Metastatic Melanoma Patients Receive Two More Treatment Options in Vemurafenib and Ipilimumab

by Dr Sam Girgis on June 6, 2011

Melanoma, the most aggressive form of skin cancer, kills about 9,000 Americans every year.  The five year survival of patients with melanoma is just 15%.  In the United States, more than 70,000 people are diagnosed with the disease each year, and there are over 800,000 people living with the disease according to the American Cancer Society.  The traditional treatment of melanoma is with the chemotherapeutic drug dacarbazine, which usually results in a median survival of 6-8 months.  Two recent advances in the treatment of melanoma were announced in Chicago on June 5, 2011 at the annual meeting of the American Society of Clinical Oncology.  The results were also published simultaneously online in the New England Journal of Medicine.  Researchers have shown that two new drugs can significantly improve survival of patients with metastatic melanoma.  In the first study, lead by Dr. Paul Chapman of Memorial Sloan Kettering Cancer Center in New York City, investigators conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma.  About 50% of melanomas have a mutation in the BRAF protein kinase, which is known as BRAF V600E.  Vemurafenib targets this mutation and inhibits its cancer causing potential.  The study participants were randomly assigned to receive either vemurafenib or dacarbazine.  At the six month time point, overall survival was 84% in the vemurafenib group compared to only 64% in the dacarbazine group.  In addition, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine.  The results were so remarkable that an independent data and safety monitoring board recommended stopping the study early and providing vemurafenib to the study participants taking dacarbazine.  In the second study, lead by Dr. Jedd Wolchok of Memorial Sloan Kettering Cancer Center in New York City, investigators conducted a phase 3 randomized clinical trial of ipilimumab plus dacarbazine in patients with previously untreated metastatic melanoma.  Ipilimumab (Yervoy) is a human antibody that binds to and blocks the activity of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), and thus causes a sustained and active immune response against cancer cells.  The investigators randomly assigned 502 patients with previously untreated metastatic melanoma to receive ipilimumab plus dacarbazine or dacarbazine plus placebo.  The group receiving ipilimumab plus dacarbazine had significantly greater overall survival compared to the group receiving dacarbazine plus placebo (11.2 months vs. 9.1 months).  These are very remarkable and exciting advances for the field of melanoma cancer treatment, which has not seen improvements in more than 30 years.  Ipilimumab has already received approval from the Food and Drug Administration, and approval for vemurafenib is expected later this year.  The pharmaceutical companies who manufacture vemurafenib and ipilimumab, Roche and Bristol-Myers Squibb respectively, have announced that they will be working on a collaborative study to evaluate the benefits of using both drugs together as a treatment for metastatic melanoma.  These are truly exciting times for both melanoma patients and cancer researchers.

See the YouTube video entitled “Advances in the Treatment of Melanoma” released by mskcc.org below:

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