PMID- 21900389 OWN - NLM STAT- MEDLINE DCOM- 20120325 LR - 20240513 IS - 1557-3265 (Electronic) IS - 1078-0432 (Print) IS - 1078-0432 (Linking) VI - 17 IP - 22 DP - 2011 Nov 15 TI - Ipilimumab: an anti-CTLA-4 antibody for metastatic melanoma. PG - 6958-62 LID - 10.1158/1078-0432.CCR-11-1595 [doi] AB - Ipilimumab (MDX-010, Yervoy; Bristol-Myers Squibb), a fully human monoclonal antibody against CTL antigen 4 (CTLA-4), was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma. In both early- and late-phase trials, ipilimumab has shown consistent activity against melanoma. For example, in a randomized phase III trial that enrolled patients with previously treated metastatic disease, ipilimumab, with or without a peptide vaccine, improved overall survival: Median overall survival was 10.1 and 10.0 months in the ipilimumab and ipilimumab plus vaccine arms, respectively, versus 6.4 months in the vaccine-alone group (hazard ratio, 0.68; P </= 0.003). Serious (grade 3-5) immune-related adverse events occurred in 10% to 15% of patients. Thus, although it provides a clear survival benefit, ipilimumab administration requires careful patient monitoring and sometimes necessitates treatment with immune-suppressive therapy. Here, we review the mechanism of action, preclinical data, and multiple clinical trials that led to FDA approval of ipilimumab for metastatic melanoma. FAU - Lipson, Evan J AU - Lipson EJ AD - Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland 21231, USA. FAU - Drake, Charles G AU - Drake CG LA - eng GR - P50 CA058236/CA/NCI NIH HHS/United States GR - R01 CA127153/CA/NCI NIH HHS/United States GR - 1P50CA58236-15/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20110907 PL - United States TA - Clin Cancer Res JT - Clinical cancer research : an official journal of the American Association for Cancer Research JID - 9502500 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antineoplastic Agents) RN - 0 (CTLA-4 Antigen) RN - 0 (Ipilimumab) SB - IM MH - Antibodies, Monoclonal/adverse effects/*pharmacology/*therapeutic use MH - Antineoplastic Agents/adverse effects/pharmacology/*therapeutic use MH - CTLA-4 Antigen/drug effects/immunology MH - Clinical Trials as Topic MH - Humans MH - Ipilimumab MH - Melanoma/*drug therapy/secondary MH - Skin Neoplasms/*drug therapy/pathology PMC - PMC3575079 MID - NIHMS438132 EDAT- 2011/09/09 06:00 MHDA- 2012/03/27 06:00 PMCR- 2013/02/18 CRDT- 2011/09/09 06:00 PHST- 2011/09/09 06:00 [entrez] PHST- 2011/09/09 06:00 [pubmed] PHST- 2012/03/27 06:00 [medline] PHST- 2013/02/18 00:00 [pmc-release] AID - 1078-0432.CCR-11-1595 [pii] AID - 10.1158/1078-0432.CCR-11-1595 [doi] PST - ppublish SO - Clin Cancer Res. 2011 Nov 15;17(22):6958-62. doi: 10.1158/1078-0432.CCR-11-1595. Epub 2011 Sep 7.