Anti-CTLA4 monoclonal antibody ipilimumab in the treatment of metastatic melanoma: Recent findings

Recent Patents on Anti-Cancer Drug Discovery

Volumn 3, Issue 2, 2008, Pages 105-113

  Lens, Marko ^a   Ferrucci, Pier F ^b   Testori, Alessandro ^b  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

Author keywords

Anti tumour; Antibody; CTLA 4; Ipilimumab; Melanoma

Indexed keywords

ALPHA2B INTERFERON; ANTIHISTAMINIC AGENT; ANTINEOPLASTIC AGENT; B7 ANTIGEN; BUDESONIDE; CARBOPLATIN; CD28 ANTIGEN; CD4 ANTIGEN; CD45RO ANTIGEN; CD86 ANTIGEN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4 ANTIBODY; DACARBAZINE; DNA VACCINE; EMOLLIENT AGENT; FOTEMUSTINE; INFLIXIMAB; INTERLEUKIN 2; IPILIMUMAB; MELANOMA VACCINE; MELPHALAN; PACLITAXEL; PLACEBO; STEROID; T LYMPHOCYTE RECEPTOR; TEMOZOLOMIDE; TESTOSTERONE; THYROID HORMONE; TICILIMUMAB; UNINDEXED DRUG;

ADJUVANT THERAPY; ANTINEOPLASTIC ACTIVITY; ARTHRITIS; AUTOIMMUNE DISEASE; CANCER ADJUVANT THERAPY; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DERMATITIS; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ENTEROCOLITIS; HUMAN; HYPOPHYSITIS; IMMUNOLOGICAL TOLERANCE; LOW DRUG DOSE; MELANOMA; METASTASIS; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NONHUMAN; NUCLEOTIDE SEQUENCE; PRIORITY JOURNAL; PROSTATE CANCER; PROSTATECTOMY; REVIEW; SINGLE DRUG DOSE; TOXIC HEPATITIS; TUMOR IMMUNITY; UNSPECIFIED SIDE EFFECT; UVEITIS;

ANTIBODIES, MONOCLONAL; ANTIGENS, CD; CLINICAL TRIALS AS TOPIC; HLA-A ANTIGENS; HUMANS; MELANOMA;

EID: 53749087081     PISSN: 15748928     EISSN: None     Source Type: Journal    
DOI: 10.2174/157489208784638767     Document Type: Review

References (67)

