immunotherapy of cancer

1 downloads 0 Views 48KB Size Report
Jan 8, 2018 - cell lung cancer screened for enrollment in KEYNOTE-001, ... Background: The anti-PD-1 humanized monoclonal antibody pembrolizumab has.

Annals of Oncology 27 (Supplement 6): vi359–vi378, 2016 doi:10.1093/annonc/mdw378.14

9. Continued

immunotherapy of cancer

Pooled NSCLC population

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

C. Aggarwal1, D. Rodriguez Abreu2, E. Felip3, E. Carcereny4, M. Gottfried5, T. Wehler6, M-J. Ahn7, M. Dolled-Filhart8, J. Zhang8, Y. Shentu8, R. Rangwala8, B. Piperdi8, P. Baas9 1 Medicine, University of Pennsylvania-Perelman Center for Advanced Medicine, Philadelphia, PA, USA, 2Medcal Oncology service, Hospital Universitario Insular de Gran Canaria, Las Palmas, Spain, 3Medical Oncology, Vall d’Hebron University Hospital Institut d’Oncologia, Barcelona, Spain, 4Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona, Spain, 5 Oncology, Meir Medical Center, Kfar Saba, Israel, 6Oncology, Universitätsmedizin Mainz, Mainz, Germany, 7Medical Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 8Medical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA, 9Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands Background: 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). Methods: 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). Results: 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