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Posted by on Sep 8, 2013 in Melanoma | 0 comments

In a nutshell

This study investigated the long-term safety and efficacy of ipilimumab in patients with advanced melanoma.

Some background

Patients with advanced melanoma (cancer of the pigmented cells of the skin, called melanocytes, that has invaded beyond the skin or has spread to the lymph nodes or other organs of the body) often benefit from aggressive treatment that includes surgery and chemotherapy, radiotherapy or immunotherapy. Immunotherapy stimulates the patient’s own immune system to recognize and destroy cancer cells. Ipilimumab (Yervoy) is an immunotherapy drug that has been approved by the U.S. FDA for the treatment of patients with advanced melanoma. Ipilimumab works by activating the immune system to recognize, target and destroy melanoma cells. A previous study has shown that ipilimumab significantly improved survival in patients with advanced melanoma compared to a vaccine (gp100 vaccine) that also stimulates the immune system to destroy cancer cells. The aim of this study was to investigate the side effects and outcomes of the participants in a previous clinical trial who survived more than 2 years following treatment with ipilimumab, the gp100 vaccine or the two combined.  

Methods & findings

Out of the 676 patients with advanced melanoma included in the previous trial, 474 were followed up for at least 2 years after treatment with ipilimumab alone (95 patients), the gp100 vaccine alone (95 patients) or ipilimumab and the gp100 vaccine together(284 patients) and were included in this analysis. 20% of these 474 patients survived for more than 2 years after treatment. Results showed that in patients treated with ipilimumab alone, 25% survived for a minimum of 2 or 3 years. In patients who were given the combination treatment, 19% survived at least 2 years and 15% survived at least 3 years. 

The safety of ipilimumab in the patients who survived for at least 2 years was found to be similar to the safety of the entire study population of 676 participants. Of the participants who received ipilimumab, 11 participants had side effects related to the immune reaction such as bowel inflammation or skin discoloration. 

The bottom line

Overall, this study showed that ipilimumab treatment resulted in a 2 years or longer survival in one fifth of patients with advanced melanoma. In addition, it shows that the side effects associated with ipilimumab were generally well tolerated and similar to other treatment options.

The fine print

This study was funded by Bristol-Myers Squibb, the manufacturer of Yervoy.  

What’s next?

Talk to your doctor about ipilimumab, whether it is a good treatment option in your situation. 

Published By :

Annals of oncology

Date :

Aug 13, 2013

Original Title :

Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20).

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