1. Gimotty PA, Botbyl J, Soong S, Guerry D. A population-based validation of the American Joint Committee on Cancer melanoma staging system. J Clin Oncol 2005; 23(31): 8065-8075.
2. McKinnon JG, Yu XQ, McCarthy WH, Thompson JF. Prognosis for patients with thin cutaneous melanoma: long-term survival data from New South Wales Central Cancer Registry and the Sydney Melanoma Unit. Cancer 2003; 98(6): 1223-1231.
3. Tarhini AA, Agarwala SS. Cutaneous melanoma: available therapy for metastatic disease. Dermatol Ther 2006; 19(1): 19-25.
4. Riker AI, Radfar S, Liu S, Wang Y, Khong HT. Immunotherapy of melanoma: a critical review of current concepts and future strategies. Expert Opin Biol Ther 2007; 7(3): 345-58. [PMID: 17309326]
5. Lens M, Eisen T. Systemic chemotherapy in the treatment of malignant melanoma. Expert Opin Pharmacother 2003; 4(12): 2205-2211.
6. Gogas HJ, Kirkwood JM, Sondak VK. Chemotherapy for metastatic melanoma: time for a change? Cancer 2007; 109(3): 455-464 7 Flaherty KT. Chemotherapy and targeted therapy combinations in advanced melanoma. Clin Cancer Res 2006; 12(7 Pt 2): 2366-2370.
7. Kasper B, D'Hondt V, Vereecken P, Awada A. Novel treatment strategies for malignant melanoma: a new beginning? Crit Rev Oncol Hematol 2007; 62(1): 16-22.
8. Burnet FM. Cancer: a biological approach. BMJ 1957; 1: 779-786; 841-847.
9. Swann JB, Smyth MJ. Immune surveillance of tumors. J Clin Invest 2007; 117: 1137-1146.
10. Dunn GP, Bruce AT, Ikeda H, Old LJ, Schreiber RD. Cancer immunoediting: from immunosurveillance to tumor escape. Nat Immunol 2002; 3: 991-998.
11. Dunn GP, Old LJ, Schreiber RD. The three Es of cancer immunoediting. Annu Rev Immunol 2004; 22: 329-360.
12. Parmiani G, Castelli C, Rivoltini L, et al. Immunotherapy of melanoma. Semin Cancer Biol 2003; 13(6): 391-400.
13. Jack A, Boyes C, Aydin N, Alam K, Wallack M. The treatment of melanoma with an emphasis on immunotherapeutic strategies. Surg Oncol 2006; 15(1): 13-24.
14. Monsurro V, Wang E, Panelli MC, et al. Active-specific immunization against melanoma: is the problem at the receiving end? Semin Cancer Biol 2003; 13(6): 473-480.
15. Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science 1996; 271: 1734-1736.
16. Chambers CA, Kuhns MS, Egen JG, Allison JP. CTLA-4-mediated inhibition in regulation of T cell responses: mechanisms and manipulation in tumor immunotherapy. Annu Rev Immunol 2001; 19: 565-594.
17. Fischkoff, S., Lowy, I., Yellin, M., Yang, J.C.: US20070248595A1 ( 2007).
18. Sharpe AH, Freeman GJ. The B7-CD28 superfamily. Nat Rev Immunol 2002; 2(2): 116-26.
19. Greenwald RJ, Latchman YE, Sharpe AH. Negative co-receptors on lymphocytes. Curr Opin Immunol 2002; 14(3): 391-396.
20. Van der Merwe PA, Bodian DL, Daenke S, Linsley P, Davis SJ. CD80 (B7-1) binds both CD28 and CTLA-4 with a low affinity and very fast kinetics. J Exp Med 1997; 185(3): 393-403.
21. Cranmer LD, Hersh E. The role of the CTFLA4 blockade in the treatment of malignant melanoma. Cancer Invest 2007; 25(7): 613-31. [PMID: 18027152]
22. Perez VL, Van Parjis L, Biuckians A, Zhang XX, Strom TB, Abbas AK. Induction of peripheral T cell tolerance in vivo requires CTLA-4 engagement. Immunity 1997; 6: 411-417.
23. Lee KM, Chuang E, Griffin M, et al. Molecular basis of T cell inactivation by CTLA-4. Science 1998; 282: 2263-2266. [PMID: 9856951]
24. Brunner M, Chambers C, Allison J. CTLA-4-Mediated inhibition of early events of T cell proliferation. J Immunol 1999; 162(10): 5813-5820.
25. Caton AJ, Cozzo C, Larkin J 3rd, Lerman MA, Boesteanu A, Jordan MS. CD4(+) CD25(+) regulatory T cell selection. Ann N Y Acad Sci 2004; 1029: 101-114.
26. Hodi FS. Cytotoxic T-lymphocyte-associated antigen-4. Clin Cancer Res 2007; 13(18): 5238-5242.
