PD-L1 as a biomarker of response to immune-checkpoint inhibitors

[1]  Y. Bang,et al.  Association of Tumor Mutational Burden with Efficacy of Pembrolizumab{plus minus}Chemotherapy as First-Line Therapy for Gastric Cancer in the Phase III KEYNOTE-062 Study. , 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

[2]  J. Ross,et al.  Identification and Utilization of Biomarkers to Predict Response to Immune Checkpoint Inhibitors , 2020, The AAPS Journal.

[3]  R. Hunger,et al.  Tumor-Infiltrating Lymphocytes and Their Prognostic Value in Cutaneous Melanoma , 2020, Frontiers in Immunology.

[4]  J. Ajani.  Faculty Opinions recommendation of Efficacy and Safety of Pembrolizumab for Heavily Pretreated Patients With Advanced, Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus: The Phase 2 KEYNOTE-180 Study. , 2020, Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature.

[5]  A. G. van der Heijden,et al.  Prognostic and Predictive Value of Tumor-Infiltrating Immune Cells in Urothelial Cancer of the Bladder , 2020, Cancers.

[6]  David R. Jones,et al.  Neoadjuvant nivolumab plus ipilimumab in resectable non-small cell lung cancer , 2020, Journal for ImmunoTherapy of Cancer.

[7]  L. Pusztai,et al.  PD-L1 Protein Expression on Both Tumor Cells and Macrophages are Associated with Response to Neoadjuvant Durvalumab with Chemotherapy in Triple-negative Breast Cancer , 2020, Clinical Cancer Research.

[8]  E. Sabo,et al.  Spatial heterogeneity of PD-L1 expression and the risk for misclassification of PD-L1 immunohistochemistry in non-small cell lung cancer. , 2020, Lung cancer.

[9]  T. Powles,et al.  Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer. , 2020, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[10]  A. Nicholson,et al.  Tumor Mutation Burden: Promises and Challenges A Perspective from the IASLC Pathology Committee. , 2020, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[11]  T. Powles,et al.  Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. , 2020 .

[12]  Yulei N. Wang,et al.  Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study. , 2020, The Lancet. Oncology.

[13]  S. Loi,et al.  KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. , 2020 .

[14]  P. Ascierto,et al.  Pembrolizumab for previously treated advanced anal squamous cell carcinoma: Pooled results from the KEYNOTE-028 and KEYNOTE-158 studies. , 2020 .

[15]  K. O'Byrne,et al.  Nivolumab + ipilimumab versus platinum-doublet chemotherapy as first-line treatment for advanced non-small cell lung cancer: Three-year update from CheckMate 227 Part 1. , 2020 .

[16]  Yulei N. Wang,et al.  Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. , 2020, The New England journal of medicine.

[17]  J. Roth,et al.  Programmed Death Ligand 1 Heterogeneity and its Impact on Benefit from Immune Checkpoint Inhibitors in Non-Small-Cell Lung Cancer. , 2020, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[18]  K. Kerr,et al.  Programmed Death-Ligand 1 Immunohistochemistry Assay Comparison Studies in NSCLC: Characterization of the 73-10 Assay , 2020 .

[19]  K. Kerr,et al.  PD-L1 Immunohistochemistry Assay Comparison Studies in Non-Small Cell Lung Cancer: Characterization of the 73-10 Assay. , 2020, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[20]  L. Pusztai,et al.  Prospective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer , 2020, Modern Pathology.

[21]  M. Tsao,et al.  Canadian Multicentre Project on Standardization of PD-L1 22C3 Immunohistochemistry Laboratory Developed Tests for Pembrolizumab Therapy in Non-Small Cell Lung Cancer. , 2020, Journal of Thoracic Oncology.

