SkinCancerNet Spotlight Article
New Drugs for Late-Stage Melanoma


Drugs that treat late-stage melanoma are making headlines. On this page, you’ll find answers to some common questions about three of these drugs:

  • Ipilimumab (pronounced ip-ee-LIM-yoo-mab)
  • Peginterferon alfa-2b
  • Vemurafenib (pronounced vem-yoo-RAF-en-ib)

Do these drugs cure melanoma?
No. These drugs do, however, offer patients who respond more time. Here is what researchers found during clinical trials:

  • Ipilimumab: The patients who received only ipilimumab and responded to it lived about 10 months longer. For a few patients given ipilimumab, the response was dramatic. A few patients have had no signs of cancer for as long as 6 years.
  • Peginterferon alfa-2b: The patients who responded to this drug stayed in remission (no signs of cancer) for 9 months longer than patients who did not receive the drug.
  • Vemurafenib: On average, patients who responded lived 6.2 months without the melanoma getting worse.

Who can take these drugs?
These drugs may be an option for some patients with advanced melanoma:

  • Ipilimumab: Approved for patients ages 18 and older who have melanoma that is in stage III or stage IV and cannot be removed with surgery.
  • Peginterferon alfa-2b: Approved for patients aged 18 and older who have stage III melanoma. Patients take this drug after undergoing surgery to remove lymph nodes that contain cancer. The drug should be started within 84 days of surgery.
  • Vemurafenib: Patients who are eligible for vemurafenib have metastatic melanoma and have been diagnosed with a BRAF V600 mutation.

While the FDA established these guidelines, this does not mean that a drug is the right choice for every patient who fits one of the above descriptions. Your oncologist, doctor who specializes in cancer treatment, or your dermatologist will consider many factors before prescribing one of these drugs.

What do these drugs do?
Each drug works a bit differently:

  • Ipilimumab: Blocks a specific molecule, which may allow the patient’s body to recognize, target, and attack melanoma cells.
  • Peginterferon alfa-2b: Helps the body to find and destroy stray melanoma cells not removed during surgery, which may delay the melanoma from returning.
  • Vemurafenib: Targets the BRAF mutation, which may stop the cancer cells from continuing to grow uncontrollably and the cancer from getting worse.

Note: About half of the patients diagnosed with late-stage melanoma have a mutation in a gene known as BRAF. This mutation causes their cells to grow uncontrollably and cancer to form.

How many patients respond to the drugs?
One of the drawbacks is that not every patient responds, as the following data shows:

  • Ipilimumab: In the clinical trials, only 10.9% responded to the drug.
  • Peginterferon alfa-2b: In the clinical trial, one group of patients received this drug after surgery to remove the lymph nodes. The other group did not receive any additional treatment. There was not a significant difference in remission (no signs of cancer) between these two groups. At 4 years, 45.6% of patients who received the drug had no signs of cancer and 38.9% of patients who had no additional treatment had no signs of cancer.
  • Vemurafenib: At the end of 6 months, 84% of the patients who received this drug were alive. Other patients in the clinical trial received chemotherapy, and 64% of these patients were alive at the end of 6 months.

What is the benefit of taking one of these drugs?
Two of these drugs,
ipilimumab and vemurafenib, give patients who respond a few more time. For a few patients given ipilimumab, the response was dramatic. A few patients have had no signs of cancer for as long as 6 years.

Peginterferon can prevent the melanoma from spreading beyond the lymph nodes.

How do patients take these drugs?

  • Ipilimumab: A healthcare provider gives this drug through an IV line. Each infusion takes about 90 minutes. The standard dose is 4 infusions, with an infusion given once every 3 weeks. The dose can vary from patient to patient.
  • Peginterferon alfa-2b: A patient injects this drug under the skin (subcutaneous injection). Before a patient receives this drug, a nurse or other healthcare provider shows the patient how to prepare and measure the medicine and how to inject it.
  • Vemurafenib: In clinical trials, patients are taking a pill twice a day.

What are the side effects?
All medicines have potential side effects. Before taking any medicine, you should talk with your doctor about the side effects. If you decide to take one of these medicines, you will receive a guide that describes the possible side effects.

Research continues
For the first time, patients with advanced melanoma have treatment that may prolong their life. One drug is giving patients longer remissions. These successes are fueling further research. New drugs are already undergoing clinical trials.

References:
Chapman PB, Hauschild A, Robert C et al. Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation. N Engl J Med.

Eggermont AM, Suciu S, Santinami M et al. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet 2008; 372: 117-26.

Hodi FS, O'Day SJ, McDermott DF et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010; 363: 711-23.

Schwartz JD. Diarrhea from ipilimumab in melanoma. N Engl J Med; 363: 2262; author reply -3.

U.S. Food and Drug Administration. “FDA approves new treatment for a type of late-stage skin cancer.” News release issued March 25, 2011. Last accessed April 26, 2011. Available at www.fda.gov/newsevents/newsroom/pressannouncements/ucm1193237.htm.

U.S. Food and Drug Administration. “Medication Guide: Ipilimumab. Last accessed June 2, 2011. Available at http://packageinserts.bms.com/medguide/medguide_yervoy.pdf.

U.S. Food and Drug Administration. “Medication Guide: Peginterferon alfa-2b.” Last accessed June 2, 2011. Available at www.fda.gov/downloads/Drugs/DrugSafety/UCM249397.pdf.

Wolchok JD, Weber JS, Hamid O et al. Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun; 10: 9


All content solely developed by the American Academy of Dermatology

Late-Stage Melanoma
A patient has late-stage melanoma when the cancer spreads. When the cancer spreads to a lymph node closest to the melanoma, the patient has stage III melanoma. When melanoma spreads beyond the closest lymph node, a patient has stage IV melanoma.

 
 

 

 

 

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Page last updated 7/22/11

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