primary peritoneal cancer, confirmed recurrence following front-line platinum-based therapy, ECOG PS 0/1, and tumor sample. Pts received pembro 200 mg Q3W IV for 2 y or until progression, death, unacceptable toxicity, or consent withdrawal. Whole exome sequencing of paired tumor and normal samples determined homologous recombination deficiency genomic scar (HRD) and BRCA1/2 mutation status (BRCA) using standard algorithms. Associations of response with T-cell-inflamed 18-gene expression profile (T-cell-GEP) score, HRD, BRCA, and microsatellite instability-high (MSI-H) were evaluated.


T-cell-GEP, BRCA, and HRD data were available from the first 100 pts enrolled, while MSI-H was from the entire study population (n=319). Among patients with T-cell-GEP, distribution of GEP scores was significantly higher in responders than nonresponders (1-sided p=0.03 from Wilcoxon rank sum test; n=83). 7/83 pts (8.4%) had a response. In pts with available PD-L1 CPS and GEP (n=79; Spearman’s correlation ρ=0.57), the area under the receiver characteristic curves for CPS and T-cell-GEP were numerically similar (0.73 vs 0.72, respectively). No statistically significant differences were observed with HRD values among responders and nonresponders (1-sided p=0.29; n=71). No association between BRCA status (n=11 mutant; n=60 wild type) and response was observed (1-sided p=0.65). 6/71 pts (8.5%) in this population had a response. Of 319 paired samples tested for MSI-H, all were MSS.


In addition to PD-L1 CPS, T-cell-GEP was associated with a response to pembro monotherapy for treatment of AOC in a single-arm setting, while HRD biomarkers (HRD, BRCA) were not found to be associated with response.

Clinical trial identification

NCT02674061; release date, February 25, 2016

Editorial Acknowledgement

Medical writing assistance was provided by Christine McCrary Sisk, an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and by Matthew Grzywacz, ApotheCom (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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