[22]  M. Socinski,et al.  Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous Non-Small-Cell Lung Cancer (IMpower131): Results From a Randomized Phase III Trial. , 2020, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[23]  S. Novello,et al.  Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non-Small-Cell Lung Cancer. , 2020, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[24]  S. Park,et al.  High PD-L1 expression in gastric cancer (GC) patients and correlation with molecular features. , 2020, Pathology, research and practice.

[25]  F. Ehmann,et al.  Implementing the EU in vitro diagnostic regulation – a European regulatory perspective on companion diagnostics , 2020, Expert review of molecular diagnostics.

[26]  Sang-Hoon Ahn,et al.  PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs , 2020, Cancer research and treatment : official journal of Korean Cancer Association.

[27]  K. Almhanna,et al.  Esophageal, gastric cancer and immunotherapy: small steps in the right direction? , 2020, Translational gastroenterology and hepatology.

[28]  K. Molberg,et al.  Effects of Decalcifying Agents of Variable Duration on PD-L1 Immunohistochemistry. , 2020, American journal of clinical pathology.

[29]  N. Girard,et al.  PD-L1 Testing for Lung Cancer in 2019: Perspective from the IASLC Pathology Committee. , 2019, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[30]  C. Couture,et al.  Impact of Specimen Characteristics on PD-L1 Testing in Non-Small Cell Lung Cancer: Validation of the IASLC PD-L1 Testing Guidelines. , 2019, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[31]  Hung-Ming Wang,et al.  Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study , 2019, The Lancet.

[32]  Young Hak Kim,et al.  Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial , 2019, The Lancet.

[33]  D. Pardoll,et al.  Mechanisms regulating PD-L1 expression on tumor and immune cells , 2019, Journal of Immunotherapy for Cancer.

[34]  J. Pfeifer,et al.  The Cancer Immunotherapy Biomarker Testing Landscape. , 2019, Archives of pathology & laboratory medicine.

[35]  V. Patel,et al.  The role of PD-L1 expression as a predictive biomarker: an analysis of all US Food and Drug Administration (FDA) approvals of immune checkpoint inhibitors , 2019, Journal of Immunotherapy for Cancer.

[36]  R. Herbst,et al.  Immune Cell PD-L1 Colocalizes with Macrophages and Is Associated with Outcome in PD-1 Pathway Blockade Therapy , 2019, Clinical Cancer Research.

[37]  S. Digumarthy,et al.  Outcomes to first-line pembrolizumab in patients with non-small-cell lung cancer and very high PD-L1 expression. , 2019, Annals of oncology : official journal of the European Society for Medical Oncology.

[38]  G. Giaccone,et al.  IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC , 2019, Annals of Oncology.

[39]  M. Kudo,et al.  CheckMate 459: A randomized, multi-center phase III study of nivolumab (NIVO) vs sorafenib (SOR) as first-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC) , 2019, Annals of Oncology.

[40]  Baosheng Li,et al.  Pembrolizumab for the treatment of nonsmall cell lung cancer: Current status and future directions , 2019, Journal of cancer research and therapeutics.

[41]  Y. Ohe,et al.  A minimum of 100 tumor cells in a single biopsy sample is required to assess programmed cell death ligand 1 expression in predicting patient response to nivolumab treatment in non-squamous non-small cell lung carcinoma. , 2019, Journal of Thoracic Oncology.

[42]  K. Syrigos,et al.  Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. , 2019, The New England journal of medicine.

[43]  Z. Szallasi,et al.  PD-L1 Expression of Lung Cancer Cells, Unlike Infiltrating Immune Cells, Is Stable and Unaffected by Therapy During Brain Metastasis. , 2019, Clinical lung cancer.

[44]  A. Madabhushi,et al.  Artificial intelligence in digital pathology — new tools for diagnosis and precision oncology , 2019, Nature Reviews Clinical Oncology.

[45]  Chao Li,et al.  “Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy , 2019, Modern Pathology.

[46]  C. Escriu,et al.  Heterogeneity of PD-L1 expression in non-small cell lung cancer: Implications for specimen sampling in predicting treatment response , 2019, Lung cancer.

