Ipilimumab (Yervoy) and the TGN1412 catastrophe

Immunobiology

Volumn 217, Issue 6, 2012, Pages 583-589

  Bakacs, Tibor ^a   Mehrishi, Jitendra N ^b   Moss, Ralph W ^c  

^a INSTITUTE OF EXPERIMENTAL MEDICINE   (Hungary)

^b UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^c Cancer Decisions   (United States)

Author keywords

Anti CD28 monoclonal antibody; Anti CTLA 4 monoclonal antibody; Breakdown of tolerance; Ipilimumab; Regulatory T cells; TGN1412; Yervoy

Indexed keywords

B7 ANTIGEN; CD28 ANTIGEN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; IPILIMUMAB; PEPTIDE VACCINE; TGN 1412;

AUTOIMMUNE DISEASE; CANCER REGRESSION; CELL EXPANSION; CYTOKINE STORM; DRUG EFFICACY; DRUG FATALITY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERANCE; HUMAN; IMMUNE RESPONSE; IMMUNOSTIMULATION; MELANOMA; MULTIPLE CYCLE TREATMENT; MULTIPLE ORGAN FAILURE; NONHUMAN; PRIORITY JOURNAL; PROTEIN FUNCTION; RECEPTOR BLOCKING; REVIEW; RISK BENEFIT ANALYSIS; SIGNAL TRANSDUCTION; T LYMPHOCYTE ACTIVATION;

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD28; CLINICAL TRIALS, PHASE III AS TOPIC; CTLA-4 ANTIGEN; EPITOPES; HUMANS; IMMUNE TOLERANCE; IMMUNIZATION, PASSIVE; LYMPHOCYTE ACTIVATION; MELANOMA; SKIN NEOPLASMS; TREATMENT FAILURE;

EID: 84860258715     PISSN: 01712985     EISSN: 18783279     Source Type: Journal    
DOI: 10.1016/j.imbio.2011.07.005     Document Type: Review

References (47)

