New skin cancer drug brings hope

By Dr. Ananya Mandal, MDJun 5 2011

A new drug for the dreaded cancer melanoma is in the horizon. It is called Vemurafenib. This is a class of drug that cancer researchers are applauding today at the American Society of Clinical Oncology's annual meeting in Chicago.

“Doctors were told they are on the edge of a new era, and that several of the latest breakthroughs could bring about the most significant changes to cancer survival”, Dr. Lynn Schucter, a cancer researcher said. The drug vemurafenib is receiving much of the attention. Dr. Len Lichtenfeld of the American Cancer Society, said the drug targets genetic cell mutation, which affects about half of those with melanoma.

Results from the studies have shown that melanoma patients who were given the drug were said to be alive and no longer needing chemotherapy. Melanoma is the most common form of cancer, affecting approximately 70,000 new people each year.

Melanoma kills nearly 9000 people annually each year. But Dr. Paul Chapman with Memorial Sloan Kettering Cancer Center and the leader of the vemurafenib study, said he believed the new findings bring a renewed sense of hope for one of the most deadly forms of cancer.

The drug, vemurafenib, is designed to treat patients who have what’s known as a BRAF gene mutation, which is found in about half of metastatic melanoma cases and is thought to promote cancer cell growth.

The clinical trial with vemurafenib involved 675 patients around the world with inoperable, advanced melanoma and the gene mutation. Researchers compared vemurafenib with Decarbazine, another chemotherapy drug used to treat skin cancer. The study found that of the patients who were given the vemurafenib pills twice a day, 84 percent were alive after six months. The drug also shrank tumors in 48 percent of patients, compared to 5 percent in those taking dacarbazine.

“To have 84 percent of patients on Vemurafenib still alive was astounding and statistically, highly significant,” Chapman said. Vemurafenib could be approved and on the market in six months experts added. Researchers reported the results Sunday in Chicago at the annual meeting of the American Society of Clinical Oncology.

The most common side effects in the study were skin rashes, joint pain and light sensitivity. In addition, 18 percent of patients developed an easily treatable non-melanoma skin cancer. Bristol-Myers Squib paid for the study and many of the researchers consult or work for the company.

Another melanoma success was seen with the collaboration of Roche and Bristol-Myers Squib's melanoma fighting drug, Yervoy or ipilimumab, which works by stimulating the body's own immune system to fight cancer.

In the trial, more than 500 patients were randomly assigned to receive either a combination of ipilimumab and dacarbazine or decarbazine and a placebo. Those who received ipilimumab lived 11 months on average, compared to 9 months in the control group. They were also more likely to be alive after three years, though serious side effects were more common, researchers reported.

Yevoy won Federal Drug Administration approval in March and became the first drug to show signs of success for treating metastatic melanoma. The drug was shown to increase survival rates for melanoma patients by a third. It is set to cost $120,000 for a complete course of treatment, which consists of four infusions given over a three-month period, Bristol-Myers said in a statement back in March.