Ipilimumab: In previously treated patients with advanced melanoma

BioDrugs

Volumn 26, Issue 3, 2012, Pages 185-193

  Sanford, Mark ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Profiles; Ipilimumab; Malignant melanoma

Indexed keywords

GLYCOPROTEIN GP 100; GLYCOPROTEIN GP 100 PEPTIDE VACCINE; IPILIMUMAB; PEPTIDE VACCINE; PLACEBO; UNCLASSIFIED DRUG;

ARTICLE; CANCER CHEMOTHERAPY; CANCER PATIENT; CONSTIPATION; DECREASED APPETITE; DIARRHEA; DRUG CLEARANCE; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG FEVER; DRUG HALF LIFE; DRUG MECHANISM; DRUG TOLERABILITY; FATIGUE; HUMAN; MELANOMA; NAUSEA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SYSTEMATIC REVIEW; VOMITING;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; HUMANS; IMMUNITY, HUMORAL; LYMPHOCYTE ACTIVATION; MELANOMA; RANDOMIZED CONTROLLED TRIALS AS TOPIC; T-LYMPHOCYTES, CYTOTOXIC; TREATMENT OUTCOME;

EID: 84860646542     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.2165/11208200-000000000-00000     Document Type: Article

References (33)

1. WHO International Agency for Research on Cancer. GLOBOCAN 2008: cancer incidence and mortality worldwide in 2008 [online]. Available from http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=900 [Accessed 2010 Jul 2]
2. Marsden JR, Newton-Bishop JA, Burrows L, et al. Revised UK guidelines for the management of cutaneous melanoma 2010. Br J Dermatol 2010 Aug; 163 (2): 238-56
3. Bhatia S, Tykodi SS, Thompson JA. Treatment of metastatic melanoma: an overview. Oncology (Williston) 2009 May; 23 (6): 488-96
4. Barth A, Wanek LA, Morton DL. Prognostic factors in 1,521 melanoma patients with distant metastases. J Am Coll Surg 1995; 181: 193-201
5. 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 Jul; 17 (7): 2105-16
6. Blesa JMG, Pulido EG, Candel VA, et al. Melanoma: from darkness to promise. Am J Clin Oncol 2011 Apr; 34 (2): 179-87
7. Schwartzentruber DJ, Lawson DH, Richards JM, et al. gp100 peptide vaccine and interleukin-2 in patients with advanced melanoma. N Engl J Med 2011 Jun 2; 364 (22): 2119-27
8. Ribas A, Hauschild A, Kefford R, et al. Phase III, open-label, randomized, comparative study of tremelimumab (CP-675,206) and chemotherapy (te- mozolomide [TMZ] or dacarbazine [DTIC]) in patients with advanced melanoma [abstract no. LAB9011]. J Clin Oncol 2008 May 20; 26 Suppl.: 15S
9. Bristol-Myers SquibbCo. Yervoy- (ipilimumab) injection for infusion: prescribing information [online].Available fromURL: http://www.accessdata.fda. gov/ drugsatfda-docs/label/2011/125377s0000lbl.pdf [Accessed 2011 Aug 3]
10. European Medicines Agency. Yervoy 5mg/ml concentrate for solution for infusion: EUsummary of product characteristics [online].Available fromURL: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/002213/WC500109299.pdf [Accessed 2010 Aug 15]
11. Weber JS, Hamid O, Chasalow SD, et al. Ipilimumab increases activated T cells and enhances humoral immunity in patients with advanced melanoma. J Immunother 2012 Jan; 35 (1): 89-97
12. Hodi FS, ButlerM, ObleDA, et al. Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyte-associated antigen 4 in previously vaccinated cancer patients. Proc Natl Acad Sci USA 2008 Feb 26; 105 (8): 3005-10
13. Berman D, Parker SM, Siegel J, et al. Blockade of cytotoxic T-lymphocyte antigen-4 by ipilimumab results in dysregulation of gastrointestinal immunity in patients with advanced melanoma. Cancer Immun 2010; 10: E11
14. 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): 6043-53
15. Weber JS, Yu B, Hall M, et al. Pharmacodynamic and predictive markers of ipilimumab on melanoma patient's T-cells [abstract no. 2503]. J Clin Oncol 2011 May; 29 (15 Suppl.)
