期刊
CLINICAL CANCER RESEARCH
卷 17, 期 22, 页码 6958-6962出版社
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1078-0432.CCR-11-1595
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资金
- NIH [R01 CA127153, 1P50CA58236-15]
- Patrick C. Walsh Fund
- OneInSix Foundation
- Prostate Cancer Foundation
- John P. Hussman Foundation
- NIH/NCI
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. Clin Cancer Res; 17(22); 6958-62. (C) 2011 AACR.
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