1. Starnes CO. Coley's toxins in perspective. Nature. 1992; 357:11–12.
Article
2. Vesely MD, Kershaw MH, Schreiber RD, Smyth MJ. Natural innate and adaptive immunity to cancer. Annu Rev Immunol. 2011; 29:235–271. doi: 10. 1146/annurev-immunol-031210-101324.
Article
3. Thaxton JE, Li Z. To affinity and beyond: harnessing the T cell receptor for cancer immunotherapy. Hum Vaccin Immunother. 2014; 10:3313–3321. doi: 10.4161/21645515.2014.973314.
Article
4. Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014; 515:568–571. doi: 10.1038/nature13954.
Article
5. Fridman WH, Pagès F, Sautès-Fridman C, Galon J. The immune contexture in human tumours: impact on clinical outcome. Nat Rev Cancer. 2012; 12:298–306. doi: 10.1038/nrc3245.
Article
6. Galon J, Costes A, Sanchez-Cabo F, Kirilovsky A, Mlecnik B, Lagorce-Pagès C, et al. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006; 313:1960–1964.
Article
7. Erdag G, Schaefer JT, Smolkin ME, Deacon DH, Shea SM, Dengel LT, et al. Immunotype and immunohistologic characteristics of tumor-infiltrating immune cells are associated with clinical outcome in metastatic melanoma. Cancer Res. 2012; 72:1070–1080. doi: 10.1158/0008-5472.CAN-11-32 18.
Article
8. Mlecnik B, Tosolini M, Kirilovsky A, Berger A, Bindea G, Meatchi T, et al. Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction. J Clin Oncol. 2011; 29:610–618. doi: 10.1200/JCO.2010.30.5425.
Article
9. Mihm MC Jr, Mulé JJ. Reflections on the Histopathology of Tumor-Infiltrating Lymphocytes in Melanoma and the Host Immune Response. Cancer Immunol Res. 2015; 3:827–835. doi: 10.1158/2326-6066.CIR-15-0143.
Article
10. Ahn SG, Jeong J, Hong S, Jung WH. Current Issues and Clinical Evidence in Tumor-Infiltrating Lymphocytes in Breast Cancer. J Pathol Transl Med. 2015; 49:355–363. doi: 10.4132/jptm.2015.07.29.
Article
11. Dahlin AM, Henriksson ML, Van Guelpen B, Stenling R, Oberg A, Rutegård J, et al. Colorectal cancer prognosis depends on T-cell infiltration and molecular characteristics of the tumor. Mod Pathol. 2011; 24:671–682. doi: 10.1038/modpathol.2010.234.
Article
12. Beard RE, Abate-Daga D, Rosati SF, Zheng Z, Wunderlich JR, Rosenberg SA, et al. Gene expression profiling using nanostring digital RNA counting to identify potential target antigens for melanoma immunotherapy. Clin Cancer Res. 2013; 19:4941–4950. doi: 10.1158/1078-0432.CCR-13-1253.
Article
13. Ascierto PA, Capone M, Urba WJ, Bifulco CB, Botti G, Lugli A, et al. The additional facet of immunoscore: immunoprofiling as a possible predictive tool for cancer treatment. J Transl Med. 2013; 11:54. doi: 10.1186/1479-58 76-11-54.
Article
14. Ogino S, Nosho K, Irahara N, Meyerhardt JA, Baba Y, Shima K, et al. Lymphocytic reaction to colorectal cancer is associated with longer survival, independent of lymph node count, microsatellite instability, and CpG island methylator phenotype. Clin Cancer Res. 2009; 15:6412–6420. doi: 10.1158/1078-0432.CCR-09-1438.
Article
15. Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, et al. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med. 2015; 372:2509–2520. doi: 10.1056/NEJMoa1500596.
16. Supek F, Lehner B. Differential DNA mismatch repair underlies mutation rate variation across the human genome. Nature. 2015; 521:81–84. doi: 10. 1038/nature14173.
Article
17. Alexandrov LB, Nik-Zainal S, Wedge DC, Aparicio SA, Behjati S, Biankin AV, et al. Signatures of mutational processes in human cancer. Nature. 2013; 500:415–421. doi: 10.1038/nature12477.