16. 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 Nov 15; 13 (22): 6681-8
17. Breunis WB, Tarazona-Santos E, Chen R, et al. Influence of cytotoxic T lymphocyte-associated antigen 4 (CTLA4) common polymorphisms on outcome in treatment of melanoma patients with CTLA-4 blockade. J Immunother 2008 Jul-Aug; 31 (6): 586-90
18. 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: E9
19. Jackson J, Whitney G, Hamid O, et al. Assessment of association between BRAF mutation status in melanoma tumors and response to ipilimumab [abstract no. 2587]. J Clin Oncol 2011 May 20; 29 (15 Suppl.)
20. Agarwala SS. Novel immunotherapies as potential therapeutic partners for traditional or targeted agents: cytotoxic T-lymphocyte antigen-4 blockade in advanced melanoma. Melanoma Res 2010 Feb; 20 (1): 1-10
21. Weber J, Thompson JA, Hamid O, 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 Sep 1; 15 (17): 5591-8
22. Dai G, Masson E, Wu C, et al. Modeling and simulation based evidence of clinical activity for ipilimumab, a novel anti-CTLA-4 monoclonal antibody, in patients with advanced melanoma [abstract no. PII-71]. Clin Pharmacol Ther 2009 Feb; 85 Suppl. 1: S58
23. Dai D, Wu C, Parker SM, et al. Model-based evaluation of ipilimumab dosage regimen in patients with advanced melanoma [abstract no. 9037]. 44th Annual Meeting of the American Society of Clinical Oncology 2008 May 30-Jun 3; Chicago (IL)
24. Weber JS, Hamid O, Wolchok J, et al. Assessment of pharmacokinetic interaction between ipilimumab and chemotherapy in a randomized study [abstract no. 1329P]. Ann Oncol 2010 Oct; 21 Suppl. 8: viii403
25. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma [published erratum appears in N Engl J Med 2010 Sep 23; 363 (13): 1290].NEngl J Med 2010 Aug 19; 363 (8): 711-23
26. Robert C, Hodi FS, O'Day SJ, et al. Re-induction with ipilimumab, GP100 peptide vaccine, or a combination of both in a phase III study of previouslytreated patients with advanced melanoma: update of clinical characteristics of patients [abstract no. 1330P]. Ann Oncol 2010 Oct; 21 Suppl. 8: viii403
27. Lorigan P, Sosman JA, Haanen JB, et al. Clinical response to ipilimumab: effect of systemic corticosteroids used to manage immune-related adverse events (irAEs) [abstract no. 1331P]. Ann Oncol 2010 Oct; 21 Suppl. 8: viii404
28. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011 Jun 30; 364 (26): 2517-26
29. O'Day S, Weber JS, Wolchok JD, et al. Effectiveness of treatment guidance on diarrhea and colitis across ipilimumab studies [abstract no. 8554]. J Clin Oncol 2011 May 20; 29 (15 Suppl.)
30. Ibrahim RA, Berman DM, DePril V, et al. Ipilimumab safety profile: summary of findings from completed trials in advanced melanoma [abstract no. 8583]. J Clin Oncol 2011 May 20; 29 (15 Suppl.)
31. Kaehler KC, Piel S, Livingstone E, et al. Update on immunologic therapy with anti-CTLA-4 antibodies in melanoma: identification of clinical and biological response patterns, immune-related adverse events, and their management. Semin Oncol 2010 Oct; 37 (5): 485-98
32. Eastern Cooperative Oncology Group. Ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery [ClinicalTrials.gov identifier NCT01274338]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Aug 16]
33. Bristol-Meyers Squibb. Efficacy study of ipilimumab versus placebo to prevent recurrence after complete resection of high risk stage III melanoma [ClinicalTrials.gov identifier NCT00636168]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials. gov [Accessed 2011 Aug 16]