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article imageNew drugs against melanoma show modest, unprecedented progress

By Elizabeth Cunningham Perkins     Jun 6, 2011 in Health
Researchers announced two new drugs and a combination approach against melanoma that significantly prolonged patient survival, tiny gains that show unprecedented progress against this most dangerous skin cancer, one of the deadliest cancers humans face.
Melanoma, a rapidly spreading and highly treatment resistant form of skin cancer that affects melanocytes, the cells that produce skin, hair and eye pigments, is the leading cause of death from skin disease, though it is rarer than other skin cancers, according to PubMed.gov, because the number of cases is on the rise and the disease is so often lethal.
But studies of two new survival-prolonging drugs, ipilimumab (trademarked Yervoy) and vemurafenib, were presented together Sunday at the annual meeting of the American Society of Clinical Oncology, and published online by the New England Journal of Medicine, enthusing experts who have seen little progress at all in the field for several years, according to the AP news agency.
Ipilumumab, previously reported about on Digital Journal, is an immune system enhancer, approved by the U.S. Food and Drug Administration in March.
Vemurafenib, which is not yet approved by the FDA, inhibits a gene mutation present in half of melanoma patients, the V600E mutation in the BRAF gene, according to the researchers.
According to the studies presented Sunday:
In the ipilumumab trial, the first to combine an immune therapy with chemotherapy, 502 patients were randomly assigned to receive ipilumumab in combination with dacarbazine, a chemotherapy drug already widely in use, or dacarbazine and a placebo.
Patients taking only dacarbazine lived a median of 9.1 months, but patients taking the ipilumumab-dacarbazine combination lived a median of 11.2 months.
After a year, 47.3 percent of the group taking the combination were alive, compared to 36.3 percent in chemotherapy-only group. After two years, the rates were 28.5 percent and 17.9 percent, and after three years, 20.8 percent and 12.2 percent.
In the vemurafenib trial, 675 patients were randomly assigned to receive either vemurafenib or dacarbazine.
After six months, 84 percent of the vemurafenib group were still alive, compared to 64 percent of the dacarbazine group, results dramatic enough that an independent data and safety monitoring board recommended patients receiving dacarbazine be allowed to switch to vemurafenib.
Bristol-Myers Squibb, the maker of the immune therapy ipilumumab (Yervoy), and Roche, the maker of the genetic therapy vemurafenib, announced they are already collaborating on a study combining the two new melanoma treatments.
HealthDay News quoted Dr. Stephen Hodi, director of the Melanoma Center at Dana Farber Cancer Institute in Boston, remarking about the unprecedented advance this research has achieved:
"Having two trials that show a benefit in survival in patients with melanoma, both of these in first-line settings -- we weren't here just a few years ago. These are huge, paradigm-shifting results for the field."
More about Melanoma, treatment of melanoma, melanoma treatments, melanoma drugs, melanoma chemoresistance
 
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