TY - JOUR
T1 - Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer
T2 - The global, multicenter EXPRESS study
AU - Dietel, M.
AU - Savelov, N.
AU - Salanova, R.
AU - Micke, P.
AU - Bigras, G.
AU - Hida, T.
AU - Antunez, J.
AU - Guldhammer Skov, B.
AU - Hutarew, G.
AU - Sua, L. F.
AU - Akita, H.
AU - Chan, O. S.H.
AU - Piperdi, B.
AU - Burke, T.
AU - Khambata-Ford, S.
AU - Deitz, A. C.
N1 - Funding Information:
This work was supported by Merck Sharp & Dohme Corp. , a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. No grant number is applicable.
Funding Information:
Study execution and analysis support provided by Parexel (Waltham, MA, USA); pathologist training conducted by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Kenilworth, NJ, USA) and Targos Molecular Pathology, Inc. (Kassel, Germany); and the 22C3 pharmDx RUO kit distributed by Agilent (Santa Clara, CA, USA). Project management support provided by Shikha Surati of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Kenilworth, NJ, USA). We thank the patients and their families and caregivers for participating in this study, along with all investigators and site personnel. Medical writing and editorial assistance were provided by Mayur Kapadia, MD, of C4 MedSolutions, LLC (Yardley, PA, USA), a CHC Group company. This assistance was funded by Merck & Co., Inc.
Publisher Copyright:
© 2019 Elsevier B.V.
PY - 2019/8
Y1 - 2019/8
N2 - Objectives:: Tumor programmed death ligand 1 (PD-L1) expression is associated with improved clinical benefit from immunotherapies targeting the PD-1 pathway. We conducted a global, multicenter, retrospective observational study to determine real-world prevalence of tumor PD-L1 expression in patients with NSCLC. Materials and methods:: Patients ≥18 years with histologically confirmed stage IIIB/IV NSCLC and a tumor tissue block (≤5 years old) obtained before treatment were identified in 45 centers across 18 countries. Tumor samples from eligible patients were selected consecutively, when possible. PD-L1 expression was evaluated at each center using the PD-L1 IHC 22C3 pharmDx kit (Agilent, Santa Clara, CA, USA). Results:: Of 2617 patients who met inclusion criteria, 2368 (90%) had PD-L1 data; 530 (22%) patients had PD-L1 TPS ≥ 50%, 1232 (52%) had PD-L1 TPS ≥ 1%, and 1136 (48%) had PD-L1 TPS < 1%. The most common reason for not having PD-L1 data (n = 249) was insufficient tumor cells (<100) on the slide (n = 170 [6%]). Percentages of patients with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively were: 22%/52% in Europe; 22%/53% in Asia Pacific; 21%/47% in the Americas, and 24%/55% in other countries. Prevalence of EGFR mutations (19%) and ALK alterations (3%) was consistent with prior reports from metastatic NSCLC studies. Among 1064 patients negative for both EGFR mutation and ALK alteration, the percentage with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively, were 27% and 53%. Conclusions:: This is the largest real-world study in advanced NSCLC to date evaluating PD-L1 tumor expression using the 22C3 pharmDx kit. Testing failure rate was low with local evaluation of PD-L1 TPS across a large number of centers. Prevalence of PD-L1 TPS ≥ 50% and TPS ≥ 1% among patients with stage IIIB/IV NSCLC was similar across geographic regions and broadly consistent with central testing results from clinical trial screening populations.
AB - Objectives:: Tumor programmed death ligand 1 (PD-L1) expression is associated with improved clinical benefit from immunotherapies targeting the PD-1 pathway. We conducted a global, multicenter, retrospective observational study to determine real-world prevalence of tumor PD-L1 expression in patients with NSCLC. Materials and methods:: Patients ≥18 years with histologically confirmed stage IIIB/IV NSCLC and a tumor tissue block (≤5 years old) obtained before treatment were identified in 45 centers across 18 countries. Tumor samples from eligible patients were selected consecutively, when possible. PD-L1 expression was evaluated at each center using the PD-L1 IHC 22C3 pharmDx kit (Agilent, Santa Clara, CA, USA). Results:: Of 2617 patients who met inclusion criteria, 2368 (90%) had PD-L1 data; 530 (22%) patients had PD-L1 TPS ≥ 50%, 1232 (52%) had PD-L1 TPS ≥ 1%, and 1136 (48%) had PD-L1 TPS < 1%. The most common reason for not having PD-L1 data (n = 249) was insufficient tumor cells (<100) on the slide (n = 170 [6%]). Percentages of patients with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively were: 22%/52% in Europe; 22%/53% in Asia Pacific; 21%/47% in the Americas, and 24%/55% in other countries. Prevalence of EGFR mutations (19%) and ALK alterations (3%) was consistent with prior reports from metastatic NSCLC studies. Among 1064 patients negative for both EGFR mutation and ALK alteration, the percentage with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively, were 27% and 53%. Conclusions:: This is the largest real-world study in advanced NSCLC to date evaluating PD-L1 tumor expression using the 22C3 pharmDx kit. Testing failure rate was low with local evaluation of PD-L1 TPS across a large number of centers. Prevalence of PD-L1 TPS ≥ 50% and TPS ≥ 1% among patients with stage IIIB/IV NSCLC was similar across geographic regions and broadly consistent with central testing results from clinical trial screening populations.
KW - Biomarker
KW - PD-L1
KW - Prevalence
KW - non–small-cell lung cancer
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U2 - 10.1016/j.lungcan.2019.06.012
DO - 10.1016/j.lungcan.2019.06.012
M3 - Article
C2 - 31319978
AN - SCOPUS:85067795598
SN - 0169-5002
VL - 134
SP - 174
EP - 179
JO - Lung Cancer
JF - Lung Cancer
ER -