1. Abbas A.K., Lichtman A.H. Basic Immunology: Functions and Disorders of the Immune System 2004, Saunders, Philadelphia, PA. 2nd ed.
2. Attia P., Phan G.Q., Maker A.V., Robinson M.R., Quezado M.M., Yang J.C., 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(September (25)):6043-6053.
3. Bakacs T., Mehrishi J.N., Szabados T., Varga L., Szabo M., Tusnady G. T cells survey the stability of the self: a testable hypothesis on the homeostatic role of TCR-MHC interactions. Int. Arch. Allergy Immunol. 2007, 144(May (2)):171-182.
4. Beyersdorf N., Hanke T., Kerkau T., Hunig T. Superagonistic anti-CD28 antibodies: potent activators of regulatory T cells for the therapy of autoimmune diseases. Ann. Rheum. Dis. 2005, (November (64)):iv91-iv95. Suppl 4.
5. Bicek A., Zaletel K., Gaberscek S., Pirnat E., Krhin B., Stopar T.G., et al. 49A/G and CT60 polymorphisms of the cytotoxic T-lymphocyte-associated antigen 4 gene associated with autoimmune thyroid disease. Hum. Immunol. 2009, 70(October (10)):820-824.
6. Brand O., Gough S., Heward J. HLA CTLA-4 and PTPN22: the shared genetic master-key to autoimmunity?. Expert Rev. Mol. Med. 2005, 7(October (23)):1-15.
7. Cecchinato V., Tryniszewska E., Ma Z.M., Vaccari M., Boasso A., Tsai W.P., et al. Immune activation driven by CTLA-4 blockade augments viral replication at mucosal sites in simian immunodeficiency virus infection. J. Immunol. 2008, 180(April (8)):5439-5447.
8. Curiel T.J., Coukos G., Zou L., Alvarez X., Cheng P., Mottram P., et al. Specific recruitment of regulatory T cells in ovarian carcinoma fosters immune privilege and predicts reduced survival. Nat. Med. 2004, 10(September (9)):942-949.
9. Dallos T., Avbelj M., Barak L., Zapletalova J., Pribilincova Z., Krajcirova M., et al. CTLA-4 gene polymorphisms predispose to autoimmune endocrinopathies but not to celiac disease. Neuro. Endocrinol. Lett. 2008, 29(June (3)):334-340.
10. Daroszewski J., Pawlak E., Karabon L., Frydecka I., Jonkisz A., Slowik M., et al. Soluble CTLA-4 receptor an immunological marker of Graves' disease and severity of ophthalmopathy is associated with CTLA-4 Jo31 and CT60 gene polymorphisms. Eur. J. Endocrinol. 2009, 161(November (5)):787-793.
11. DeAngelis C.D., Fontanarosa P.B. Ensuring integrity in industry-sponsored research: primum non nocere, revisited. JAMA 2010, 303(March (12)):1196-1198.
12. Duff G, et al. Expert Scientific Group [ESG] on Phase One Clinical Trials, Interim report. http://www%20dh%20gov%20uk/assetRoot/04/13/75/69/04137569%20pdf%202006.
13. Erdmann M.K. Immunity unleashed in melanoma. Lancet Oncol. 2010, 11(February (2)):108-109.
14. Farzaneh L., Kasahara N., Farzaneh F. The strange case of TGN1412. Cancer Immunol. Immunother. 2007, 56(February (2)):129-134.
15. Hodi F.S., O'Day S.J., McDermott D.F., Weber R.W., Sosman J.A., Haanen J.B., et al. Improved survival with ipilimumab in patients with metastatic melanoma. N. Engl. J. Med. 2010, 363(August (8)):711-723.
16. Hoos A., Eggermont A.M., Janetzki S., Hodi F.S., Ibrahim R., Anderson A., et al. Improved endpoints for cancer immunotherapy trials. J. Natl. Cancer Inst. 2010, 102(September (18)):1388-1397.
17. Hwu P. Treating cancer by targeting the immune system. N. Engl. J. Med. 2010, 363(August (8)):779-781.
18. Kuo H.C., Liang C.D., Yu H.R., Wang C.L., Lin I.C., Liu C.A., et al. Ctla-4, position 49 a/g polymorphism associated with coronary artery lesions in kawasaki disease. J. Clin. Immunol. 2011, 31:240-244.
19. Lee Y.H., Harley J.B., Nath S.K. CTLA-4 polymorphisms and systemic lupus erythematosus (SLE): a meta-analysis. Hum. Genet. 2005, 116(April (5)):361-367.
20. Linsley P.S., Ledbetter J.A. The role of the CD28 receptor during T cell responses to antigen. Annu. Rev. Immunol. 1993, 11:191-212.
21. Linsley P.S., Brady W., Urnes M., Grosmaire L.S., Damle N.K., Ledbetter J.A. CTLA-4 is a second receptor for the B cell activation antigen B7. J. Exp. Med. 1991, 174(September (3)):561-569.
22. Maker A.V., Attia P., Rosenberg S.A. Analysis of the cellular mechanism of antitumor responses and autoimmunity in patients treated with CTLA-4 blockade. J. Immunol. 2005, 175(December (11)):7746-7754.
23. Maker A.V., Yang J.C., Sherry R.M., Topalian S.L., Kammula U.S., Royal R.E., et al. Intrapatient dose escalation of anti-CTLA-4 antibody in patients with metastatic melanoma. J. Immunother. 2006, 29(July (4)):455-463.
24. Marshall E., Drug trials. Violent reaction to monoclonal antibody therapy remains a mystery. Science 2006, 311(March (5768)):1688-1689.