18. Zha Y, Spranger S, Hernandez KM, Li Y, Bao R, Alexieff P, et al. Density of immunogenic antigens does not explain presence or absence of the T cell-inflamed tumor microenvironment in metastatic melanoma. J Immunother Cancer. 2015; 3(Suppl 2):): p. 425.
Article
19. Wang C, Thudium KB, Han M, Wang XT, Huang H, Feingersh D, et al. In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in non-human primates. Cancer Immunol Res. 2014; 2:846–856. doi: 10.1158/2326-6066.CIR-14-0040.
Article
20. Parsa AT, Waldron JS, Panner A, Crane CA, Parney IF, Barry JJ, et al. Loss of tumor suppressor PTEN function increases B7-H1 expression and immunoresistance in glioma. Nat Med. 2007; 13:84–88.
Article
21. Atefi M, Avramis E, Lassen A, Wong DJ, Robert L, Foulad D, et al. Effects of MAPK and PI3K pathways on PD-L1 expression in melanoma. Clin Cancer Res. 2014; 20:3446–3457. doi: 10.1158/1078-0432.CCR-13-2797.
Article
22. Taube JM, Klein A, Brahmer JR, Xu H, Pan X, Kim JH, 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; 20:5064–5074. doi: 10.1158/1078-0432.CCR-13-3271.
Article
23. Teng MW, Ngiow SF, Ribas A, Smyth MJ. Classifying Cancers Based on T-cell Infiltration and PD-L1. Cancer Res. 2015; 75:2139–2145. doi: 10.11 58/0008-5472.CAN-15-0255.
Article
24. Velcheti V, Schalper KA, Carvajal DE, Anagnostou VK, Syrigos KN, Sznol M, et al. Programmed death ligand-1 expression in non-small cell lung cancer. Lab Invest. 2014; 94:107–116. doi: 10.1038/labinvest.2013.130.
Article
25. Champiat S, Ileana E, Giaccone G, Besse B, Mountzios G, Eggermont A, et al. Incorporating immune-checkpoint inhibitors into systemic therapy of NSCLC. J Thorac Oncol. 2014; 9:144–153. doi: 10.1097/JTO.000000000000 0074.
Article
26. Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med. 2013; 369:134–144. doi: 10.1056/NEJMoa1305133.
Article
27. Ji RR, Chasalow SD, Wang L, Hamid O, Schmidt H, Cogswell J, et al. An immune-active tumor microenvironment favors clinical response to ipilimumab. Cancer Immunol Immunother. 2012; 61:1019–1031. doi: 10.1007/s00262-011-1172-6.
Article
28. Hodi FS, Mihm MC, Soiffer RJ, Haluska FG, Butler M, Seiden MV, et al. Biologic activity of cytotoxic T lymphocyte-associated antigen 4 antibody blockade in previously vaccinated metastatic melanoma and ovarian carcinoma patients. Proc Natl Acad Sci USA. 2003; 100:4712–4717.
Article
29. Phan GQ, Yang JC, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, et al. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci USA. 2003; 100:8372–8377.
Article
30. Weber JS, O'Day S, Urba W, Powderly J, Nichol G, Yellin M, et al. Phase I/II study of ipilimumab for patients with metastatic melanoma. J Clin Oncol. 2008; 26:5950–5956. doi: 10.1200/JCO.2008.16.1927.
Article
31. Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010; 11:155–164. doi: 10.1016/S1470-2045 (09)70334-1.
Article
32. Feng Y, Masson E, Dai D, Parker SM, Berman D, Roy A. Model-based clinical pharmacology profiling of ipilimumab in patients with advanced melanoma. Br J Clin Pharmacol. 2014; 78:106–117. doi: 10.1111/bcp.12323.
Article
33. Glassman PM, Balthasar JP. Mechanistic considerations for the use of monoclonal antibodies for cancer therapy. Cancer Biol Med. 2014; 11:20–33. doi: 10.7497/j.issn.2095-3941.2014.01.002.
34. Feng Y, Roy A, Masson E, Chen TT, Humphrey R, Weber JS. Exposure-response relationships of the efficacy and safety of ipilimumab in patients with advanced melanoma. Clin Cancer Res. 2013; 19:3977–3986. doi: 10.1158/1078-0432.CCR-12-3243.
