E-MAIL PRINT

Melanoma drug nearly doubles survival rates

Investigators from Vanderbilt-Ingram Cancer Center and 12 other centers in the United States and Australia have found that a new drug for patients with metastatic melanoma nearly doubled median overall survival.

More than half of patients who were treated with the novel drug vemurafenib, known commercially as Zelboraf, responded to treatment and experienced an impressive median overall survival of nearly 16 months — far longer than the typical survival of just six to 10 months for patients whose melanoma has spread beyond the initial tumor site.
Results from the Phase II trial were published in the New England Journal of Medicine.

“This study confirms what we have discovered in our earlier trials. Many of our patients are exhibiting a strong, immediate response to this drug and some are living significantly longer, with manageable side effects,” said Jeffrey Sosman, M.D., director of the Melanoma and Tumor Immunotherapy Program.

Approximately half of all patients with metastatic melanoma – the most deadly form of skin cancer – have a BRAF V600 mutation in their tumor. Vemurafenib is an FDA-approved oral drug which works as a kinase inhibitor of the BRAF V600 mutation.

While vemurafenib induced clinical responses in a significant number of BRAF-positive patients when it was approved last year, the initial clinical trials had not followed patients long enough to determine overall survival.

A total of 132 patients with stage IV, BRAF-positive melanoma were enrolled in the Phase II trial. All of the patients had received at least one form of systemic treatment before enrollment in the trial.

Forty-seven percent of patients had a partial response to the drug and 6 percent exhibited a complete response, for an overall response rate of 53 percent.

The study is the first to confirm the durability of the response.