[47]  N. Rizvi,et al.  Impact of Patient Characteristics, Prior Therapy, and Sample Type on Tumor Cell Programmed Cell Death Ligand 1 Expression in Patients with Advanced NSCLC Screened for the ATLANTIC Study. , 2019, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[48]  FDA approves pembrolizumab for advanced esophageal squamous cell cancer , 2019, Case Medical Research.

[49]  A. Gown,et al.  Quantitative Assessment of PD-L1 as an Analyte in Immunohistochemistry Diagnostic Assays using a Standardized Cell Line Tissue Microarray , 2019, Laboratory Investigation.

[50]  K. Harrington,et al.  The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC) , 2019, Journal of Immunotherapy for Cancer.

[51]  Leizhen Zheng,et al.  Integrated assessment of PD-L1 expression and molecular classification facilitates therapy selection and prognosis prediction in gastric cancer , 2019, Cancer management and research.

[52]  FDA approves pembrolizumab for first-line treatment of head and neck squamous cell carcinoma , 2019, Case Medical Research.

[53]  Y. Bang,et al.  Pembrolizumab with or without chemotherapy versus chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: The phase III KEYNOTE-062 study. , 2019, Journal of Clinical Oncology.

[54]  M. Ahn,et al.  Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[55]  M. Tiemann,et al.  Determination of PD-L1 Expression in Circulating Tumor Cells of NSCLC Patients and Correlation with Response to PD-1/PD-L1 Inhibitors , 2019, Cancers.

[56]  D. Watson,et al.  Novel circulating tumor cell-based blood test for the assessment of PD-L1 protein expression in treatment-naïve, newly diagnosed patients with non-small cell lung cancer , 2019, Cancer Immunology, Immunotherapy.

[57]  Jianying Zhou,et al.  Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial , 2019, The Lancet.

[58]  FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%) , 2019, Case Medical Research.

[59]  A. Italiano,et al.  Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[60]  Ryohei Katayama,et al.  Secreted PD-L1 variants mediate resistance to PD-L1 blockade therapy in non–small cell lung cancer , 2019, The Journal of experimental medicine.

[61]  FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer , 2019, Case Medical Research.

[62]  Z. Szallasi,et al.  Neoantigen-directed immune escape in lung cancer evolution , 2019, Nature.

[63]  T. Powles,et al.  Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal‐Cell Carcinoma , 2019, The New England journal of medicine.

[64]  R. Motzer,et al.  Avelumab plus Axitinib versus Sunitinib for Advanced Renal‐Cell Carcinoma , 2019, The New England journal of medicine.

[65]  P. Hegde,et al.  Development of a PD-L1 Complementary Diagnostic Immunohistochemistry Assay (SP142) for Atezolizumab , 2019, Applied immunohistochemistry & molecular morphology : AIMM.

[66]  J. Wolchok,et al.  Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001 , 2019, Annals of oncology : official journal of the European Society for Medical Oncology.

[67]  N. Ibrahim,et al.  Pembrolizumab treatment of advanced neuroendocrine tumors: Results from the phase II KEYNOTE-158 study. , 2019, Journal of Clinical Oncology.

[68]  Sung-Bae Kim,et al.  Pembrolizumab versus chemotherapy as second-line therapy for advanced esophageal cancer: Phase III KEYNOTE-181 study. , 2019, Journal of Clinical Oncology.

[69]  O. V. Matorin,et al.  Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study , 2019, The Lancet.

[70]  A. Tafreshi,et al.  Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater. , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[71]  K. Goldberg,et al.  FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy , 2018, The oncologist.

[72]  J. Barrett,et al.  PD-L1 and immune infiltrates are differentially expressed in distinct subgroups of gastric cancer , 2018, Oncoimmunology.

[73]  Karin Oien,et al.  Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work , 2018, The journal of pathology. Clinical research.

