New FDA-approved immunotherapy targets melanoma

May 14, 2019 | by Jenny Peters

Treatment of the deadliest form of skin cancer, melanoma, just took “a huge leap forward,” according to Morganna Freeman, D.O., assistant clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope, with the Food and Drug Administration’s approval of three new postsurgical immunotherapy drugs for the disease.
 
Morganna Freeman Morganna Freeman, D.O
Melanoma occurs when skin cells mutate, multiply rapidly and form malignant tumors. After patients with advanced-stage melanoma have surgery to remove the cancer, until now they were faced with an unpleasant reality.
 
“Over a five-year period, the chance of that melanoma coming back can be anywhere from 50% to 70%," Freeman explained. "There will be 180,000 cases of melanoma diagnosed this year in the United States, and 90,000 of those will be what we call invasive melanoma, meaning the cancer gets into the deeper layers of the skin — and potentially also into the neighboring lymph nodes." Those patients with a higher stage of disease also have a high risk of relapse, she said.
 
That reality of relapse has changed dramatically since the Food and Drug Administration (FDA) approved two treatments to prevent melanoma recurrence in 2018 and an additional one in 2019. "It's a breakthrough in therapy," she said. "One drug is called Opdivo, the other is called Keytruda; both are immunotherapies, given as an IV treatment. Immunotherapy is a way to strengthen the body's own natural defenses against cancer. So we're using a medicine to stimulate a person's individual immune system."
 
The other recently approved FDA drug is used as a targeted therapy, which Freeman explains is "used to work against a certain mutation that some melanomas carry. So about half of all melanomas will grow because they have a gene mutation called BRAF. BRAF mutations can cause a normal mole to grow into a melanoma, and can also enable that melanoma to spread quickly. BRAF mutations can lead later to bad things, like advanced cancer. This BRAF therapy is given as a pill."
 
The oncologists who work in melanoma treatment have struggled until now to find ways to help patients avoid a relapse of the cancer, but up until these three drugs were approved, nothing actually worked. "In years prior, the only effective therapy that we had for melanoma was Interferon, which a lot of patients didn't tolerate because of the side effects. Interferon caused a lot of problems with depression and liver inflammation and weight loss. We also found that Interferon wasn't really that good of an insurance policy in terms of preventing melanomas, because those patients would still get recurrent disease at some point. Melanoma, like other cancers, can become fatal is when it spreads to other, distant organs," Freeman said.
 
The results of the studies leading up to FDA approval, as well as of the patients being treated since the drugs came into the doctor's arsenal, are incredibly encouraging.
 
What we've seen with each of these drugs is that patients who take them after surgery have a higher likelihood of being melanoma-free, cancer-free, after a year of treatment. We've found that even patients who were at the highest risk of melanoma coming back, they have been cancer-free up to two years later," Freeman said.
 
"We know that the highest likelihood of someone relapsing from their cancer is within that two years, so for us, seeing that there are patients alive, doing well, and still cancer-free means this is an enormous benefit to patients who didn't have that option before."
 
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