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Antibody therapy lengthens survival of metastatic melanoma patients in large clinical trial
Date:6/7/2010

st other cancers. Associated with extended periods of exposure to ultraviolet rays in sunlight, the disease is expected to be diagnosed in more than 68,000 Americans and be responsible for 8,700 deaths in this country in 2010, according to the American Cancer Society. There are no approved therapies for metastatic melanoma beyond standard frontline treatments, and no previous therapy for the disease has been proven effective in a phase III clinical trial.

Ipilimumab, developed by Bristol-Myers Squibb and Medarex, consists of millions of copies of a human antibody that binds to a molecule on T cells white blood cells that patrol the body for signs of illness. The molecule, known as CTLA-4, serves as a control switch for the immune system's response to disease. With no antibody attached, CTLA-4 suppresses the immune response. Ipilimumab reverses that condition, unleashing the immune attack on abnormal cells, including cancer cells. "It essentially takes a brake off the immune system," Hodi says.

The new phase III trial involved 676 patients with advanced (stage III or IV), inoperable melanoma that had worsened during prior therapy for metastatic disease. Patients were randomly assigned to receive one of three treatment regimens: ipilimumab and the gp100 vaccine (which seeks to spark an immune response by presenting the immune system with a protein fragment associated with cancer), ipilimumab alone, or gp 100 alone.

The median survival period for patients receiving ipilimumab plus gp100 was 10 months, compared with 6.4 months for those receiving gp100 alone. The median survival for participants receiving ipilimumab alone was 10.1 months. In the ipilimumab-alone group, nine of 15 patients continued to benefit from the therapy for at least two years, as did four of 23 patients in the combination therapy group.

About 60 percent of the patients treated with ipilimumab experienced adverse side effects to the therapy, as did 32 pe
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Contact: Bill Schaller
william_schaller@dfci.harvard.edu
617-233-5507
Dana-Farber Cancer Institute
Source:Eurekalert

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