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01.05.2011 | R&D Insight Profile

Ipilimumab

First Global Approval

Erschienen in: Drugs | Ausgabe 8/2011

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Abstract

Ipilimumab (Yervoy®) is an anti-cytotoxic T-lymphocyte antigen (CTLA)-4 monoclonal antibody that has been approved in the US for the first- or second-line treatment of patients with malignant melanoma. In the EU, it is awaiting approval as second-line therapy for melanoma. Ipilimumab blocks the effects of the negative T-cell regulator CTLA-4, which may in turn augment T-cell responses to tumour cells. Preclinical studies have indicated that antibody blocking of CTLA-4 can lead to potent immune responses. Ipilimumab is also in development as first- and second-line therapy for prostate cancer where it has progressed to phase III clinical trials worldwide, and it is in phase II development for non-small cell lung cancer. Ipilimumab was originated by the University of California, Berkeley, in the US and subsequently licensed to Medarex, which was later acquired by Bristol-Myers Squibb. This article summarizes the milestones in the development of intravenous ipilimumab leading to this first approval.

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10.

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11.

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12.

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13.

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14.

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15.

Bristol-Myers Squibb Company. Investigational Compound Ipilimumab Demonstrates Improved Overall Survival in Phase 3 Trial of Previously-Treated Patients with Metastatic Melanoma. Media Release: 6 Jun 2010. Available from URL: http://www.bms.com

16.

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17.

Bristol-Myers Squibb Company, Medarex Inc. Results from Three Phase 2 Studies Reported a Two-Year Survival Rate Ranging from 30 to 42 Percent in Metastatic Melanoma Patients Treated with Ipilimumab (10 mg/kg). Media Release: 1 Jun 2009. Available from URL: http://www.bms.com

18.

Bristol-Myers Squibb Company, Medarex Inc. Updated Survival Data from Three Phase 2 Ipilimumab Studies Showed Almost Half of Previously Treated Metastatic Melanoma Patients Alive Beyond One Year. Media Release: 16 Sep 2008. Available from URL: http://www.bms.com

19.

Bristol-Myers Squibb Company, Medarex Inc. New Ipilimumab Survival Data in Patients with Metastatic Melanoma Presented at American Society of Clinical Oncology Annual Meeting. Media Release: 2 Jun 2008. Available from URL: http://www.medarex.com

20.

Medarex Inc, Bristol-Myers Squibb. Top-Line Data Available from Three Ipilimumab Pivotal Trials in Patients with Advanced Metastatic Melanoma. Media Release: 10 Dec 2007. Available from URL: http://www.medarex.com

21.

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22.

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23.

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24.

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25.

Medarex Inc. Ipilimumab Plus Chemotherapy is Associated with Prolonged Survival and Increased Disease Control Rates in Patients with Advanced Melanoma. Media Release: 1 Jun 2008. Available from URL: http://www.medarex.com

26.

Medarex Inc. Data Demonstrated Metastatic Melanoma Response to Investigational Immunotherapy Ipilimumab. Media Release: 5 Jun 2007. Available from URL: http://www.bms.com

27.

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28.

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29.

Medarex Inc, Bristol-Myers Squibb Company. Phase II Clinical Study of MDX-010/MDX-1379 Combination Shows Durable Responses in Patients with Metastatic Melanoma. Media Release: 20 Apr 2005. Available from URL: http://www.medarex.com. Bristol-Myers Squibb Company, New York, New York, USA

30.

Medarex Inc. Interim Ipilimumab (MDX-010) Phase II Trial Results Indicate Well-Tolerated, Extended Dosing with Preliminary Evidence that Immune Activation May Reduce Relapse in the Adjuvant Setting in Melanoma. Media Release: 5 Jun 2006. Available from URL: http://www.medarex.com

31.

Medarex Inc, Bristol-Myers Squibb. Medarex and Bristol-Myers Squibb Announce Complete and Partial Responses Observed in Phase I/II Clinical Study of MDX-010 in Combination with Il-2. Media Release: 7 Mar 2005. Available from URL: http://www.medarex.com. Medarex Inc, Princeton, New Jersey, USA

32.

Urba WJ, Weber JS, O’Day SJ, et al. Long-term survival of patients with advanced melanoma who received ipilimumab administered at 10 mg/kg every 3 weeks for 4 doses (induction dosing). 44th Annual Meeting of the American Society of Clinical Oncology: abstr. 3018, 30 May 2008. Available from URL: http://www.asco.org. Medarex, Inc., Princeton, New Jersey, USA

33.

