ASCO Annual Meeting
June 2, 2014
An early study shows that half of patients with advanced melanoma who received a combination of ipilimumab (Yervoy) and nivolumab, an investigational medication, were alive almost three and a half years later (40 months). That is nearly double the amount of time reported in earlier studies that used either drug by itself. Both ipilimumab and nivolumab are immunotherapies, which is a type of treatment designed to boost the body's natural defenses to fight the cancer. However, each drug targets a different checkpoint found on T-cells, a type of white blood cell that directly helps the immune system fight disease.
As part of this study, 53 people with stage III or IV melanoma that could not be removed with surgery received ipilimumab and nivolumab. According to the researchers, the combination treatment caused melanoma to shrink quickly and substantially. Within about nine months, 42% of the participants had the number of tumors decrease by more than 80%. This effect appears to be long-lasting, with 18 of the 22 responses (82%) continuing at least until the time when these data were collected. Overall, 22 out of 53 study participants (41%) had some benefit from this treatment, and nine (17%) experienced a complete remission, which means there were no signs of melanoma after treatment.
The number of side effects caused by the combination treatment was higher than the number reported in other studies that used either ipilimumab or nivolumab by themselves. However, most of these side effects were manageable and reversible.
What this means for patients
“Just a few years ago, median survival for patients diagnosed with advanced melanoma was as little as a year or less, and only approximately 20% to 25% survived two years, so it’s truly remarkable that we’re seeing a median survival of over three years in this trial,” said lead study author Mario Sznol, MD, a professor of medical oncology at Yale School of Medicine in New Haven, CT. “While we’re encouraged by what we’re seeing with the use of these two drugs together, this trial was small, so a randomized phase III trial will be important to validate our initial results.”
Ipilimumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of stage IV melanoma and for stage III melanoma that cannot be removed with surgery. However, nivolumab is not currently FDA-approved. If you have been diagnosed with advanced melanoma, talk with your doctor about the treatment options available to you, including clinical trials, and how those options will affect the length and quality of your life.
Questions to ask your doctor
- What stage of melanoma do I have?
- What are my treatment options?
- What clinical trials are open to me? Where are they located, and how do I find out more about them?
- What treatment plan do you recommend? Why?
- What is my chance of recovery?
- If I’m worried about managing the costs related to my cancer care, who can help me with these concerns?