Article
35. Simpson TR, Li F, Montalvo-Ortiz W, Sepulveda MA, Bergerhoff K, Arce F, et al. Fc-dependent depletion of tumor-infiltrating regulatory T cells co-defines the efficacy of anti-CTLA-4 therapy against melanoma. J Exp Med. 2013; 210:1695–1710. doi: 10.1084/jem.20130579.
Article
36. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012; 366:2443–2454. doi: 10.1056/NEJMoa12006 90.
Article
37. Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015; 373:1803–1813. doi: 10.1056/NEJMoa1510665.
Article
38. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015; 373:1627–1639. doi: 10.1056/NEJ-Moa1507643.
Article
39. Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015; 372:320–330. doi: 10.1056/NEJMoa1412082.
40. Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015; 16:908–918. doi: 10.1016/S1470-2045 (15)00083-2.
41. Gangadhar TC, Mehnert J, Patnaik A, Hamid O, Carlino MS, Hodi FS, et al. Population pharmacokinetic (popPK) model of pembrolizumab (pem-bro; MK-3475) in patients (pts) treated in KEYNOTE-001 and KEY-NOTE-002. J Clin Oncol. 2015. 33.
Article
42. Elassaiss-Schaap J, Lindauer A, Sostelly A, Ahamadi M, Gergich K, Kang P, et al. Modeling of tumor size reduction patterns in advanced melanoma under treatment with MK-3475, a potent antibody against PD-1. PAGE 23. 2014. ;Abstr 3213.
43. Kleffel S, Posch C, Barthel SR, Mueller H, Schlapbach C, Guenova E, et al. Melanoma Cell-Intrinsic PD-1 Receptor Functions Promote Tumor Growth. Cell. 2015; 162:1242–1256. doi: 10.1016/j.cell.2015.08.052.
Article
44. Waterhouse P, Penninger JM, Timms E, Wakeham A, Shahinian A, Lee KP, et al. Lymphoproliferative disorders with early lethality in mice deficient in Ctla-4. Science. 1995; 270:985–988.
45. Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science. 1996; 271:1734–1736.
Article
46. van Elsas A, Sutmuller RP, Hurwitz AA, Ziskin J, Villasenor J, Medema JP, et al. Elucidating the autoimmune and antitumor effector mechanisms of a treatment based on cytotoxic T lymphocyte antigen-4 blockade in combination with a B16 melanoma vaccine: comparison of prophylaxis and therapy. J Exp Med. 2001; 194:481–489.
47. Bertrand A, Kostine M, Barnetche T, Truchetet ME, Schaeverbeke T. Immune related adverse events associated with anti-CTLA-4 antibodies: systematic review and metaanalysis. BMC Med. 2015; 13:211. doi: 10.1186/s12916-015-0455-8.
Article
48. Beck KE, Blansfield JA, Tran KQ, Feldman AL, Hughes MS, Royal RE, et al. Enterocolitis in patients with cancer after antibody blockade of cytotoxic T-lymphocyte-associated antigen 4. J Clin Oncol. 2006; 24:2283–2289.
Article
49. Attia P, Phan GQ, Maker AV, Robinson MR, Quezado MM, Yang JC, et al. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol. 2005; 23:6043–6053.
Article
50. Weber J, Thompson JA, Hamid O, Minor D, Amin A, Ron I, et al. A randomized, double-blind, placebocontrolled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res. 2009; 15:5591–5598. doi: 10.1158/1078-0432.CCR-09-1024.
Article
51. Weber JS, Antonia SJ, Topalian SL, Schadendorf D, Larkin JMG, Sznol M, et al. Safety profile of nivolumab (NIVO) in patients (pts) with advanced melanoma (MEL): A pooled analysis. J Clin Oncol. 2015; 33:(suppl;abstr 9018):
Article
52. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009; 45:228–247. doi: 10.1016/j.ejca. 2008.10.026.
Article
53. Atkins MB. Cytokine-based therapy and biochemotherapy for advanced melanoma. Clin Cancer Res. 2006; 12:2353s–2358s.
Article
54. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010; 363:711–723. doi: 10.1056/NEJMoa1003466.
Article