[74]  T A Chan,et al.  Development of tumor mutation burden as an immunotherapy biomarker: utility for the oncology clinic , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[75]  L. Fashoyin-Aje,et al.  FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1 , 2018, The oncologist.

[76]  J. Lunceford,et al.  Clinical Utility of the Combined Positive Score for Programmed Death Ligand-1 Expression and the Approval of Pembrolizumab for Treatment of Gastric Cancer. , 2018, Archives of pathology & laboratory medicine.

[77]  Sung-Bae Kim,et al.  Efficacy and Safety of Pembrolizumab for Heavily Pretreated Patients With Advanced, Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus: The Phase 2 KEYNOTE-180 Study , 2019, JAMA oncology.

[78]  Robert Klopfleisch,et al.  Digital Microscopy, Image Analysis, and Virtual Slide Repository. , 2018, ILAR journal.

[79]  W. Han,et al.  PD-L1 expression and the prognostic significance in gastric cancer: a retrospective comparison of three PD-L1 antibody clones (SP142, 28–8 and E1L3N) , 2018, Diagnostic Pathology.

[80]  D. Schadendorf,et al.  Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. , 2018, The Lancet. Oncology.

[81]  L. Pusztai,et al.  Immunological differences between primary and metastatic breast cancer , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[82]  E. Winer,et al.  Atezolizumab and Nab‐Paclitaxel in Advanced Triple‐Negative Breast Cancer , 2018, The New England journal of medicine.

[83]  S. Jiao,et al.  A nomogram-based immunoprofile predicts overall survival for previously untreated patients with esophageal squamous cell carcinoma after esophagectomy , 2018, Journal of Immunotherapy for Cancer.

[84]  Matteo Brunelli,et al.  PD-L1 Assays 22C3 and SP263 are Not Interchangeable in Non–Small Cell Lung Cancer When Considering Clinically Relevant Cutoffs: An Interclone Evaluation by Differently Trained Pathologists , 2018, The American journal of surgical pathology.

[85]  A. Mansfield,et al.  First‐Line Atezolizumab plus Chemotherapy in Extensive‐Stage Small‐Cell Lung Cancer , 2018, The New England journal of medicine.

[86]  A. Tafreshi,et al.  Pembrolizumab plus Chemotherapy for Squamous Non–Small‐Cell Lung Cancer , 2018, The New England journal of medicine.

[87]  D. Planchard,et al.  Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC , 2018, The New England journal of medicine.

[88]  Hui Yu,et al.  PD‐L1 Immunohistochemistry Comparability Study in Real‐Life Clinical Samples: Results of Blueprint Phase 2 Project , 2018, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[89]  J. Ajani.  Faculty Opinions recommendation of Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. , 2018, Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature.

[90]  FDA grants nivolumab accelerated approval for third-line treatment of metastatic small cell lung cancer , 2018, Case Medical Research.

[91]  R. Herbst,et al.  A dormant TIL phenotype defines non-small cell lung carcinomas sensitive to immune checkpoint blockers , 2018, Nature Communications.

[92]  Jacob Silterra,et al.  Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab , 2018, Nature Medicine.

[93]  M. Rebelatto,et al.  Consistency of tumor and immune cell programmed cell death ligand-1 expression within and between tumor blocks using the VENTANA SP263 assay , 2018, Diagnostic Pathology.

[94]  L. Schwartz,et al.  The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of non-small cell lung cancer (NSCLC) , 2018, Journal of Immunotherapy for Cancer.

[95]  Yan Guo,et al.  Prognostic significance of programmed death ligand-1 immunohistochemical expression in esophageal cancer , 2018, Medicine.

[96]  M. Kudo,et al.  Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. , 2018, The Lancet. Oncology.

[97]  Kazuhiro Yoshida,et al.  Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial , 2018, The Lancet.

[98]  FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients , 2018, Case Medical Research.