27. Chambers CA, Allison JP. Co-stimulation in T cell response. Curr Opin Immunol 1997; 9: 396-404.
28. Waterhouse P, Penninger JM, Timms E, et al. Lymphoproliferative disorders with early lethality in mice deficient in CTLA-4. Science 1995; 270: 985-988.
29. Tivol EA, Borriello F, Schweitzer AN, Lynch WP, Bluestone JA, Sharpe AH. 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: 541-547.
30. Kwon, ED, Hurwitz AA, Foster BA, et al. Manipulation of T cell costimulatory and inhibitory signals for immunotherapy of prostate cancer. Proc Natl Acad Sci USA 1997; 94(15): 8099-8103.
31. Kwon ED, Foster BA, Hurwitz AA, et al. Elimination of residual metastatic prostate cancer after surgery and adjunctive cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) blockade immunotherapy. Proc Natl Acad Sci USA 1999; 96(260): 15074-15079.
32. Egen JG, Kuhns MS, Allison JP. CTLA-4: New insights into its biological function and use in tumor immunotherapy. Nat Immunol 2002; 3: 611-618.
33. Mokyr MB, Kalinichenko T, Gorelik L, Bluestone JA. Realization of the therapeutic potential of CTLA-4 blockade in low-dose chemotherapy-treated tumor-bearing mice. Cancer Res 1998; 58(23): 5301-5304.
34. van Elsas A, Hurwitz AA, Allison JP. Combination immunotherapy of B16 melanoma using anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and granulocyte/macrophage colony-stimulating factor (GM-CSF)-producing vaccines induces rejection of subcutaneous and metastatic tumors accompanied by autoimmune depigmentation. J Exp Med 1999; 190(3): 355-366.
35. Hurwitz AA, Foster BA, Kwon ED, et al. Combination immunotherapy of primary prostate cancer in a transgenic mouse model using CTLA-4 blockade. Cancer Res 2000; 60: 2444-2448.
36. Gregor PD, Wolchok JD, Ferrone CR, et al. CTLA-4 blockade in combination with xenogeneic DNA vaccines enhances T-cell responses, tumor immunity and autoimmunity to self antigens in animal and cellular model systems. Vaccine 2004; 22(13-14: 1700-1708.
37. Weber J. Review: anti-CTLA-4 antibody ipilimumab: case studies of clinical response and immune-related adverse events. Oncologist 2007; 12(7): 864-872.
38. Tchekmedyian S, Glasby JA, Korman A, Keler T, Deo Y, Davis T. MDX-010 (human anti-CTLA4): A phase I trial in malignant melanoma. 2002 ASCO annual Meeting, Abstract #56.
39. Hodi FS, Mihm MC, Soiffer RJ, 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.
40. Sanderson K, Scotland R, Lee P, et al. Autoimmunity in a phase I trial of a fully human anti-cytotoxic T-lymphocyte antigen-4 monoclonal antibody with multiple melanoma peptides and Montanide ISA 51 for patients with resected stages III and IV melanoma. J Clin Oncol 2005; 23(4): 741-750.
41. Weber JS, Targan S, Scotland R, et al. Phase II trial of extended dose anti-CTLA-4 antibody ipilimumab (formerly MDX-010) with a multi-peptide vaccine for resected stages IIIC and IV melanoma. 2006 ASCO Annual Meeting, Abstract #2510.
42. Weber JS. The clinical utility of cytotoxic T lymphocyte antigen 4 abrogation by human antibodies. Melanoma Res 2006; 16(5): 379-383.
43. Phan GQ, Yang JC, Sherry RM, 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: 8372-8837.
44. Attia P, Phan GQ, Maker AV, et al. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anticytotoxic T-lymphocyte antigen-4. J Clin Oncol 2005; 23: 6043-6053.
45. Maker AV, Yang JC, Sherry RM, et al. Intrapatient dose escalation of anti-CTLA-4 antibody in patients with metastatic melanoma. J Immunother (1997) 2006; 29(4): 455-463.
46. Downey SG, Klapper JA, Smith FO, et al. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res 2007; 13(22): 6681-6688.
47. Weber JS, Hersh EM, Yellin M, et al. The efficacy and safety of ipilimumab (MDX-010) in patients with unresectable stage III or stage IV malignant melanoma. 2007 ASCO Annual Meeting, Abstract #8523
