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Clinical Trial Report

Ipilimumab: report and comment about the MDX010-020 clinical trial

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Pages 507-512 | Published online: 10 Jan 2014

References

  • Hodi FS, O’Day SJ, McDermott DF et al. Improved survival with ipilimumab in patients with metastatic melanoma. N. Engl. J. Med. 363(8), 711–723 (2010).
  • Tsao H, Atkins MB, Sober AJ. Management of cutaneous melanoma. N. Engl. J. Med. 351(10), 998–1012 (2004).
  • Eggermont AM. Advances in systemic treatment of melanoma. Ann. Oncol. 21(Suppl. 7), vii339–vii344 (2010).
  • Korn EL, Liu PY, Lee SJ et al. Meta-analysis of Phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future Phase II trials. J. Clin. Oncol. 26(4), 527–534 (2008).
  • Agarwala SS. Current systemic therapy for metastatic melanoma. Expert Rev. Anticancer Ther. 9(5), 587–595 (2009).
  • Flaherty KT. Chemotherapy and targeted therapy combinations in advanced melanoma. Clin. Cancer Res. 12(7 Pt 2), 2366s–2370s (2006).
  • Tarhini AA, Kirkwood JM, Gooding WE, Cai C, Agarwala SS. Durable complete responses with high-dose bolus interleukin-2 in patients with metastatic melanoma who have experienced progression after biochemotherapy. J. Clin. Oncol. 25(25), 3802–3807 (2007).
  • Allen IE, Kupelnick B, Kumashiro M, Luo D, Ross SD, Wolin MJ. Efficacy of interleukin-2 in the treatment of metastatic melanoma. Cancer Ther. 1, 168–173 (1998).
  • Lui P, Cashin R, Machado M, Hemels M, Corey-Lisle PK, Einarson TR. Treatments for metastatic melanoma: synthesis of evidence from randomized trials. Cancer Treat. Rev. 33(8), 665–680 (2007).
  • Muranski P, Boni A, Wrzesinski C et al. Increased intensity lymphodepletion and adoptive immunotherapy – how far can we go? Nat. Clin. Pract. Oncol. 3(12), 668–681 (2006).
  • 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. 26(32), 5233–5239 (2008).
  • Rosenberg SA, Yang JC, Restifo NP. Cancer immunotherapy: moving beyond current vaccines. Nat. Med. 10(9), 909–915 (2004).
  • Weber JS, O’Day S, Urba W et al. Phase I/II study of ipilimumab for patients with metastatic melanoma. J. Clin. Oncol. 26(36), 5950–5956 (2008).
  • Pentcheva-Hoang T, Egen JG, Wojnoonski K, Allison JP. B7-1 and B7-2 selectively recruit CTLA-4 and CD28 to the immunological synapse. Immunity 21(3), 401–413 (2004).
  • Fong L, Small EJ. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J. Clin. Oncol. 26(32), 5275–5283 (2008).
  • Wolchok JD, Saenger Y. The mechanism of anti-CTLA-4 activity and the negative regulation of T-cell activation. Oncologist 13(Suppl. 4), 2–9 (2008).
  • Weber J. Overcoming immunologic tolerance to melanoma: targeting CTLA-4 with ipilimumab (MDX-010). Oncologist 13(Suppl. 4), 16–25 (2008).
  • Page DB, Yuan J, Wolchok JD. Targeting cytotoxic T-lymphocyte antigen 4 in immunotherapies for melanoma and other cancers. Immunotherapy 2(3), 367–379 (2010).
  • Quezada SA, Peggs KS, Curran MA, Allison JP. CTLA4 blockade and GM-CSF combination immunotherapy alters the intratumor balance of effector and regulatory T cells. J. Clin. Invest. 116(7), 1935–1945 (2006).
  • 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 110(12), 2614–2627 (2007).
  • Korman A, Yellin M, Keler T. Tumor immunotherapy: preclinical and clinical activity of anti-CTLA4 antibodies. Curr. Opin. Investig. Drugs 6(6), 582–591 (2005).
  • 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 100(8), 4712–4717 (2003).