[99]  Boris Sepesi,et al.  Effect of neoadjuvant chemotherapy on the immune microenvironment in non–small cell lung carcinomas as determined by multiplex immunofluorescence and image analysis approaches , 2018, Journal of Immunotherapy for Cancer.

[100]  Federico Cappuzzo,et al.  Atezolizumab for First‐Line Treatment of Metastatic Nonsquamous NSCLC , 2018, The New England journal of medicine.

[101]  J. Mazières,et al.  PD-L1 expression in circulating tumor cells of advanced non-small cell lung cancer patients treated with nivolumab. , 2018, Lung cancer.

[102]  P. Philip,et al.  Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial , 2018, JAMA oncology.

[103]  A. Nicholson,et al.  Expression of PD‐L1 correlates with pleomorphic morphology and histological patterns of non‐small‐cell lung carcinomas , 2018, Histopathology.

[104]  Jianjun Gao,et al.  The emerging role of immunotherapy in advanced urothelial cancers , 2018, Current opinion in oncology.

[105]  V. Prieto,et al.  Programmed death ligand 1 testing in non–small cell lung carcinoma cytology cell block and aspirate smear preparations , 2018, Cancer cytopathology.

[106]  S. Ni,et al.  Programmed death‐ligand 1 expression in gastric cancer: correlation with mismatch repair deficiency and HER2‐negative status , 2018, Cancer medicine.

[107]  Z. Szallasi,et al.  Chemotherapy treatment is associated with altered PD-L1 expression in lung cancer patients , 2018, Journal of Cancer Research and Clinical Oncology.

[108]  S. Novello,et al.  Pembrolizumab plus Chemotherapy in Metastatic Non–Small‐Cell Lung Cancer , 2018, The New England journal of medicine.

[109]  L. Sholl,et al.  Cytologic‐histologic correlation of programmed death‐ligand 1 immunohistochemistry in lung carcinomas , 2018, Cancer cytopathology.

[110]  J. Juco,et al.  Use of the 22C3 anti–programmed death‐ligand 1 antibody to determine programmed death‐ligand 1 expression in cytology samples obtained from non–small cell lung cancer patients , 2018, Cancer cytopathology.

[111]  Bohuslav Melichar,et al.  Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal‐Cell Carcinoma , 2018, The New England journal of medicine.

[112]  T. Schumacher,et al.  Regulation and Function of the PD-L1 Checkpoint. , 2018, Immunity.

[113]  E. Vasile,et al.  PD-L1 mRNA expression in plasma-derived exosomes is associated with response to anti-PD-1 antibodies in melanoma and NSCLC , 2018, British Journal of Cancer.

[114]  Young Hak Kim,et al.  PD-L1 Expression in Small Cell Lung Cancer. , 2018, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[115]  R. Salgia,et al.  Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration trials and future considerations , 2018, Journal of Immunotherapy for Cancer.

[116]  W. Guo,et al.  Immunoclassification characterized by CD8 and PD-L1 expression is associated with the clinical outcome of gastric cancer patients , 2018, Oncotarget.

[117]  J. Adam,et al.  TPF induction chemotherapy increases PD-L1 expression in tumour cells and immune cells in head and neck squamous cell carcinoma , 2018, ESMO Open.

[118]  Clive Taylor,et al.  Development of a Diagnostic Programmed Cell Death 1-Ligand 1 Immunohistochemistry Assay for Nivolumab Therapy in Melanoma , 2017, Applied immunohistochemistry & molecular morphology : AIMM.

[119]  A. Ochiai,et al.  Clinicopathological features of 22C3 PD-L1 expression with mismatch repair, Epstein–Barr virus status, and cancer genome alterations in metastatic gastric cancer , 2018, Gastric Cancer.

