The results of the late stage phase 3 clinical trial involving 799 men was published in the journal European Urology by researchers at the Medical University of Vienna.
The antibody ipilimumab (YERVOY®) targets and immune system molecule that cancer uses to deactivate immune system cells that act against the cancer. The antibody blocks the deactivation of those cells. It has been used previously in improving survival in patients with melanoma, lung cancer and bladder cancer.
The trial was conducted at cancer centers in the US, Canada, South America, Australia and European countries. Patients were randomly assigned to receive the antibody or a look-a-like placebo. After analyses done 3, 4 and 5 years after treatment found that survival at each time point was two to three times higher in the antibody group compared to the placebo group.
Specifically, 2 years after treatment overall survival rates were 25.2% in the ipilimumab compared to 16.6% in the placebo group. At 3 yrs 15.3% of the antibody group survived compared to 7.9% of the placebo group. Similarly at 4 years 10.1% of the antibody group survived compared to 3.3%, and at 5 years 7.9% of the antibody group survived compared to 2.7% of the placebo group.
The serious side effects of YERVOY include intestinal problems (colitis), liver problems (hepatitis), and skin, nerve and glandular effects.
The serious side effects of YERVOY include intestinal problems (colitis), liver problems (hepatitis), and skin, nerve and glandular effects.
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