WebMD Health News
Laura J. Martin, MD
June 6, 2011 -- Two new drugs that work in very different ways are being hailed as game changers in the treatment of patients with advanced forms of the deadly skin cancer melanoma.
New studies of the experimental drug vemurafenib and the newly approved drug Yervoy (ipilimumab) were published online in the New England Journal of Medicine and also presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The studies show that the two drugs can improve survival in patients who have had few treatment options in the past.
"In advanced melanoma we really haven't had good treatments," says Petra Rietschel, MD, PhD, who directs the Melanoma/Sarcoma Program at Montefiore Einstein Center for Cancer Care in New York City. She was not involved with the studies.
"There hasn't been anything, ever, that was proven to prolong survival, and now we have two drugs and probably more on the way," she says.
Close to 70,000 people in the U.S. are diagnosed with melanoma each year and about 8,700 patients die of the disease, according to the National Cancer Institute.
When the cancer has not spread it can be cured surgically by removing cancerous mole-like skin lesions. Once the cancer has metastasized, however, long-term survival drops to around 15%.
Vemurafenib, which is being developed by Genentech, targets a specific tumor mutation present in around half of patients with advanced melanoma known as BRAF.
The newly reported results included 675 patients with inoperable, metastatic melanoma with the tumor mutation treated with either the experimental drug or the standard chemotherapy drug dacarbazine.
Prior to Yervoy's approval in late March, dacarbazine was the only drug specifically approved for the treatment of advanced melanoma.
After three months of treatment, the vemurafenib-treated patients had a 63% reduction in the risk of death and a 74% reduction in disease progression or death compared to the patients treated with the chemotherapy.
Close to 50% of patients on the experimental drug responded to treatment, compared to around 5% of dacarbazine-treated patients.
About one in five patients taking vemurafenib developed non-melanoma skin tumors, and other common side effects included skin rashes, photosensitivity, and joint pain.
Study researcher Paul B. Chapman, MD, of Memorial Sloan-Kettering Cancer Center, tells WebMD that the hope is that some patients will respond to the drug for many years or even indefinitely.
He adds that a few patients from an earlier trial have been taking the drug for two years and continue to do well.
Chapman and colleagues are also investigating whether vemurafenib improves quality of life in very sick patients with advanced disease. Extreme pain, fatigue, weight loss, and bowel problems are common symptoms with late-stage melanoma.
"The hope is that we will be able to get these patients out of bed, off pain medications, and back into life with this drug," he says.
Genentech has submitted an application to the FDA to market vemurafenib for the treatment of advanced melanoma, and the agency is expected to make its ruling known by late October, Genentech spokesperson Krysta Pellegrino tells WebMD.
In a second study presented at the ASCO meeting, the combination of the immune-system targeting drug Yervoy and standard chemotherapy with dacarbazine was shown to improve patient survival when compared to chemotherapy alone.
Yervoy, marketed by Bristol-Myers Squibb Co., is approved for patients with inoperable or metastatic melanoma.
Although the average survival was just two months longer for patients in the combination portion of the study (11.2 months vs. 9.1), almost half of the combination-treated patients were alive after one year, compared to 36% of those who got the chemotherapy alone. Close to 21% were alive after three years, compared to 12% of patients treated only with dacarbazine.
Marc S. Ernstoff, MD, of New Hampshire's Dartmouth-Hitchcock Medical Center, says there are more drugs in the pipeline expected to target novel pathways in advanced melanoma.
"There are new agents coming in the next few years that will give us more tools in the toolbox of treatments for melanoma," he tells WebMD.
Chapman agrees, adding that Yervoy and vemurafenib mark the beginning of a new era of melanoma treatment.
"These new treatments will allow us to attack these tumors with a deeper understanding of what is driving them," he says.
SOURCES:Chapman, P.B. New England Journal of Medicine, June 4, 2011, online edition.Paul B. Chapman, MD, attending physician, melanoma/sarcoma service, Memorial Sloan-Kettering Cancer Center, New York.Marc S. Ernstoff, MD, hematology/oncology, Dartmouth Medical School and Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.Petra Rietschel, MD, PhD, director, Melanoma/Sarcoma Program, Montefiore Einstein Center for Cancer Care.Krysta Pellegrino, spokesperson, Genentech Corporate Relations.News release, American Society of Clinical Oncology.News release, Genentech.National Cancer Institute: "SEER Stat Fact Sheets: Melanoma."
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