[120]  C. Marquette,et al.  Detection of PD-L1 in circulating tumor cells and white blood cells from patients with advanced non-small-cell lung cancer , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[121]  Seung-Yong Jeong,et al.  Chemoradiation-Induced Alteration of Programmed Death-Ligand 1 and CD8+ Tumor-Infiltrating Lymphocytes Identified Patients With Poor Prognosis in Rectal Cancer: A Matched Comparison Analysis. , 2017, International journal of radiation oncology, biology, physics.

[122]  T. Powles,et al.  First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. , 2017, The Lancet. Oncology.

[123]  H. Chung,et al.  Intratumoural PD-L1 expression is associated with worse survival of patients with Epstein–Barr virus-associated gastric cancer , 2017, British Journal of Cancer.

[124]  A. Ribas,et al.  Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006) , 2017, The Lancet.

[125]  J. Heymann,et al.  PD‐L1 expression in non‐small cell lung carcinoma: Comparison among cytology, small biopsy, and surgical resection specimens , 2017, Cancer cytopathology.

[126]  G. Rossi,et al.  PD-L1 expression heterogeneity in non-small cell lung cancer: evaluation of small biopsies reliability , 2017, Oncotarget.

[127]  Nicholas J. Vogelzang,et al.  Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study , 2017, JAMA oncology.

[128]  D. Schadendorf,et al.  Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma , 2017, The New England journal of medicine.

[129]  K. Flaherty,et al.  PDL1 expression in desmoplastic melanoma is associated with tumor aggressiveness and progression , 2017, Journal of the American Academy of Dermatology.

[130]  S. Ha,et al.  Concordance of programmed death-ligand 1 expression between primary and metastatic non-small cell lung cancer by immunohistochemistry and RNA in situ hybridization , 2017, Oncotarget.

[131]  A. Pircher,et al.  PD-L1 expression in bladder cancer and metastasis and its influence on oncologic outcome after cystectomy , 2017, Oncotarget.

[132]  J. Taube,et al.  A Prospective, Multi-institutional, Pathologist-Based Assessment of 4 Immunohistochemistry Assays for PD-L1 Expression in Non–Small Cell Lung Cancer , 2017, JAMA oncology.

[133]  J. Taube,et al.  Melanoma subtypes demonstrate distinct PD-L1 expression profiles. , 2017, Laboratory investigation; a journal of technical methods and pathology.

[134]  G. Pupo,et al.  PD-L1 Expression and Immune Escape in Melanoma Resistance to MAPK Inhibitors , 2017, Clinical Cancer Research.

[135]  Limei Qu,et al.  PD-1 and PD-L1 co-expression predicts favorable prognosis in gastric cancer , 2017, Oncotarget.

[136]  D. Djureinovic,et al.  PD-L1 immunohistochemistry in clinical diagnostics of lung cancer: inter-pathologist variability is higher than assay variability , 2017, Modern Pathology.

[137]  M. Socinski,et al.  First‐Line Nivolumab in Stage IV or Recurrent Non–Small‐Cell Lung Cancer , 2017, The New England journal of medicine.

[138]  Li Zhang,et al.  Association between PD-L1 Expression on Tumour-Infiltrating Lymphocytes and Overall Survival in Patients with Gastric Cancer , 2017, Journal of Cancer.

[139]  Y. Ohe,et al.  PD-L1 expression in neuroendocrine tumors of the lung. , 2017, Lung cancer.

[140]  K. Goldberg,et al.  FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy , 2017, The oncologist.

[141]  H. Rugo,et al.  Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[142]  Y. Shim,et al.  Programmed Death Ligand 1 Expression in Paired Non–Small Cell Lung Cancer Tumor Samples , 2017, Clinical lung cancer.

[143]  K. Goldberg,et al.  FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy , 2017, The oncologist.

[144]  S. Fox,et al.  Intra- and Interobserver Reproducibility Assessment of PD-L1 Biomarker in Non–Small Cell Lung Cancer , 2017, Clinical Cancer Research.

