Phase 3 study of ipilimumab for previously treated metastatic melanoma

Bristol-Myers Squibb announced positive results from a Phase 3 study of ipilimumab which demonstrated that overall survival (OS) was significantly extended in patients with previously-treated metastatic melanoma who received ipilimumab. This study (Study 020) is a randomized, double-blind global Phase 3 study of patients with unresectable Stage III or IV metastatic melanoma who have received prior therapies and were HLA-A2+. HLA-A2+ is a group of proteins that play a role in the body's immune system and the gp100 vaccine used as the comparator in study 020 is specific for patients who are HLA-A2+. The study met its primary endpoint of overall survival for patients treated with ipilimumab (hazard ratio = 0.66 – 0.6). Forty four to 46 percent of patients treated with ipilimumab were alive at one year and 22 to 24 percent were alive at 2 years.  Median overall survival for study patients was extended by 3.6 to 3.7 months.  

Ipilimumab is a novel T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. Suppression of CTLA-4 can augment the immune system's T-cell response in fighting disease.

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