48. Maker AV, Phan GQ, Attia P, et al. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: a phase I/II study. Ann Surg Oncol 2005; 12(12): 1005-1016.
49. Schwartzentruber DJ. Guidelines for the safe administration of high-dose interleukin-2. J Immunother (1997) 2001; 24(4): 287-293.
50. Hersh EM, Weber J, Powderly J, et al. A phase III, randomized multi-center study of MDX-010 alone or in combination with dacarbazine (DTIC) in stage IV metastatic malignant melanoma. 2004 ASCO Annual Meeting, Abstract #7511
51. Fischkoff SA, Hersh E, Weber J, et al. Durable responses and long-term progression-free survival observed in a phase II study of MDX-010 alone or in combination with dacarbazine (DTIC) in metastatic melanoma. 2005 ASCO Annual Meeting, Abstract #7525
52. Hamid O, Urba WJ, Yellin M, et al. Kinetics of response to ipilimumab (MDX-010) in patients with stage III/IV melanoma. 2007 ASCO Annual Meeting, Abstract #8525
53. Saenger YM, Wolchok JD. The heterogeneity of the kinetics of response to ipilimumab in metastatic melanoma: patient cases. Cancer Immun 2008; 8: 1.
54. O'Day SJ, Hamid O, Urba WJ. Targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4): a novel strategy for the treatment of melanoma and other malignancies. Cancer 2007; 110(12): 2614-27.
55. Vijayakrishnan L, Slavik JM, Illés Z, et al. An autoimmune disease-associated CTLA4 splice variant lacking the B7 binding domain signals negatively in T cells. Novartis Found Symp 2005; 267: 200-218.
56. Ueda H, Howson JM, Esposito L, et al. Association of the T-cell regulatory gene CTLA4 with susceptibility to autoimmune disease. Nature 2003; 423(6939): 506-511.
57. Beck KE, Blansfield JA, Tran KQ, et al. Enterocolitis in patients with cancer after antibody blockade of cytotoxic T-lympocyte-associated antigen 4. J Clin Oncol 2006; 24(15): 2283-2289.
58. Fischkoff, S, Lowy, I., Targan, S., Yang J.C.: US20070243184A1 (2007).
59. Jaber SH, Cowen EW, Haworth LR, et al. Skin reactions in a subset of patients with stage IV melanoma treated with anti-cytotoxic T-lymphocyte antigen 4 monoclonal antibody as a single agent. Arch Dermatol 2006; 142(2): 166-172.
60. Blansfield JA, Beck KE, Tran K, et al. Cytotoxic T-lymphocyte-associated antigen-4 blockage can induce autoimmune hypophysitis in patients with metastatic melanoma and renal cancer. J Immunother 2005; 28(6): 593-598.
61. ClinicalTrials.gov Bethesda (MD): National Library of Medicine (US); 2000; [cited March 1, 2008]. NLM Identifier: NCT 00261365. URL: http://clinicaltrials.gov/show/NCT00261365.
62. ClinicalTrials.gov Bethesda (MD): National Library of Medicine (US); 2000; [cited March 1, 2008]. NLM Identifier: NCT 00135408. URL: http://clinicaltrials.gov/show/NCT00135408.
63. ClinicalTrials.gov Bethesda (MD): National Library of Medicine (US); 2000; [cited March 1, 2008]. NLM Identifier: NCT 00289627. URL: http://clinicaltrials.gov/show/NCT00289627.
64. ClinicalTrials.gov Bethesda (MD): National Library of Medicine (US); 2000; [cited March 1, 2008]. NLM Identifier: NCT 00289640. URL: http://clinicaltrials.gov/show/NCT00289640.
65. ClinicalTrials.gov Bethesda (MD): National Library of Medicine (US); 2000; [cited March 1, 2008]. NLM Identifier: NCT0077532. URL: http://clinicaltrials.gov/show/NCT0077532.
66. ClinicalTrials.gov Bethesda (MD): National Library of Medicine (US); 2000; [cited March 1, 2008]. NLM Identifier: NCT 00162123. URL: http://clinicaltrials.gov/show/NCT00162123.
67. ClinicalTrials.gov Bethesda (MD): National Library of Medicine (US); 2000; [cited March 1, 2008]. NLM Identifier: NCT 00324155. URL: http://clinicaltrials.gov/show/NCT00324155.