The FDA has granted accelerated approval to a new type of cellular therapy for use in people who have skin cancer which has spread to other parts of the body.
“This is a major advance for patients with metastatic melanoma,” said Daniel Olson, MD, medical oncologist at the University of Chicago Cancer Center, which is one of the locations offering the therapy. “Currently, our available therapies can offer control or cure for just over 50% of patients with advanced melanoma, leaving many patients without adequate treatment options,” added Dr. Olson.
The cell-based treatment is known as a “tumor infiltrating lymphocyte” (TIL) therapy and it’s production is a complex several step process started by extracting immune cells from a patient’s tumor during surgery. The cells are then genetically analyzed to identify those that are are naturally primed to attack the tumor, expanding these cells in the lab to boost their numbers, before injecting them back into the patient to tackle the cancer.
The therapy called lifileucel was developed by Iovance Biotherapeutics, Inc. and the clinical trial leading to the accelerated approval analyzed the therapy in over 150 patients for whom previous treatments had been unsuccessful.
“After standard therapies (immune checkpoint inhibitors, BRAF-targeted therapies), there are essentially no current therapies likely to offer long-term remission for patients with melanoma. Lifileucel showed that nearly a third of patients can achieve control with this therapy. While this therapy doesn’t benefit everyone, it now offers the chance of long-term remission for some patients, which is something we could not say with our current therapies,” said Dr. Olson.
Because of the several step process involved in developing the personalized therapy, it comes with a hefty price tag of $515,000 per patient, according to the interim CEO and President of Iovance, Frederick Vogt speaking on a conference call.
“Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients,” said Vogt in a company press release. “We are continuing our development efforts to address additional unmet medical needs in patients with solid tumor cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers,” Vogt added.
A different type of cellular therapy called CAR T cells have been very successful in treating people with some types of blood cancer which has not responded to conventional treatments such as chemotherapy. Despite these notable successes, particularly in children with leukemia, so far, their success has been mostly limited to blood cancers, with solid tumors posing more of a challenge.
Further investigations featuring the TIL therapy are ongoing, including combining it with other immunotherapies for metastatic melanoma, as well as testing the therapy in other types of cancer such as lung cancer.
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