1060P - Prevalence of PD-L1 expression in patients with non-small cell lung cancer screened for enrollment in KEYNOTE-001, -010, and -024

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Immunotherapy
Presenter Charu Aggarwal
Citation Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378
Authors 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
  • 1Medicine, University of Pennsylvania-Perelman Center for Advanced Medicine, 19104 - Philadelphia/US
  • 2Medcal Oncology Service, Hospital Universitario Insular de Gran Canaria, 35016 - Las Palmas/ES
  • 3Oncologia Médica, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 4Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona/ES
  • 5Oncology, Meir Medical Center, Kfar Saba/IL
  • 6Oncology, Universitätsmedizin Mainz, Mainz/DE
  • 7Medical Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul/KR
  • 8Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 9Thoracic Oncology, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL



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.