Development of a PD-L1 Complementary Diagnostic Immunohistochemistry Assay (SP142) for Atezolizumab

Applied Immunohistochemistry and Molecular Morphology

Volumn 27, Issue 2, 2019, Pages 92-100

  Vennapusa, Bharathi ^a   Baker, Brian ^a   Kowanetz, Marcin ^b   Boone, Jennifer ^a   Menzl, Ina ^a   Bruey, Jean Marie ^b   Fine, Gregg ^b   Mariathasan, Sanjeev ^b   McCaffery, Ian ^b   Mocci, Simonetta ^b   Rost, Sandra ^b   Smith, Dustin ^b   Dennis, Eslie ^a   Tang, Szu Yu ^a   Damadzadeh, Bita ^a   Walker, Espen ^a   Hegde, Priti S ^b   Williams, J Andrew ^b   Koeppen, Hartmut ^b   Boyd, Zachary ^b  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b GENENTECH INC   (United States)

Author keywords

atezolizumab; cancer immunotherapy; diagnostic assay; immunohistochemistry; PD L1; SP142

Indexed keywords

ATEZOLIZUMAB; CD163 ANTIGEN; CD8 ANTIGEN; EOSIN; HEMATOXYLIN; PROGRAMMED DEATH 1 LIGAND 1; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; TUMOR MARKER;

ACCURACY; ANTIBODY BLOOD LEVEL; ANTIGEN RETRIEVAL; ARTICLE; BOOTSTRAPPING; COMPARATIVE STUDY; CONTROLLED STUDY; DENDRITIC CELL; GRANULOCYTE; HUMAN; HUMAN TISSUE; IMMUNOCOMPETENT CELL; IMMUNOCYTOCHEMISTRY; IMMUNOHISTOCHEMISTRY; LYMPHOCYTE; MACROPHAGE; MEASUREMENT REPEATABILITY; NON SMALL CELL LUNG CANCER; NONHUMAN; PATHOLOGIST; PRIORITY JOURNAL; PROTEIN EXPRESSION; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STAINING; TRANSITIONAL CELL CARCINOMA; TUMOR ASSOCIATED LEUKOCYTE; TUMOR CELL; TUMOR MICROENVIRONMENT; BLADDER TUMOR; GENE EXPRESSION REGULATION; IMMUNOLOGY; IMMUNOTHERAPY; LUNG TUMOR; METABOLISM; OBSERVER VARIATION; PATIENT SELECTION; PROCEDURES;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; B7-H1 ANTIGEN; BIOMARKERS, TUMOR; CARCINOMA, NON-SMALL-CELL LUNG; GENE EXPRESSION REGULATION, NEOPLASTIC; HUMANS; IMMUNOHISTOCHEMISTRY; IMMUNOTHERAPY; LUNG NEOPLASMS; OBSERVER VARIATION; PATIENT SELECTION; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; URINARY BLADDER NEOPLASMS;

EID: 85041577247     PISSN: 15412016     EISSN: 15334058     Source Type: Journal    
DOI: 10.1097/PAI.0000000000000594     Document Type: Article

References (22)

1. Chen DS, Irving BA, Hodi FS. Molecular pathways: next-generation immunotherapy-inhibiting programmed death-ligand 1 and programmed death-1. Clin Cancer Res. 2012;15:6580-6587.
2. Chen DS, Mellman I. Oncology meets immunology: the cancerimmunity cycle. Immunity. 2013;25:1-10.
3. Latchman Y,Wood CR, Chernova T, et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol. 2001;2: 261-268.
4. Matsumoto K, Fukuyama S, Eguchi-Tsuda M, et al. B7-DC induced by IL-13 works as a feedback regulator in the effector phase of allergic asthma. Biochem Biophys Res Commun. 2008;365:170-175.
5. Akbari O, Stock P, Singh AK, et al. PD-L1 and PD-L2 modulate airway inflammation and iNKT-cell-dependent airway hyperreactivity in opposing directions. Mucosal Immunol. 2010;3:81-91.
6. Spigel DR, Chaft JE, Gettinger SN, et al. Clinical activity and safety from a phase II study (FIR) of MPDL3280A (anti-PDL1) in PDL1-selected patients with non-small cell lung cancer (NSCLC). J Clin Oncol. 2015;33 suppl:abstr 8028.
7. Herbst RS, Soria JC, Kowanetz M, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014;515:563-567.
8. Fehrenbacher L, Spira A, Ballinger M, 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. Lancet. 2016;387:1837-1846.
9. Barlesi F, Park K, Ciardiello F, et al. Efficacy, safety and predictive biomarker results from OAK, a randomized phase III study comparing atezolizumab with docetaxel in patients with advanced NSCLC. Ann Oncol. 2016;27 (suppl-6):LBA44-PR.
10. Powles T, Eder JP, Fine GD, et al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 2014;27:558-562.
11. Rosenberg JE, Hoffman-Censits J, Powles T, 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. Lancet. 2016;387:1909-1920.
12. McDermott DF, Sosman JA, Sznol M, et al. Atezolizumab, an anti-programmed death-ligand 1 antibody, in metastatic renal cell carcinoma: long-term safety, clinical activity, and immune correlates from a phase Ia study. J Clin Oncol. 2016;34:833-842.
13. Emens LA, Adams S, Loi S, et al. IMpassion130: a phase III randomized trial of atezolizumab with nab-paclitaxel for first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC). J Clin Oncol. 2016;34 suppl:abstr TPS1104.
14. Petrylak DP, Powles T, Bellmunt J, et al. A phase Ia study of MPDL3280A (anti-PD-L1): updated response and survival data in urothelial bladder cancer (UBC). J Clin Oncol. 2015;33 suppl:abstr 4501.
15. FDA (website). Food and Drug Administration (FDA) 2016. Available at: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ ucm525780.htm. Accessed October 28, 2016.
16. Brown JA, Dorfman DM, Ma FR, et al. Blockade of programmed death-1 ligands on dendritic cells enhances T cell activation and cytokine production. J Immunol. 2003;170:1257-1266.
17. Reck M, Rodríguez-Abreu D, Robinson A, et al. KEYNOTE-024: pembrolizumab vs platinum-based chemotherapy as first-line therapy for advanced NSCLC with a PD-L1 TPS > 50%. Ann Oncol. 2016;27 (suppl-6):LBA8-PR.
18. Socinski M, Creelan B, Horn L, et al. CheckMate 026: a phase III trial of nivolumab vs investigator's choice of platinum-based doublet chemotherapy as first-line therapy for stage IV/recurrent programmed death ligand 1-positive NSCLC. Ann Oncol. 2016;27 (suppl-6): LBA7-PR.
19. Latchman YE, Liang SC,Wu Y, et al. PD-L1-deficient mice show that PD-L1 on T cells, antigen-presenting cells, and host tissues negatively regulates T cells. Proc Natl Acad Sci U S A. 2004;101:10691-10696.
20. Phillips T, Simmons P, Inzunza HD, et al. Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer. Appl Immunohistochem Mol Morphol. 2015;23: 541-549.
21. Horn L, Spigel DR, Gettinger SN, et al. Clinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PD-L1) in non-small cell lung cancer (NSCLC): update from a phase Ia study. J Clin Oncol. 2015;33 (suppl):abstr 8029.
22. Hirsch FR, McElhinny A, Stanforth D, et al. PD-L1 IHC assays for lung cancer: results from phase 1 of the "Blueprint PD-L1 Assay Comparison Project." AACR Annual Meeting, New Orleans. 2016.