PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project

Journal of Thoracic Oncology - Tập 12 - Trang 208-222 - 2017
Fred R. Hirsch1,2, Abigail McElhinny3, Dave Stanforth4, James Ranger-Moore5, Malinka Jansson4, Karina Kulangara4, William Richardson5, Penny Towne5, Debra Hanks4, Bharathi Vennapusa5, Amita Mistry5, Rasika Kalamegham6,7, Steve Averbuch8, James Novotny8, Eric Rubin9, Kenneth Emancipator9, Ian McCaffery10,11, J. Andrew Williams10, Jill Walker12, John Longshore13
1Medicine and Pathology, University of Colorado Cancer Center, Aurora, Colorado
2International Association for the Study of Lung Cancer, Aurora, Colorado
3Personal Genome Diagnostics, Baltimore, Maryland
4Dako North America, Agilent Technologies, Carpinteria, California
5Ventana Medical Systems, Inc., Roche Tissue Diagnostics, Tucson, Arizona
6American Association for Cancer Research, Washington, DC
7Genentech, Washington, DC
8Development, Oncology and Pharmacodiagnostics, Bristol-Myers Squibb Company, Princeton, New Jersey
9Merck & Co Inc, Kenilworth, New Jersey
10Genentech, Oncology Biomarkers Development, South San Francisco, California
11Corvus Pharmaceuticals, Burlingame, California
12AstraZeneca, Cambridge, United Kingdom
13Carolinas Pathology Group, Carolinas HealthCare System, Charlotte, North Carolina