[145]  Young A Kim,et al.  Comparative analysis of PD-L1 expression between primary and metastatic pulmonary adenocarcinomas. , 2017, European journal of cancer.

[146]  M. Mino‐Kenudson,et al.  Programmed Cell Death Ligand (PD‐L1) Expression in Stage II and III Lung Adenocarcinomas and Nodal Metastases , 2017, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[147]  E. Plimack,et al.  Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. , 2017, The Lancet. Oncology.

[148]  L. Essioux,et al.  Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch , 2017, Clinical and translational science.

[149]  Jianming Xu,et al.  Prognostic significance of tumor-infiltrating immune cells and PD-L1 expression in esophageal squamous cell carcinoma , 2017, Oncotarget.

[150]  S. Culine,et al.  Pembrolizumab as Second‐Line Therapy for Advanced Urothelial Carcinoma , 2017, The New England journal of medicine.

[151]  F. Hirsch,et al.  PD‐L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD‐L1 IHC Assay Comparison Project , 2017, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[152]  Carlos Barrios,et al.  Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial , 2017, The Lancet.

[153]  Alan Sharpe,et al.  Agreement between Programmed Cell Death Ligand-1 Diagnostic Assays across Multiple Protein Expression Cutoffs in Non–Small Cell Lung Cancer , 2017, Clinical Cancer Research.

[154]  R. Bourgon,et al.  Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial , 2017, The Lancet.

[155]  E. Gabrielson,et al.  Heterogeneous expression of PD-L1 in pulmonary squamous cell carcinoma and adenocarcinoma: implications for assessment by small biopsy , 2017, Modern Pathology.

[156]  Yingyong Hou,et al.  Independent prognostic role of PD-L1 expression in patients with esophageal squamous cell carcinoma , 2016, Oncotarget.

[157]  C. Slingluff,et al.  PD-L1, PD-L2 and PD-1 expression in metastatic melanoma: Correlation with tumor-infiltrating immune cells and clinical outcome , 2016, Oncoimmunology.

[158]  M. Dolled-Filhart,et al.  Development of a Prototype Immunohistochemistry Assay to Measure Programmed Death Ligand-1 Expression in Tumor Tissue. , 2016, Archives of pathology & laboratory medicine.

[159]  W. Weichert,et al.  The Role of PD-L1 Expression and Intratumoral Lymphocytes in Response to Perioperative Chemotherapy for Urothelial Carcinoma , 2016, Bladder cancer.

[160]  K. Harrington,et al.  Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. , 2016, The New England journal of medicine.

[161]  Y. Shentu,et al.  Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. , 2016, The New England journal of medicine.

[162]  Steven J. M. Jones,et al.  Investigation of PD-L1 Biomarker Testing Methods for PD-1 Axis Inhibition in Non-squamous Non–small Cell Lung Cancer , 2016, The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society.

[163]  A. Mansfield,et al.  Temporal and spatial discordance of programmed cell death-ligand 1 expression and lymphocyte tumor infiltration between paired primary lesions and brain metastases in lung cancer , 2016, Annals of oncology : official journal of the European Society for Medical Oncology.

[164]  D. Jäger,et al.  Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. , 2016, The Lancet. Oncology.

[165]  R. Bourgon,et al.  Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial , 2016, The Lancet.

[166]  Keunchil Park,et al.  Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial , 2016, The Lancet.

[167]  Y. Shentu,et al.  Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial , 2016, The Lancet.

[168]  Daniela Massi,et al.  PD-L1 expression in cancer patients receiving anti PD-1/PD-L1 antibodies: A systematic review and meta-analysis. , 2016, Critical reviews in oncology/hematology.

[169]  P. Keegan,et al.  FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1 , 2016, The oncologist.

[170]  G. Mann,et al.  PD-L1 Negative Status is Associated with Lower Mutation Burden, Differential Expression of Immune-Related Genes, and Worse Survival in Stage III Melanoma , 2016, Clinical Cancer Research.

