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Trial Therapy Improves Melanoma Survival
Date:8/19/2010

By Amanda Gardner
HealthDay Reporter

WEDNESDAY, Aug. 18 (HealthDay News) -- An experimental drug for metastatic melanoma prolonged median survival from 6.4 months to 10 months, which, although seemingly small, represents a significant extension of life for this normally intractable disease, a new study found.

And a subgroup of patients given the drug, known as ipilimumab, lived as long as six years, according to research published in the Aug. 19 issue of the New England Journal of Medicine.

This type of skin cancer has an average survival time of six to nine months.

"This is the first drug that's ever been shown in a randomized, controlled trial to offer a survival benefit for patients," said study lead author Dr. F. Stephen Hodi, director of the melanoma disease center at Dana Farber Cancer Institute in Boston.

The findings were first reported in June at the annual meeting of the American Society of Clinical Oncology in Chicago. The study was funded by Bristol-Myers Squibb and its biotechnology subsidiary Medarex, which makes ipilimumab.

Only two drugs have been approved by the U.S. Food and Drug Administration to treat melanoma that has spread beyond its original site: interleukin 2, or IL-2, and dacarbazine. IL-2 is a drug that affects the immune system while dacarbazine is a chemotherapy agent.

There have been no new FDA approvals of drugs for metastatic melanoma in more than a decade.

Ipilimumab is a human monoclonal antibody, which targets an antigen known as CTLA-4 that is found on the surface of T cells, which are blood cells that protect the body from infection.

CTLA-4 inhibits the immune system and "ipilimumab releases the brakes to the immune system," Hodi explained. That way, T cells are free to move throughout the body and attack the melanoma cells.

For this study, 676 patients with advanced melanoma were randomly chosen to receive either ipilimumab
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