Medarex Inc. Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting. Media Release: 15 Apr 2008. Available from URL: http://www.medarex.com

34.

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35.

Beer TM, Slovin SF, Higano CS, et al. Prostate Cancer Clinical Trials Consortium. Phase I trial of ipilimumab alone and in combination with radiotherapy in patients with metastatic castration resistant prostate cancer. 44th Annual Meeting of the American Society of Clinical Oncology: abstr. 5004, 30 May 2008. Available from URL: http://www.asco.org. Medarex, Princeton, New Jersey, USA

36.

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37.

Medarex Inc. Ipilimumab (MDX-010) Safety and Clinical Response Data in Lymphomas and Leukemia Presented at the 48th American Society of Hematology Annual Meeting. Media Release: 11 Dec 2006. Available from URL: http://www.medarex.com

38.

Yang JC, Beck KE, Blansfield JA, et al.. Tumor regression in patients with metastatic renal cancer treated with a monoclonal antibody to CTLA4 (MDX-010). Journal of Clinical Oncology 23 (Suppl.): 166 (plus oral presentation) abstr. 2501, No. 16, Part I, 1 Jun 2005. Medarex Inc, Bloomsbury, New Jersey, USA

39.

Hodi FS, Seiden M, Butler M, et al. Cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody blockade in patients previously vaccinated with irradiated, autologous tumor cells engineered to secrete granulocyte-macrophage colony stimulating factor (GM-CSF). 40th Annual Meeting of the American Society of Clinical Oncology: 172, Jun 2004. Medarex, Bloomsbury, NJ, USA

40.

Weber JS, Berman D, Siegel J, et al. Clinical activity of ipilimumab in patients with advanced melanoma and brain metastases. 33rd Congress of the European Society for Medical Oncology: abstr. 786P, 12 Sep 2008. Available from URL: http://annonc.oxfordjournals.org. Bristol-Myers-Squibb, Wallingford, Connecticut, USA

41.

Lebbe C, Hoos A, Chin K, et al. Effect of dose on efficacy and safety in ipilimumab-treated patients with advanced melanoma — results from a phase II, randomized, dose-ranging study. 33rd Congress of the European Society for Medical Oncology: abstr. 769O, 12 Sep 2008. Available from URL: http://annonc.oxfordjournals.org. Saint-Louis Hospital, Paris, France

42.

Cell Genesys Inc, Medarex Inc. Cell Genesys and Medarex Announce Encouraging Interim Results from a Phase 1 Combination Therapy Trial With GVAX(R) Immuno-therapy for Prostate Cancer and Ipilimumab (MDX-010) Antibody. Media Release: 3 Jun 2006. Available from URL: http://www.cellgenesys.com

43.

Bristol-Myers Squibb Company. Phase III Study of Investigational Compound Ipilimumab Achieves Primary Endpoint of Improvement in Overall Survival in Previously-Untreated Patients with Metastatic Melanoma. Media Release: 22 Mar 2011. Available from URL: http://www.bms.com

44.

Medarex Inc. Medarex Highlights Oncology Pipeline at Needham Cancer Therapeutics Conference in New York City. Media Release: 26 Mar 2009. Available from URL: http://www.medarex.com

45.

Medarex Inc. Medarex Announces Ipilimumab Program Continues to Move Forward. Media Release: 3 Apr 2008. Available from URL: http://www.medarex.com

46.

Medarex Inc. Medarex Announces Special Protocol Assessment Agreement With the FDA to Initiate Registrational Trial for Ipilimumab (MDX-010) Combination With Chemotherapy in First-Line Metastatic Melanoma Patients. Media Release: 19 Jun 2006. Available from URL: http://www.medarex.com

47.

Medarex Inc. Medarex Announces FDA Fast Track Designations for Ipilimumab for the Treatment of Metastatic Melanoma; Fast Track Designations for First-Line Use in Combination With Chemotherapy and Second-Line Use as Monotherapy. Media Release: 7 Dec 2006. Available from URL: http://www.medarex.com

Titel: Ipilimumab
First Global Approval
Publikationsdatum: 01.05.2011
Erschienen in: Drugs / Ausgabe 8/2011
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.2165/11594010-000000000-00000

Springer Medizin

Abstract

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