Tài liệu tham khảo

Gettinger, 2015, Molecular, immune and histopathological characterization of NSCLC based on PDL1 expression on tumor and immune cells and association with response to the anti-PDL1 antibody MPDL3280A, J Clin Oncol, 33, 3015, 10.1200/jco.2015.33.15_suppl.3015 Garon, 2015, Pembrolizumab for the treatment of non-small-cell lung cancer, N Engl J Med, 372, 2018, 10.1056/NEJMoa1501824 Herbst, 2016, Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial, Lancet, 387, 1540, 10.1016/S0140-6736(15)01281-7 Borghaei, 2015, Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer, N Engl J Med, 373, 1627, 10.1056/NEJMoa1507643 Rizvi, 2015, Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial, Lancet Oncol, 16, 257, 10.1016/S1470-2045(15)70054-9 Brahmer, 2015, Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer, N Engl J Med, 373, 123, 10.1056/NEJMoa1504627 Rizvi, 2015, Safety and clinical activity of MEDI4736, an anti-programmed cell death-ligand 1 (PD-L1) antibody, in patients with non-small cell lung cancer (NSCLC), J Clin Oncol, 33, 8032, 10.1200/jco.2015.33.15_suppl.8032 Spigel, 2015, Clinical activity and safety from a phase II study (FIR) of MPDL3280A (anti-PDL1) in PD-L1-selected patients with non-small cell lung cancer (NSCLC), J Clin Oncol, 33, 8028, 10.1200/jco.2015.33.15_suppl.8028 Fehrenbacher, 2016, Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial, Lancet, 387, 1837, 10.1016/S0140-6736(16)00587-0 Herbst, 2014, Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients, Nature, 515, 563, 10.1038/nature14011 Merck and Company, Inc. FDA approves Merck's KEYTRUDA (pembrolizumab) in metastatic NSCLC for first-line treatment of patients whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK genomic tumor aberrations. http://wwwmercknewsroomcom/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-metastatic-nsclc-. Accessed November 10, 2016. U.S. Food and Drug Administration. Nivolumab (Obdivo). http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436566.htm. Accessed November 10, 2016. U.S. Food and Drug Administration. FDA approves Keytruda for advanced non-small cell lung cancer. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465444.htm. Accessed November 10, 2016. Roche: Media release: Roche receives FDA approval for novel PD-L1 biomarker assay. http://www.ventana.com/pd-l1-biomarker-assay-news. Accessed November 10, 2016. Dako PD-L1 IHC 28-8 pharmDX IFU. http://www.agilent.com/en-us/products/pharmdx/pd-l1-ihc-28-8-overview. Accessed November 10, 2016. Dako PD-L1 IHC Pharm testing. http://www.agilent.com/en-us/products/pharmdx/pd-l1-ihc-22c3-pharmdx-testing. Accessed November 10, 2016. Kerr, 2015, Programmed death-ligand 1 immunohistochemistry in lung cancer: in what state is this art?, J Thorac Oncol, 10, 985, 10.1097/JTO.0000000000000526 Cagle, 2015, Challenges to biomarker testing for PD-1/PD-L1 checkpoint inhibitors for lung cancer, Arch Pathol Lab Med, 139, 1477, 10.5858/arpa.2015-0902-ED Kerr, 2016, Programmed death ligand-1 immunohistochemistry: friend or foe?, Arch Pathol Lab Med, 140, 326, 10.5858/arpa.2015-0522-SA U.S. Food and Drug Administration. A blueprint proposal for companion diagnostic comparability. http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM439440.pdf. Accessed November 10, 2016. Phillips, 2015, Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer, Appl Immunohistochem Mol Morphol, 23, 541, 10.1097/PAI.0000000000000256 Roach, 2016, Development of a companion diagnostic PD-L1 immunohistochemistry assay for pembrolizumab therapy in non-small-cell lung cancer, Appl Immunohistochem Mol Morphol, 24, 392, 10.1097/PAI.0000000000000408 Rebelatto, 2016, Development of a programmed cell death ligand-1 immunohistochemical assay validated for analysis of non-small cell lung cancer and head and neck squamous cell carcinoma, Diagn Pathol, 11, 95, 10.1186/s13000-016-0545-8 Ilie, 2016, Comparative study of the PD-L1 status between surgically resectedspecimens and matched biopsied of NSCLC patients reveal major discordances: a potential issue for anti-PD-L1 therapeutic strategies, Ann Oncol, 27, 147, 10.1093/annonc/mdv489 Scheel, 2016, Harmonized PD-L1 immunohistochemistry for pulmonary squamous-cell and adenocarcinomas, Mod Pathol, 29, 1165, 10.1038/modpathol.2016.117 Ruschoff, 2013, Reproducibility of immunohistochemical scoring for epidermal growth factor receptor expression in non-small cell lung cancer: round robin test, Arch Pathol Lab Med, 137, 1255, 10.5858/arpa.2012-0605-OA Fitzgibbons, 2014, Principles of analytic validation of immunohistochemical assays: guideline from the College of American Pathologists Pathology and Laboratory Quality Center, Arch Pathol Lab Med, 138, 1432, 10.5858/arpa.2013-0610-CP Lin, 2014, Standardization of diagnostic immunohistochemistry: literature review and geisinger experience, Arch Pathol Lab Med, 138, 1564, 10.5858/arpa.2014-0074-RA Dolled-Filhart, 2015, Development of a PD-L1 immunohistochemistry (IHC) assay for use as a companion diagnostic for pembrolizumab (MK-3475) in non-small cell lung cancer (NSCLC), J Clin Oncol, 33, 11065, 10.1200/jco.2015.33.15_suppl.11065 Rebelatto, 2015, Development of a PD-L1 companion diagnostic assay for treatment with MEDI4736 in NSCLC and SCCHN patients, J Clin Oncol, 33, 8033, 10.1200/jco.2015.33.15_suppl.8033 Neuman, 2016, A harmonization study for the use of 22C3 PD-L1 immunohistochemical staining on Ventana's platform, J Thorac Oncol, 11, 1863, 10.1016/j.jtho.2016.08.146 Ibrahim, 2016, ALK Immunohistochemistry in NSCLC: discordant staining can impact patient treatment regimen, J Thorac Oncol, 11, 2241, 10.1016/j.jtho.2016.07.012 Wolff, 2007, American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer, Arch Pathology Lab Med, 131, 18, 10.5858/2007-131-18-ASOCCO Patel, 2015, PD-L1 expression as a predictive biomarker in cancer immunotherapy, Mol Cancer Ther, 14, 847, 10.1158/1535-7163.MCT-14-0983