The first trial of the immunomodulator Yervoy® (ipilimumab) conducted in patients with stage III melanoma appears promising, demonstrating an improvement by delaying cancer recurrence and improving survival.
Skin cancer is the most common form of cancer in the United States, with more than one million new cases each year. Skin cancer is often divided into two broad categories: melanoma and non-melanoma. Non-melanoma skin cancer refers to several different types of skin cancer, but the most common types are basal cell carcinoma and squamous cell carcinoma.
Melanoma is less common than non-melanoma skin cancer, but tends to be much more aggressive. 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 the United 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. Melanoma can occur anywhere on the body. The first signs of melanoma may be a mole that changes in appearance, bleeds, or has more than one color or an irregular shape.
Standard treatment for stage III melanoma typically involves surgery to remove the cancer. Because many patients will experience a recurrence following treatment with surgery alone, doctors have been searching for an appropriate therapy to be administered after surgery to improve outcomes.
Yervoy® is a monoclonal antibody approved for the treatment of advanced melanoma. Yervoy® targets a molecule known as CTLA4. CTLA4 is found on the surface of T cells and is thought to inhibit immune responses. By targeting this molecule, Yervoy® may enhance the immune system’s response against tumor cells. Yervoy® was approved in March 2011 for the treatment of melanoma that has spread to other sites or cannot be surgically removed.
In the current study a total of 951 patients over 18 years of age who underwent complete surgical removal of a stage III cutaneous melanoma were treated with either a placebo or Yervoy® and directly compared. Treatment with Yervoy® was every 3 weeks for 4 doses, then every 3 months for up to 3 years until completion, melanoma recurrence, or unacceptable toxicity.
At a median follow-up of 2.7 years from the initiation of this phase III trial, Yervoy® when utilized as adjuvant therapy both reduced the risk of melanoma recurrence and improved the duration of survival. Overall 46% of patients treated with Yervoy® were free of disease recurrence compared to 35% of patients treated with placebo. Patients survived without cancer recurrence an average of 26.1 months when treated with Yervoy® compared to only 17.1 months for placebo.
The demonstration that Yervoy® improves patient outcomes when used to treat stage III melanoma is the first significant advance in the management of earlier stage melanomas in years. Additional clinical trials will undoubtedly evaluate Yervoy® in stage II patients and explore combination with other novel melanoma therapies to see if outcomes can be further improved.
Reference: J Clin Oncol 32:5s, 2014 (suppl; abstr LBA9008)
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