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

2989 - Prevalence of PD-L1 expression in patients with non-small cell lung cancer screened for enrollment in KEYNOTE-001, -010, and -024


09 Oct 2016


Poster display


Charu Aggarwal


Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378


C. Aggarwal1, D. Rodriguez Abreu2, E. Felip3, E. Carcereny4, M. Gottfried5, T. Wehler6, M. Ahn7, M. Dolled-Filhart8, J. Zhang8, Y. Shentu8, R. Rangwala8, B. Piperdi8, P. Baas9

Author affiliations

  • 1 Medicine, University of Pennsylvania-Perelman Center for Advanced Medicine, 19104 - Philadelphia/US
  • 2 Medcal Oncology Service, Hospital Universitario Insular de Gran Canaria, 35016 - Las Palmas/ES
  • 3 Oncologia Médica, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 4 Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona/ES
  • 5 Oncology, Meir Medical Center, Kfar Saba/IL
  • 6 Oncology, Universitätsmedizin Mainz, Mainz/DE
  • 7 Medical Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul/KR
  • 8 Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 9 Thoracic Oncology, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL


Abstract 2989


The anti–PD-1 humanized monoclonal antibody pembrolizumab has recently been approved in the United States to treat metastatic non–small cell lung cancer (NSCLC) in patients (pts) who are PD-L1 positive and have progressed on platinum therapy and an EGFR/ALK inhibitor if EGFR/ALK positive. Here, we report on the prevalence of PD-L1 expression in pts screened for enrollment in 3 global clinical trials that investigated the efficacy and safety of pembrolizumab in pts with advanced NSCLC: KEYNOTE-001 (NCT01295827), KEYNOTE-010 (NCT01905657), and KEYNOTE-024 (NCT02142738).


All 3 studies required provision of a tumor sample (archival or newly obtained) for PD-L1 testing as an entry criterion. PD-L1 expression was determined using the companion diagnostic PD-L1 IHC 22C3 pharmDx assay. PD-L1 expression was determined based on percentage of tumor cells with positive membranous staining and was reported as the tumor proportion score (TPS).


A total of 5879 pts were screened for eligibility in KEYNOTE-001 (n = 1242), KEYNOTE-010 (n = 2699), and KEYNOTE-024 (n = 1938). Of these, 4784 (81%) were evaluable for PD-L1; 1596 (33%) had TPS


This is one of the largest data sets of PD-L1 expression determined by an FDA-approved companion diagnostic in pts with advanced NSCLC screened for pembrolizumab therapy. 68% of pts with advanced NSCLC had PD-L1 TPS ≥1% and 28% had PD-L1 TPS ≥50%. The prevalence is similar across prior lines of therapy and different disease characteristics examined.

Clinical trial identification

KEYNOTE-001: ClinicalTrials.gov NCT01295827; KEYNOTE-010: ClinicalTrials.gov NCT01905657; KEYNOTE-024: ClinicalTials.gov NCT02142738

Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.


C. Aggarwal: Advisory Board member at Roche. E. Felip: Consulting for Lilly, Pfizer, Roche, Boehringer Ingelheim Speaker Bureau for BMS, Novartis, Astra Zeneca. M-J. Ahn: Consulting for Boehringer Ingelheim, Novartis, Astra Zeneca Research Funding for Astra Zeneca. M. Dolled-Filhart, Y. Shentu, R. Rangwala, B. Piperdi: Employee of Merck & Co. J. Zhang: Employee of Merck. P. Baas: Advisory board for BMS, MSD, Aduro. 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