25. Mehrishi J.N., Szabo M., Bakacs T. Some aspects of the recombinantly expressed humanised superagonist anti-CD28 mAb TGN1412 trial catastrophe lessons to safeguard mAbs and vaccine trials. Vaccine 2007, 25(May (18)):3517-3523.
26. Menard C., Ghiringhelli F., Roux S., Chaput N., Mateus C., Grohmann U., et al. Ctla-4 blockade confers lymphocyte resistance to regulatory T-cells in advanced melanoma: surrogate marker of efficacy of tremelimumab?. Clin. Cancer Res. 2008, 14(August (16)):5242-5249.
27. Morse M.A. Technology evaluation: ipilimumab Medarex/Bristol-Myers Squibb. Curr. Opin. Mol. Ther. 2005, 7(December (6)):588-597.
28. Peppercorn J.M., Smith T.J., Helft P.R., DeBono D.J., Berry S.R., Wollins D.S., et al. American society of clinical oncology statement: toward individualized care for patients with advanced cancer. J. Clin. Oncol. 2011, 29:755-760.
29. Qureshi O.S., Zheng Y., Nakamura K., Attridge K., Manzotti C., Schmidt E.M., et al. Trans-endocytosis of CD80 and CD86: a molecular basis for the cell-extrinsic function of CTLA-4. Science 2011, 332(April):600-603.
30. Read S., Malmstrom V., Powrie F. Cytotoxic T lymphocyte-associated antigen 4 plays an essential role in the function of CD25(+)CD4(+) regulatory cells that control intestinal inflammation. J. Exp. Med. 2000, 192(July (2)):295-302.
31. Robert C., Ghiringhelli F. What is the role of cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma?. Oncologist 2009, 14(August (8)):848-861.
32. Salomon B., Lenschow D.J., Rhee L., Ashourian N., Singh B., Sharpe A., et al. B7/CD28 costimulation is essential for the homeostasis of the CD4+CD25+ immunoregulatory T cells that control autoimmune diabetes. Immunity 2000, 12(April (4)):431-440.
33. Sarnaik A.A., Yu B., Yu D., Morelli D., Hall M., Bogle D., et al. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin. Cancer Res. 2011, 17(February (4)):896-906.
34. Soto P.C., Stein L.L., Hurtado-Ziola N., Hedrick S.M., Varki A. Relative over-reactivity of human versus chimpanzee lymphocytes: implications for the human diseases associated with immune activation. J. Immunol. 2010, 184(April (8)):4185-4195.
35. Suntharalingam G., Perry M.R., Ward S., Brett S.J., Castello-Cortes A., Brunner M.D., et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 2006, 355(September (10)):1018-1028.
36. Takahashi T., Tagami T., Yamazaki S., Uede T., Shimizu J., Sakaguchi N., et al. Immunologic self-tolerance maintained by CD25(+)CD4(+) regulatory T cells constitutively expressing cytotoxic T lymphocyte-associated antigen 4. J. Exp. Med. 2000, 192(July (2)):303-310.
37. Tivol E.A., Borriello F., Schweitzer A.N., Lynch W.P., Bluestone J.A., Sharpe A.H. Loss of CTLA-4 leads to massive lymphoproliferation and fatal multiorgan tissue destruction, revealing a critical negative regulatory role of CTLA-4. Immunity 1995, 3(November (5)):541-547.
38. Varki A., Altheide T.K. Comparing the human and chimpanzee genomes: searching for needles in a haystack. Genome Res. 2005, 15(December (12)):1746-1758.
39. Vitetta E.S., Ghetie V.F. Immunology. Considering therapeutic antibodies. Science 2006, 313(July (5785)):308-309.
40. Wallden J., Ilonen J., Roivainen M., Ludvigsson J., Vaarala O. Effect of HLA genotype or CTLA-4 polymorphism on cytokine response in healthy children. Scand. J. Immunol. 2008, 68(September (3)):345-350.
41. Waterhouse P., Penninger J.M., Timms E., Wakeham A., Shahinian A., Lee K.P., et al. Lymphoproliferative disorders with early lethality in mice deficient in Ctla-4. Science 1995, 270(November (5238)):985-988.
42. Weber J. Ipilimumab controversies in its development, utility and autoimmune adverse events. Cancer Immunol. Immunother. 2009, 58(May (5)):823-830.
43. Wing K., Onishi Y., Prieto-Martin P., Yamaguchi T., Miyara M., Fehervari Z., et al. CTLA-4 control over Foxp3+ regulatory T cell function. Science 2008, 322(October (5899)):271-275.
44. Wolchok J.D., 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(February (2)):155-164.
45. Wolchok J.D., Yang A.S., Weber J.S. Immune regulatory antibodies: are they the next advance?. Cancer J. 2010, 16(July (4)):311-317.
46. Woo E.Y., Chu C.S., Goletz T.J., Schlienger K., Yeh H., Coukos G., et al. Regulatory CD4(+)CD25(+) T cells in tumors from patients with early-stage non-small cell lung cancer and late-stage ovarian cancer. Cancer Res. 2001, 61(June (12)):4766-4772.
47. Zhou J., Bashey A., Zhong R., Corringham S., Messer K., Pu M., et al. CTLA-4 blockade following relapse of malignancy after allogeneic stem cell transplantation is associated with T cell activation but not with increased levels of T regulatory cells. Biol. Blood Marrow Transplant. 2011, 17(August):682-692.