Profile of ipilimumab and its role in the treatment of metastatic Melanoma

Drug Design, Development and Therapy

Volumn 5, Issue , 2011, Pages 489-495

  Patel, Sapna P ^a   Woodman, Scott E ^a  

^a UNIVERSITY OF TEXAS   (United States)

Author keywords

CTLA 4; Ipilimumab; Melanoma; T cells

Indexed keywords

CORTICOSTEROID; DACARBAZINE; GLYCOPROTEIN GP 100; IPILIMUMAB; METHYLPREDNISOLONE; PLACEBO; PREDNISONE;

BULLOUS DERMATITIS; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; DERMATITIS; DISEASE ASSOCIATION; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG FATALITY; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENTEROCOLITIS; FEVER; GASTROINTESTINAL SYMPTOM; HEPATITIS; HUMAN; HYPOPHYSITIS; ILEUS; IMMUNE RESPONSE; INTERMETHOD COMPARISON; INTESTINE PERFORATION; LIVER FAILURE; MELANOMA; METASTASIS; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NECROSIS; NONHUMAN; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; REVIEW; SKIN EXFOLIATION; STEVENS JOHNSON SYNDROME; SYNDROME DELINEATION; TOXIC EPIDERMAL NECROLYSIS; ULCER; UVEITIS;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; EVIDENCE-BASED MEDICINE; HUMANS; MELANOMA; SKIN NEOPLASMS; TREATMENT OUTCOME;

EID: 84859145034     PISSN: 11778881     EISSN: None     Source Type: Journal    
DOI: 10.2147/DDDT.S10945     Document Type: Review

References (44)

1. Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17(7):2105-2116.
2. Smith FO, Downey SG, Klapper JA, et al. Treatment of metastatic melanoma using interleukin-2 alone or in conjunction with vaccines. Clin Cancer Res. 2008;14(17):5610-5618.
3. Dudley ME, Yang JC, Sherry R, et al. Adoptive cell therapy for patients with metastatic melanoma: evaluation of intensive myeloablative chemoradiation preparative regimens. J Clin Oncol. 2008;26(32):5233-5239.
4. Besser MJ, Shapira-Frommer R, Treves AJ, et al. Clinical responses in a phase II study using adoptive transfer of short-term cultured tumor infiltration lymphocytes in metastatic melanoma patients. Clin Cancer Res. 2010;16(9):2646-2655.
5. Rosenberg SA, Yang JC, Sherry RM, et al. Durable complete responses in heavily pretreated patients with metastatic melanoma Using T cell transfer immunotherapy. Clin Cancer Res. 2011;17(13):4550-4557.
6. Sznol M, Powderly JD, Smith DC, et al. Safety and antitumor activity of biweekly MDX-1106 (Anti-PD-1, BMS-936558/ONO-4538) in patients with advanced refractory malignancies [abstract]. J Clin Oncol. 2010;28(15s):2506.
7. Weber J. Immune checkpoint proteins: a new therapeutic paradigm for cancer - preclinical background: CTLA-4 and PD-1 blockade. Semin Oncol. 2010;37(5):430-439.
8. Curran MA, Montalvo W, Yagita H, Allison JP. PD-1 and CTLA-4 combination blockade expands infiltrating T cells and reduces regulatory T and myeloid cells within B16 melanoma tumors. Proc Natl Acad Sci U S A. 2010;107(9):4275-4280.
9. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-723.
10. Lee KM, Chuang E, Griffin M, et al. Molecular basis of T cell inactivation by CTLA-4. Science. 1998;282(5397):2263-2266.
11. Egen JG, Kuhns MS, Allison JP. CTLA-4: new insights into its biological function and use in tumor immunotherapy. Nat Immunol. 2002;3(7):611-618.
12. 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(5):541-547.
13. Waterhouse P, Penninger JM, Timms E, et al. Lymphoproliferative disorders with early lethality in mice deficient in Ctla-4. Science. 1995;270(5238):985-988.
14. Chambers CA, Sullivan TJ, Allison JP. Lymphoproliferation in CTLA- 4-deficient mice is mediated by costimulation-dependent activation of CD4+ T cells. Immunity. 1997;7(6):885-895.
15. Keler T, Halk E, Vitale L, et al. Activity and safety of CTLA-4 blockade combined with vaccines in cynomolgus macaques. J Immunol. 2003;171(11):6251-6259.
16. Morse MA. Technology evaluation: ipilimumab, Medarex/Bristol- Myers Squibb. Curr Opin Mol Ther. 2005;7(6):588-597.
17. Palmisano GL, Tazzari PL, Cozzi E, et al. Expression of CTLA-4 in nonhuman primate lymphocytes and its use as a potential target for specific immunotoxin-mediated apoptosis: results of in vitro studies. Clin Exp Immunol. 2004;135(2):259-266.
18. Anonymous (Study No. DS06064: BMS-663513 and BMS-734016 (MDX-010): One-month Intravenous Combination Toxicity Study in Monkeys. Bristol-Myers Squibb Company, 2007.
19. Kohn DB, Dotti G, Brentjens R, et al. CARs on track in the clinic. Mol Ther. 2011;19(3):432-438.
20. 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.
21. 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.
22. 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 U S A. 2003;100(14):8372-8377.
23. Attia P, Phan GQ, Maker AV, 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(25):6043-6053.
24. Weber JS, O'Day S, Urba W, et al. Phase I/II study of ipilimumab for patients with metastatic melanoma. J Clin Oncol. 2008;26(36): 5950-5956.
25. Maker AV, Yang JC, Sherry RM, et al. Intrapatient dose escalation of anti-CTLA-4 antibody in patients with metastatic melanoma. J Immunother. 2006;29(4):455-463.
26. Wolchok JD, Neyns B, Linette G, et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010;11(2):155-164.
27. Hersh EM, O'Day SJ, Powderly J, et al. A phase II multicenter study of ipilimumab with or without dacarbazine in chemotherapy-naive patients with advanced melanoma. Invest New Drugs. 2011;29(3):489-498.
28. O'Day SJ, Maio M. Chiaron-Sileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol. 2010;21(8): 1712-1717.
29. Weber J, Thompson JA, Hamid O, et al. A randomized, double-blind, placebo-controlled, 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(17):5591-5598.
30. Parkhurst MR, Salgaller ML, Southwood S, et al. Improved induction of melanoma-reactive CTL with peptides from the melanoma antigen gp100 modified at HLA-A*0201-binding residues. J Immunol. 1996;157(6):2539-2548.
31. Kawakami Y, Robbins PF, Wang X, et al. Identification of new melanoma epitopes on melanosomal proteins recognized by tumor infiltrating T lymphocytes restricted by HLA-A1, -A2, and -A3 alleles. J Immunol. 1998;161(12):6985-6992.
32. Wolchok JD, Weber JS, Hamid O, et al. Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun. 2010;10:9.
33. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364(26):2517-2526.
34. Wolchok JD, Hoos A, O'Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009;15(23):7412-7420.
35. 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 Pt 1): 6681-6688.
36. Anonymous YERVOYTM (ipilimumab) Immune-mediated Adverse Reaction Management Guide. FDA-approved REMS. Available at: http://www.yervoy.com/hcp/index.aspx. Accessed November 23, 2011.
37. Flaherty KT, Fisher DE. New strategies in metastatic melanoma: oncogene-defined taxonomy leads to therapeutic advances. Clin Cancer Res. 2011;17(15):4922-4928.
38. Woodman SE, Davies MA. Targeting KIT in melanoma: a paradigm of molecular medicine and targeted therapeutics. Biochem Pharmacol. 2010;80(5):568-574.
39. Flaherty KT, Puzanov I, Kim KB, et al. Inhibition of Mutated, Activated BRAF in Metastatic Melanoma. N Engl J Med. 2010;363(9):809-819.
40. Carvajal RD, Antonescu CR, Wolchok JD, et al. KIT as a therapeutic target in metastatic melanoma. JAMA. 2011;305(22):2327-2334.
41. Woodman SE, Trent JC, Stemke-Hale K, et al. Activity of dasatinib against L576P KIT mutant melanoma: molecular, cellular, and clinical correlates. Mol Cancer Ther. 2009;8(8):2079-2085.
42. Kluger HM, Dudek AZ, McCann C, et al. A phase 2 trial of dasatinib in advanced melanoma. Cancer. 2010;117(10):2202-2208.
43. Satzger I, Kuttler U, Volker B, Schenck F, Kapp A, Gutzmer R. Anal mucosal melanoma with KIT-activating mutation and response to imatinib therapy - case report and review of the literature. Dermatology. 2010;220(1):77-81.
44. Adjei AA, Cohen RB, Franklin W, et al. Phase I pharmacokinetic and pharmacodynamic study of the oral, small-molecule mitogen-activated protein kinase kinase 1/2 inhibitor AZD6244 (ARRY-142886) in Patients With Advanced Cancers. J Clin Oncol. 2008;26(13):2139-2146.