Among patients with previously treated metastatic melanoma that carries a certain gene mutation, the targeted drug Zelboraf® (vemurafenib) resulted in a median overall survival of 16 months. This is a substantial improvement over what has been seen in the past among patients with this stage of disease. These results were published in the New England Journal of Medicine.

Of the more than one million new diagnoses of skin cancer each year, roughly 68,000 involve melanoma. More than 8,000 people die of melanoma each year in theUnited States. What makes melanoma so dangerous is that it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body.

In order to provide more individualized and more effective cancer therapy, much research has been focused on determining specific pathways involved in cancer cell growth or survival. The BRAF gene is known to play a part in cell growth, and mutations in BRAF are common in several types of cancer. Approximately half of all melanomas carry a specific BRAF mutation known as V600E. Zelboraf targets this mutation, and was approved in 2011 for treatment of certain patients with advanced melanoma that carries the V600E mutation.

To further evaluate Zelboraf in the treatment of advanced melanoma, researchers conducted a Phase II clinical trial among 132 patients with previously treated metastatic melanoma. The study was restricted to patients with melanomas that carried the V600E BRAF mutation. All study participants were treated with Zelboraf.

  • 53 percent of patients had a response to treatment (a reduction in detectable cancer)
  • Median progression-free survival (survival without a worsening of the cancer) was 6.8 months.
  • Median overall survival was almost 16 months. This is better than the 6- to 10-month median survival that was seen in the past among patients with metastatic melanoma.
  • The most common side effects of treatment were joint pain, rash, sensitivity to light, fatigue, and hair loss.
  • Squamous cell skin cancer was diagnosed in 26 percent of patients. Increased rates of squamous cell skin cancer have also been reported in other studies of Zelboraf, and patients should be aware of this risk. Squamous cell skin cancer usually does not spread to other parts of the body and can be treated with surgery.

These results provide additional evidence that Zelboraf improves outcomes among patients with advanced melanoma that carries a V600E BRAF mutation.

Reference: Sosman JA, Kim KB, Schuchter L et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. New England Journal of Medicine. 2012;366:707-714.

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