Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer

The global, multicenter EXPRESS study

M. Dietel, N. Savelov, R. Salanova, P. Micke, G. Bigras, T. Hida, J. Antunez, B. Guldhammer Skov, G. Hutarew, L. F. Sua, H. Akita, O. S.H. Chan, Bilal Piperdi, T. Burke, S. Khambata-Ford, A. C. Deitz

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)174-179
Number of pages6
JournalLung Cancer
Volume134
DOIs
StatePublished - Aug 1 2019
Externally publishedYes

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Non-Small Cell Lung Carcinoma
Multicenter Studies
Ligands
Neoplasms
Mutation
Immunotherapy
Observational Studies
Retrospective Studies
Clinical Trials

Keywords

  • Biomarker
  • non–small-cell lung cancer
  • PD-L1
  • Prevalence

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer : The global, multicenter EXPRESS study. / Dietel, M.; Savelov, N.; Salanova, R.; Micke, P.; Bigras, G.; Hida, T.; Antunez, J.; Guldhammer Skov, B.; Hutarew, G.; Sua, L. F.; Akita, H.; Chan, O. S.H.; Piperdi, Bilal; Burke, T.; Khambata-Ford, S.; Deitz, A. C.

In: Lung Cancer, Vol. 134, 01.08.2019, p. 174-179.

Research output: Contribution to journalArticle

Dietel, M, Savelov, N, Salanova, R, Micke, P, Bigras, G, Hida, T, Antunez, J, Guldhammer Skov, B, Hutarew, G, Sua, LF, Akita, H, Chan, OSH, Piperdi, B, Burke, T, Khambata-Ford, S & Deitz, AC 2019, 'Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer: The global, multicenter EXPRESS study', Lung Cancer, vol. 134, pp. 174-179. https://doi.org/10.1016/j.lungcan.2019.06.012
Dietel, M. ; Savelov, N. ; Salanova, R. ; Micke, P. ; Bigras, G. ; Hida, T. ; Antunez, J. ; Guldhammer Skov, B. ; Hutarew, G. ; Sua, L. F. ; Akita, H. ; Chan, O. S.H. ; Piperdi, Bilal ; Burke, T. ; Khambata-Ford, S. ; Deitz, A. C. / Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer : The global, multicenter EXPRESS study. In: Lung Cancer. 2019 ; Vol. 134. pp. 174-179.
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abstract = "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.",
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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, Bilal

AU - Burke, T.

AU - Khambata-Ford, S.

AU - Deitz, A. C.

PY - 2019/8/1

Y1 - 2019/8/1

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 - non–small-cell lung cancer

KW - PD-L1

KW - Prevalence

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U2 - 10.1016/j.lungcan.2019.06.012

DO - 10.1016/j.lungcan.2019.06.012

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JF - Lung Cancer

SN - 0169-5002

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