Two New Drugs Increase Survival for Patients With Advanced or Metastatic Melanoma

ASCO Annual Meeting
June 5, 2011

Studies of two different drugs may change treatment for patients with advanced or metastatic melanoma. Advanced melanoma is stage IIIC or IV and cannot be removed with surgery, and metastatic melanoma has spread to other parts of the body. One study showed that the drug vemurafenib increased survival for patients with advanced melanoma when compared with chemotherapy. Vemurafenib is a type of targeted therapy, a treatment that targets the cancer's specific genes, proteins, or the tissue environment that contributes to cancer growth and survival. Specifically, vemurafenib targets mutations (changes) to a gene called BRAF, which is found in about half of all melanomas.

The 675 patients who participated in this study received treatment with vemurafenib or the drug dacarbazine (DTIC-Dome), the standard chemotherapy for melanoma. After around three months, the patients who received vemurafenib were 63% less likely to die from melanoma and 74% less likely to have the cancer worsen than the patients who received standard chemotherapy. In addition, melanoma growth slowed or stopped for 48% of the patients who received vemurafenib, compared with nearly 6% of the patients who received chemotherapy. These results were so promising that researchers recommended that the patients receiving dacarbazine switch to vemurafenib part way through the study.

In the other study on melanoma, researchers looked at ipilimumab (Yervoy) combined with dacarbazine as the initial treatment for metastatic melanoma. Ipilimumab is a type of immunotherapy, which is treatment designed to boost the body's natural defenses to fight cancer.

This study included 502 patients with metastatic melanoma who either received ipilimumab plus dacarbazine or a placebo (an inactive treatment) and dacarbazine. After three years, almost 21% of the patients who received ipilimumab and dacarbazine were alive, compared with around 12% of patients who did not receive this drug combination.

What this means for patients

Both of these drugs are major advances in the treatment of advanced or metastatic melanoma, one of the most deadly forms of cancer, and give patients with melanoma two new options for treatment that are better than the previous standard therapy.

“Vemurafenib is the first successful melanoma treatment tailored to patients who carry a specific gene mutation in their tumors, and could eventually join ipilimumab to become one of only two drugs available that improves overall survival in advanced cancers,” said Paul Chapman, MD, lead author of the study on vemurafenib and Attending Physician in the Melanoma/Sarcoma Service at Memorial Sloan-Kettering Cancer Center in New York City.

The side effects of vemurafenib include rashes, sensitivity to light, joint pain, and low-grade non-melanoma skin cancer. Because vemurafenib has not yet been approved by the U.S. Food and Drug Administration (FDA), it may not be available outside of clinical trials.

The ipilimumab study is important because it is the first time patients with metastatic melanoma have been able to survive for three years with therapy. As lead author Jedd Wolchok, MD, Director of Immunotherapy Clinical Trials and Associate Attending Physician at Memorial Sloan-Kettering Cancer Center, explains, “It's one of the advantages of immunotherapy. The immune system is a ‘living drug,' able to adapt itself to changes in the tumor that might otherwise lead to resistance when treated with chemotherapy or a pathway inhibitor.” Ipilimumab and dacarbazine side effects include increased liver enzymes, diarrhea, and a rash. Ipilimumab was recently approved by the FDA as a treatment for advanced melanoma.

Questions to ask your doctor

  • What stage of melanoma do I have?
  • What are my treatment options?
  • Will targeted therapy or immunotherapy be part of my treatment plan?
  • What treatment plan do you recommend? Why?
  • What are the side effects of this treatment? How can these be managed?

For More Information

Guide to Melanoma

Understanding Targeted Treatments

Understanding Immunotherapy

Clinical Trials

Drug Improves Survival for Patients With Advanced Melanoma