According to results presented at the 59th annual Cancer Symposium of the Society of Surgical Oncology, the vaccine MDX-010 in addition to interleukin-2 provides anti-cancer responses in patients with metastatic melanoma. MDX-010 is now in the last phase of clinical trials prior to FDA review.

Malignant melanoma is a type of skin cancer that often begins in the form of a mole. Malignant melanoma is considered a very aggressive cancer and tends to quickly spread in the body. It is the most deadly type of skin cancer. In the United States, the incidence of melanoma has demonstrated an approximate 4% increase annually, with nearly 54,000 patients diagnosed with this disease in 2002. For women in the U.S. between the ages of 25 to 30, melanoma is the number one cause of cancer deaths. Metastatic melanoma refers to melanoma that has spread from its site of origin to distant sites in the body, often invading vital organs. Melanoma is notorious for being relatively unresponsive to standard therapeutic approaches such as chemotherapy and/or radiation therapy, and treatment for metastatic melanoma is most often delivered to improve the quality of life or duration of survival of a patient, not with intent to cure. Standard treatment consists of the surgical removal of the cancer if possible, the chemotherapy agent dacarbazine and/or biologic therapy with interleukin-2 or interferon.

Biologic therapy, or therapy involving the immune system, is a type of treatment approach that is being evaluated extensively in melanoma. Some patients with melanoma who are not responsive to standard therapeutic approaches have demonstrated impressive anti-cancer responses to immune therapy that has stimulated their immune system to fight cancer cells. MDX-010 is a type of vaccine that is comprised of a protein that is targeted against CTLA-4. CTLA-4 is a molecule that is found on a specific type of immune cells and is believed to suppress the immune system. MDX-010 disables the ability of CTLA-4 to suppress the immune system, and is thought to potentially stimulate the immune system to help attack cancer cells in the body.

A recent clinical trial was conducted to evaluate MDX-010 in addition to high-dose interleukin-2 in patients with metastatic melanoma. This trial included 36 patients who were treated at 3 different dose levels of MDX-010. Overall, 8 patients achieved an anti-cancer response, with 3 achieving a complete disappearance of detectable cancer (complete response). Two of the patients achieving a complete response have not developed cancer progression at over 13 months following treatment with MDX-010, and the third patient achieving a complete response has not developed cancer progression at over 16 months following treatment with MDX-010. The remaining 5 patients achieving an anti-cancer response had responses ranging from 7 months to over 19 months. Five patients reported severe side effects, including inflammation of the colon, uvea and pancreas, as well as throat (larynx) spasms and arthritis. However, these side effects were reversible upon cessation of therapy.

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The researchers concluded that the addition of MDX-010 to interleukin-2 may provide additional anti-cancer activity in patients with metastatic melanoma. Patients who achieved anti-cancer responses to therapy tended to have sustained responses, particularly those who achieved a complete response. Results from the last phase of clinical trials are necessary to help prove the true clinical effectiveness of MDX-010 in this patient population. Patients with metastatic melanoma may wish to speak with their physician regarding the risks and benefits of participating in a clinical trial further evaluating MDX-010 or other novel therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (cancer.gov) and www.cancerconsultants.com.

Reference: Medarex. Medarex and Bristol-Myers Squibb Announce Complete and Partial Responses Observed in Phase I/II Clinical Study of MDX-010 in Combination with Il-2. Available at: http://www.medarex.com/cgi-local/item.pl/20050307-682075. Accessed March 2005.

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