  • 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 100(14), 8372–8377 (2003).
  • Weber J. Ipilimumab: controversies in its development, utility and autoimmune adverse events. Cancer Immunol. Immunother. 58(5), 823–830 (2009).
  • 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. 23(25), 6043–6053 (2005).
  • 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. 15(17), 5591–5598 (2009).
  • Thompson JA, Hamid O, Minor D et al. Ipilimumab in treatment-naive and previously treated patients with metastatic melanoma: retrospective analysis of efficacy and safety data from a Phase II trial. J. Immunother. 35(1), 73–77 (2012).
  • 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. 28(6), 593–598 (2005).
  • 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. Proc. Am. Soc. Clin. Oncol. 25, Abstract 8523 (2007).
  • Ridolfi L, Ridolfi R. Anti-CTLA-4 therapy in melanoma: role of ipilimumab (MDX-010). Expert Rev. Dermatol. 4, 199–210 (2009).
  • 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. 15(23), 7412–7420 (2009).
  • O’Day SJ, Maio M, Chiarion-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. 21(8), 1712–1717 (2010).
  • Hanaizi Z, van Zwieten-Boot B, Calvo G et al. The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use. Eur. J. Cancer 48(2), 237–242 (2012).
  • Weber J. Immunotherapy for melanoma. Curr. Opin. Oncol. 23(2), 163–169 (2011).
  • Robert C, Thomas L, Bondarenko I et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N. Engl. J. Med. 364(26), 2517–2526 (2011).
  • Yuan J, Adamow M, Ginsberg BA et al. Integrated NY-ESO-1 antibody and CD8+ T-cell responses correlate with clinical benefit in advanced melanoma patients treated with ipilimumab. Proc. Natl Acad. Sci. USA 108(40), 16723–16728 (2011).
  • Yang JC. Melanoma vaccines. Cancer J. 17(5), 277–282 (2011).
  • Turcotte S, Rosenberg SA. Immunotherapy for metastatic solid cancers. Adv. Surg. 45, 341–360 (2011).
  • Prieto PA, Yang JC, Sherry RM et al. CTLA-4 blockade with ipilimumab: long-term follow-up of 177 patients with metastatic melanoma. Clin. Cancer Res. 18(7), 2039–2047 (2012).
  • Chapman PB, Hauschild A, Robert C et al.; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 364(26), 2507–2516 (2011).
  • Ribas A, Hodi FS, Kurland JF et al. CA184-161: a Phase I/II trial of vemurafenib and ipilimumab in patients with BRAF V600 mutation-positive metastatic melanoma. J. Clin. Oncol. 30, Abstract TPS8603 (2012).
  • 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. 13(22 Pt 1), 6681–6688 (2007).
  • Bouwhuis MG, Ten Hagen TL, Suciu S, Eggermont AM. Autoimmunity and treatment outcome in melanoma. Curr. Opin. Oncol. 23(2), 170–176 (2011).
  • Weber JS, Hamid O, Chasalow SD et al. Ipilimumab increases activated T cells and enhances humoral immunity in patients with advanced melanoma. J. Immunother. 35(1), 89–97 (2012).
  • Hamid O, Schmidt H, Nissan A et al. A prospective Phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J. Transl. Med. 9, 204 (2011).
  • von Euw E, Chodon T, Attar N et al. CTLA4 blockade increases Th17 cells in patients with metastatic melanoma. J. Transl. Med. 7, 35 (2009).
  • Roesch A, Fukunaga-Kalabis M, Schmidt EC et al. A temporarily distinct subpopulation of slow-cycling melanoma cells is required for continuous tumor growth. Cell 141(4), 583–594 (2010).
  • Fukunaga-Kalabis M, Roesch A, Herlyn M. From cancer stem cells to tumor maintenance in melanoma. J. Invest. Dermatol. 131(8), 1600–1604 (2011).

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