- Human Biospecimens
- For Researchers
- For Biospecimen Contributors
- For Patients
June 22, 2016
Monday of this week marked the first day of summer, a time when many of us are outdoors, enjoying the warmth of the sun. Of course, sun safety is paramount at this time of year, when skin is regularly exposed to potentially harmful UV rays. But despite strong awareness efforts, the incidence of the skin cancer known as melanoma has continued to rise, with malignant melanoma claiming the lives of more than 10,000 Americans per year and more than 22,000 Europeans. However, a new type of treatment, immunotherapy, has presented hope for those affected, with the US FDA approving a combination of these drugs in September of last year for patients with malignant melanoma. But what about our friends across the pond in Europe? As of last week, the outlook is good.
On April 1, the European Medicines Agency (EMA) licensed the combination therapy of nivolumab and ipilimumab for patients with malignant melanoma, and last week the UK’s National Institute for Health and Care Excellence (NICE) announced that patients in England and Wales would be the first Europeans to benefit from the drugs. The combination therapy represents the first-ever drug combination to receive approval for this particular disease. Clinical trials have shown that the treatment results in an increase in patients’ objective response rate, prolonged response durations, and increased improvement in progression-free survival.
Nivolumab and ipilimumab are drugs known as ‘checkpoint inhibitors,’ that target the body’s immune system so that it is able to seek out and attack cancer cells. Individually, ipilimumab targets a molecule on immune cells called CTLA-4, while nivolumab targets another call called PD-1. Although there is evidence that individual treatments are effective, clinical trials proved that the combination of the two ultimately showed a higher 53 percent response rate. Immunotherapy is a subset of personalized medicine, a model of care that focuses on treating patients based on their individual make-up, since not all patients react to treatments or disease the same way.
While only three checkpoint inhibitors are currently approved in the United States, intensive research is underway to find additional treatments and further uses for the inhibitors that are already approved. As discussed in our first Specimen Spotlight, providing researchers with human biospecimens from patients who have been treated with checkpoint inhibitors is critically important to this research. We are hopeful that given the efforts behind personalized medicine, and more specifically, immunotherapy as it relates to cancer, we will continue to see breakthroughs and approvals such as this one moving across continents and patients.