Biomarkers for the clinical use of PD-1/PD-L1 inhibitors in non-small-cell lung cancer: A review

JAMA Oncology

Volumn 2, Issue 9, 2016, Pages 1217-1222

  Sacher, Adrian G ^a   Gandhi, Leena ^b,c  

^a NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATEZOLIZUMAB; CD274 PROTEIN, HUMAN; DNA DIRECTED DNA POLYMERASE ALPHA; DNA DIRECTED DNA POLYMERASE GAMMA; EGFR PROTEIN, HUMAN; EPIDERMAL GROWTH FACTOR RECEPTOR; KRAS PROTEIN, HUMAN; MONOCLONAL ANTIBODY; MSH2 PROTEIN, HUMAN; NIVOLUMAB; PDCD1 PROTEIN, HUMAN; PEMBROLIZUMAB; POLD1 PROTEIN, HUMAN; POLE PROTEIN, HUMAN; PROGRAMMED DEATH 1 LIGAND 1; PROGRAMMED DEATH 1 RECEPTOR; PROTEIN MSH2; PROTEIN P21; TUMOR MARKER;

ADENOCARCINOMA; ANTAGONISTS AND INHIBITORS; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; GENETICS; HUMAN; LUNG NEOPLASMS; METABOLISM; MUTATION; PROGNOSIS;

ADENOCARCINOMA; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD274; BIOMARKERS, TUMOR; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; DNA POLYMERASE II; DNA POLYMERASE III; HUMANS; LUNG NEOPLASMS; MUTATION; MUTS HOMOLOG 2 PROTEIN; PROGNOSIS; PROGRAMMED CELL DEATH 1 RECEPTOR; PROTO-ONCOGENE PROTEINS P21(RAS); RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 85010653023     PISSN: 23742437     EISSN: 23742445     Source Type: Journal    
DOI: 10.1001/jamaoncol.2016.0639     Document Type: Review

References (43)

1. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015; 373 (17): 1627-1639.
2. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015; 373 (2): 123-135.
3. Garon EB, Rizvi NA, Hui R, et al; KEYNOTE-001 Investigators. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015; 372 (21): 2018-2028.
4. Rizvi NA, Mazières J, Planchard D, et al. 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. 2015; 16(3): 257-265.
5. Velcheti V, Schalper KA, Carvajal DE, et al. Programmed death ligand-1 expression in non-small cell lung cancer. Lab Invest. 2014; 94(1): 107-116.
6. Yang CY, LinMW, Chang YL,Wu CT, Yang PC. Programmed cell death-ligand 1 expression in surgically resected stage I pulmonary adenocarcinoma and its correlation with driver mutations and clinical outcomes. Eur J Cancer. 2014; 50(7): 1361-1369.
7. Chen YB, Mu CY, Huang JA. Clinical significance of programmed death-1 ligand-1 expression in patients with non-small cell lung cancer: A 5-year-follow-up study. Tumori. 2012; 98(6): 751-755.
8. Chen YY,Wang LB, Zhu HL, et al. Relationship between programmeddeath-ligand 1 and clinicopathological characteristics in non-small cell lung cancer patients. Chin Med Sci J. 2013; 28(3): 147-151.
9. Mu CY, Huang JA, Chen Y, Chen C, Zhang XG. High expression of PD-L1 in lung cancer may contribute to poor prognosis and tumor cells immune escape through suppressing tumor infiltrating dendritic cells maturation. Med Oncol. 2011; 28(3): 682-688.
10. Tokito T, Azuma K, Kawahara A, et al. Predictive relevance of PD-L1 expression combined with CD8+ TIL density in stage III non-small cell lung cancer patients receiving concurrent chemoradiotherapy. Eur J Cancer. 2016; 55: 7-14.
11. Zhong A, Xing Y, Pan X, Shi M, Xu H. Prognostic value of programmed cell death-ligand 1 expression in patients with non-small-cell lung cancer: Evidence from an updated meta-analysis. Onco Targets Ther. 2015; 8: 3595-3601.
12. Schmidt LH, Kümmel A, Görlich D, et al. PD-1 and PD-L1 Expression in NSCLC Indicate a Favorable Prognosis in Defined Subgroups. PLoS One. 2015; 10(8): E0136023.
13. Taube JM, Klein A, Brahmer JR, et al. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-PD-1 therapy. Clin Cancer Res. 2014; 20(19): 5064-5074.
14. Taube JM, Anders RA, Young GD, et al. Colocalization of inflammatory response with B7-h1 expression in human melanocytic lesions supports an adaptive resistance mechanism of immune escape. Sci Transl Med. 2012; 4(127): 127ra37.
15. Dong H, Strome SE, Salomao DR, et al. Tumor-associated B7-H1 promotes T-cell apoptosis: A potential mechanism of immune evasion. Nat Med. 2002; 8(8): 793-800.
16. Rozali EN, Hato SV, Robinson BW, Lake RA, LesterhuisWJ. Programmed death ligand 2 in cancer-induced immune suppression. Clin Dev Immunol. 2012; 2012: 656340.
17. 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(7528): 563-567.
18. McLaughlin J, Han G, Schalper KA, et al. Quantitative Assessment of the Heterogeneity of PD-L1 Expression in Non-Small-Cell Lung Cancer. JAMA Oncol. 2016; 2(1): 46-54.
19. Gettinger SN, Horn L, Gandhi L, et al. Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2015; 33(18): 2004-2012.
20. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.NEngl J Med. 2012; 366(26): 2443-2454.
21. Galvano A. PD-L1 expression as predictive biomarker in patients with NSCLC: A pooled analysis. IASLCWorld Conference on Lung Cancer; 2015; Denver, CO.
22. FDA approves Keytruda for advanced non-small-cell lung cancer [press release, October 2, 2015]. http: //www.fda.gov/newsevents /newsroom/pressannouncements/ucm465444 .htm. Accessed May 13, 2016.
23. FDA expands approved use of Opdivo in advanced lung cancer [press release, October 9, 2015]. http: //www.fda.gov/NewsEvents/Newsroom /PressAnnouncements/ucm466413.htm. Accessed May 13, 2016.
24. Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (Keynote-010): A randomised controlled trial. Lancet. 2016; 387(10027): 1540-1550.
25. Spira A, Park K, Mazieres J, et al. Efficacy, safety and predictive biomarker results from a randomized phase II study comparing MPDL3280A vs docetaxel in 2L/3L NSCLC (POPLAR). American Society of Clinical Oncology (ASCO) Annual Meeting; 2015; Chicago, IL.
26. Brahmer JR, Rizvi NA, Lutzky J, Khleif S. Clinical activity and biomarkers of MEDI4736, an anti-PD-L1 antibody, in patients with NSCLC. ASCO Annual Meeting; 2014; Chicago, IL.
27. Rebelatto M, Mistry A, Sabalos C, et al. Development of a PD-L1 companion diagnostic assay for treatment with MEDI4736 in NSCLC andSCCHNpatients. American Society of Clinical Oncology (ASCO) Annual Meeting; 2015; Chicago, IL.
28. Garon EB. Current Perspectives in Immunotherapy for Non-Small Cell Lung Cancer. Semin Oncol. 2015; 42(suppl 2): S11-S18.
29. Hansen AR, Siu LL. PD-L1 Testing in Cancer: Challenges in Companion Diagnostic Development. JAMA Oncol. 2016; 2(1): 15-16.
30. Ballinger TJ, Sanders ME, Abramson VG. Current HER2 testing recommendations and clinical relevance as a predictor of response to targeted therapy. Clin Breast Cancer. 2015; 15(3): 171-180.
31. Paez JG, Jänne PA, Lee JC, et al. EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science. 2004; 304 (5676): 1497-1500.
32. Rizvi NA, Hellmann MD, Snyder A, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015; 348(6230): 124-128.
33. Snyder A, Makarov V, Merghoub T, et al. Genetic basis for clinical response to CTLA-4 blockade in melanoma.NEngl J Med. 2014; 371(23): 2189-2199.
34. Van Allen EM, Miao D, Schilling B, et al. Genomic correlates of response to CTLA-4 blockade inmetastatic melanoma. Science. 2015; 350(6257): 207-211.
35. Le DT, Uram JN,Wang H, et al. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med. 2015; 372(26): 2509-2520.
36. Hellmann M, Garon E, Gandhi L, et al. Efficacy of pembrolizumab in key subgroups of patients with advanced squamous or non-squamous non-small-cell lung cancer. IASLCWorld Conference on Lung Cancer; 2015; Denver, CO.
37. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma.NEngl J Med. 2015; 373(1): 23-34.
38. Patnaik A, Socinski M, Gubens M. Phase I study of pembrolizumab plus ipilimumab as second-line therapy for advanced NSCLC: KEYNOTE-021 cohort D. American Society of Clinical Oncology Annual Meeting; 2015; Chicago, IL.
39. Antonia S, Gettinger S, Chow L. Nivolumab and ipilimumab in first-line NSCLC: Interim phase I results. American Society of Clinical Oncology Annual Meeting; 2015; Chicago, IL.
40. Rizvi N, Gettinger S, Goldman J, et al. Safety and efficacy of first-line nivolumab and ipilimumab in non-small cell lung cancer. IASLCWorld Conference on Lung Cancer; 2015; Denver, CO.
41. Antonia S, Goldberg S, Balmanoukian A, et al. Phase Ib study of MEDI4736, a programmedcell death ligand-1 (PD-L1) antibody, in combination with tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) antibody, in patients (pts) with advanced NSCLC. American Society of Clinical Oncology Annual Meeting; 2015; Chicago, IL.
42. Jänne PA, Yang JC, Kim DW, et al. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015; 372(18): 1689-1699.
43. Sacher AG, Jänne PA, Oxnard GR. Management of acquired resistance to epidermal growth factor receptor kinase inhibitors in patients with advanced non-small cell lung cancer. Cancer. 2014; 120(15): 2289-2298.