[171]  N. Chen,et al.  Expression of programmed death ligand-1 on tumor cells varies pre and post chemotherapy in non-small cell lung cancer , 2016, Scientific Reports.

[172]  F. Hirsch,et al.  Programmed Death Ligand-1 Immunohistochemistry: Friend or Foe? , 2016, Archives of pathology & laboratory medicine.

[173]  C. Marquette,et al.  Comparative study of the PD-L1 status between surgically resected specimens and matched biopsies of NSCLC patients reveal major discordances: a potential issue for anti-PD-L1 therapeutic strategies. , 2016, Annals of oncology : official journal of the European Society for Medical Oncology.

[174]  P. Jänne,et al.  Expression of PD-1 and Its Ligands, PD-L1 and PD-L2, in Smokers and Never Smokers with KRAS-Mutant Lung Cancer , 2015, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[175]  Xiaoling Zhang,et al.  Development of an Automated PD-L1 Immunohistochemistry (IHC) Assay for Non–Small Cell Lung Cancer , 2015, Applied immunohistochemistry & molecular morphology : AIMM.

[176]  L. Crinò,et al.  Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. , 2015, The New England journal of medicine.

[177]  Ming-Sound Tsao,et al.  Programmed Death-Ligand 1 Immunohistochemistry in Lung Cancer: In what state is this art? , 2015, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[178]  Antoni Ribas,et al.  Classifying Cancers Based on T-cell Infiltration and PD-L1. , 2015, Cancer research.

[179]  J. Lunceford,et al.  Pembrolizumab for the treatment of non-small-cell lung cancer. , 2015, The New England journal of medicine.

[180]  C. Drake,et al.  Immune checkpoint blockade: a common denominator approach to cancer therapy. , 2015, Cancer cell.

[181]  D. Schadendorf,et al.  Nivolumab in previously untreated melanoma without BRAF mutation. , 2015, The New England journal of medicine.

[182]  W. Travis.  WHO classification of tumours of the lung, pleura, thymus and heart , 2015 .

[183]  H. Kohrt,et al.  Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients , 2014, Nature.

[184]  P. Hegde,et al.  MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer , 2014, Nature.

[185]  J. Taube,et al.  Association of PD-1, PD-1 Ligands, and Other Features of the Tumor Immune Microenvironment with Response to Anti–PD-1 Therapy , 2014, Clinical Cancer Research.

[186]  Linda A Bradley,et al.  Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center. , 2014, Archives of pathology & laboratory medicine.

[187]  Travis J Cohoon,et al.  Activation of the PD-1 pathway contributes to immune escape in EGFR-driven lung tumors. , 2013, Cancer discovery.

[188]  David C. Smith,et al.  Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. , 2012, The New England journal of medicine.

[189]  Alison P. Klein,et al.  Colocalization of Inflammatory Response with B7-H1 Expression in Human Melanocytic Lesions Supports an Adaptive Resistance Mechanism of Immune Escape , 2012, Science Translational Medicine.

[190]  Drew M. Pardoll,et al.  The blockade of immune checkpoints in cancer immunotherapy , 2012, Nature Reviews Cancer.

[191]  J. Geddes,et al.  What is a randomised controlled trial? , 2009, Epidemiologia e Psichiatria Sociale.

[192]  A. Mackensen,et al.  Interaction of PD-L1 on tumor cells with PD-1 on tumor-specific T cells as a mechanism of immune evasion: implications for tumor immunotherapy , 2005, Cancer Immunology, Immunotherapy.

[193]  Sofamor Danek,et al.  SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) , 2004 .

[194]  Yoshimasa Tanaka,et al.  Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade , 2002, Proceedings of the National Academy of Sciences of the United States of America.

[195]  J. Minna,et al.  Markedly decreased expression of class I histocompatibility antigens, protein, and mRNA in human small-cell lung cancer , 1985, The Journal of experimental medicine.