Patients with advanced melanoma have lived as long as ten years when treated with the immunologic therapy Yervoy® (ipilimumab), according to pooled data presented at the ESMO 2013 Congress of the European Society for Medical Oncology in Amsterdam.
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. Melanoma is dangerous because it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body.
Immunotherapy refers to treatments that activate the immune system to attack cancer cells. Yervoy, a drug approved in 2011 for the treatment of advanced melanoma, 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.
Researchers pooled data from 12 clinical trials (two phase III clinical trials, eight phase II trials, and two observational studies) that included a total of 1,861 patients (1,257 previously treated and 604 treatment-naïve). They also conducted further analysis of an additional 2,985 patients from an expanded access program.
Among the initial 1,861 patients, the data showed a three-year survival of 22 percent, a seven-year survival of 17 percent, and no deaths beyond seven years. Analysis of the additional 2,985 patients showed a three-year overall survival of 21 percent.
Primary analysis of the 1,861 patients showed a median overall survival of 11.4 months. Subgroup analyses showed that treatment-naïve patients had a median overall survival of 13.5 months and a three-year survival of 26 percent; previously treated patients had a median overall survival of 10.7 months and a three-year survival of 20 percent. Combined analysis of all 4,846 patients showed a median overall survival of 9.5 months.
The researchers concluded that patients with advanced melanoma treated with Zervoy experienced a survival plateau at three years that extended through at least 10 years. This could represent a paradigm shift in the treatment of advanced melanoma—historically a fatal disease, it could now be treated as a chronic condition.
Schadendorf D, Hodi FS, Robert C, et al. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in metastatic or locally advanced, unresectable melanoma. Presented at the 38th Congress of the European Society for Medical Oncology (ESMO), Amsterdam, Netherlands, September 27-October 1, 2013. Abstract LBA24.
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