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Melanoma Drug Trials Show Significant Promise

By targeting immune system, new treatments extend average survival

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The results are even more impressive considering that many of the patients already had undergone as many as three rounds of drug therapy for their melanoma, said Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society.

"Many of those patients were pretreated before they got this drug, which means earlier treatment had failed," Lichtenfeld said. "When you see results like that, you certainly stand up and take notice."

Phase 3, or final, trials have been completed regarding the combination therapy, Sznol said, and it's hoped the results will be out in a year.

The second clinical trial, which involved 951 patients, also reported strong results from Yervoy. It found that the drug reduced cancer's return by roughly 25 percent when compared to placebo, or dummy, medication in patients who had surgery for high-risk stage 3 melanoma.

The drug was given every three weeks for four doses, and treatment continued at three-month intervals up to three years. Three-year, recurrence-free survival rates were 46.5 percent in the Yervoy group, compared with 34.8 percent in the placebo group.

Both studies reported severe side effects, however. Five treatment-related deaths occurred in the second clinical trial, and about half the patients discontinued treatment because of side effects such as skin rash and inflammation of the colon, thyroid and pituitary gland.

Side effects appeared even more pronounced in the combination therapy trial. "When we give the two drugs together, we see a greater incidence of side effects," Sznol said.

However, he argued that the survival benefits and the high cost of Yervoy outweigh the risks. "I have a lot of confidence in medical oncologists and their ability to manage side effects from treatment," Sznol said. "If later trials prove the efficacy is high enough, then the risk/benefit ratio is well worth it."

Drug manufacturer Bristol-Myers Squibb prices Yervoy at $30,000 per injection, which means a full four-dose course of therapy will cost $120,000.

"Whatever the cost might be, if you're getting this kind of efficacy, it might be a more cost-effective treatment than something that is less costly but much less effective," Sznol said.

Bristol-Myers Squibb helped fund both studies, the researchers report.

A third clinical trial presented at the meeting found that another new immunotherapy drug called MK-3475 also provided significant survival benefits to advanced melanoma patients.

MK-3475 targets the same receptor as nivolumab, one of the drugs used in the combination therapy trial.

More than 400 patients took part in this phase 1 trial, an early effort in the approval process. One-year survival rates were 74 percent in patients not previously treated with Yervoy, and 65 percent in people who had previously received Yervoy for their melanoma.

The FDA has granted MK-3475 a priority review designation, meaning the agency wants to speed up the application review. This trial was funded by the drug's maker, Merck.

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