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Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non small-cell lung cancer: The global, multicenter EXPRESS study
Univ Med Berlin, Charite, Inst Pathol, Berlin, Germany.
Moscow City Oncol Hosp 62, Dept Pathol, Moscow, Russia.
Hosp Gastroenterol Dr Carlos Bonorino Udaondo, Dept Pathol, Buenos Aires, DF, Argentina.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Clinical and experimental pathology.ORCID iD: 0000-0003-1210-5961
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2019 (English)In: Lung Cancer, ISSN 0169-5002, E-ISSN 1872-8332, Vol. 134, p. 174-179Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2019. Vol. 134, p. 174-179
Keywords [en]
non-small-cell lung cancer, PD-L1, Biomarker, Prevalence
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-393123DOI: 10.1016/j.lungcan.2019.06.012ISI: 000478707200025PubMedID: 31319978OAI: oai:DiVA.org:uu-393123DiVA, id: diva2:1353997
Available from: 2019-09-24 Created: 2019-09-24 Last updated: 2019-09-24Bibliographically approved

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Micke, Patrick

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