First cell therapy for solid tumors heads to the clinic: what it means for cancer treatment
Therapy built on tumour-infiltrating lymphocytes is now being prepared for at least 20 people in the United States with advanced melanoma. More than 35 years after it was invented, a therapy that uses immune cells extracted from a person’s own tumour is finally hitting the clinic. At least 20 people with advanced melanoma have embarked on treatment with what is called tumour-infiltrating lymphocytes (TILs), which target and kill cancer cells. The regimen, called lifileucel, is the first TIL therapy to be approved by the US Food and Drug Administration (FDA). It is the first immune-cell therapy to win FDA approval for treating solid tumours such as melanoma. Doctors already deploy immune cells called CAR (chimeric antigen receptor) T cells to treat cancer, but CAR-T therapy is used against only blood cancers such as leukaemia.
The FDA granted approval on 16 February to lifileucel, sold as Amtagvi. The approval is a great accomplishment, He says that it will pave the way for TILs to be used to treat other cancers, including lung and pancreatic tumours, shortly. After a person’s tumour is removed, surgeons send tissue samples to a laboratory that isolates TILs from them and grows the TILs for three weeks until they’ve multiplied into billions of cells. Before the TILs are reinfused back into the treated person, the recipient is given chemotherapy and an immune chemical called interleukin-2 (IL-2) that temporarily kills immune cells to make room for the TILs. For now, lifileucel can be used only as a last-line treatment in people with certain forms of advanced melanoma that haven’t responded to other treatments. But Iovance and others are currently testing lifileucel as a first-line treatment against melanoma. Some evidence suggests that it might be even more effective as a first- or second-line treatment before an aggressive treatment can harm the TILs in tumours.
In Iovance’s trial testing lifileucel in 153 people with melanoma, tumours shrank in 31 percent of the participants. Furthermore, in a second trial conducted in Denmark, 20% of patients receiving TIL therapy experienced complete remission, compared to 7% of patients receiving a different medication. According to Amod Sarnaik, a surgical oncologist who oversaw Iovance’s trial and works at the Moffitt Center in Tampa, Florida, solid tumors typically develop resistance to therapies like chemotherapy. However, Sarnaik claims that often enough “brute force” will defeat the cancer if the majority of the tumor is removed and billions of TILs are infused. The best TILs are then “remembered” by the immune system, which enables it to rapidly expunge them if the cancer returns.
The majority of the adverse effects of the therapy, including fevers and anemia, are related to the IL-2 and chemotherapy administered to patients to get them ready for TIL infusion. TILs target not only tumor cells but also healthy cells. This can lead to autoimmune diseases like vitiligo, where TILs attack pigment cells in the skin, causing discoloration. TILs are naturally occurring, uniquely human cells, much like CAR T cells. However, while CAR T cells are genetically modified to target particular antigens on cancer cells, the specific antigens that each individual’s TILs target are unknown, though it essentially doesn’t matter as long as they are effective for that person. For each patient, the medication is essentially different. The FDA approved Iovance’s method for multiplying TILs and administering them to cancer patients because it is not feasible for the agency to evaluate each patient’s set of TILs. Additionally, since TILs arise spontaneously, businesses can only patent their methods not the cells as a whole. For those of us attempting to devise novel approaches to enhance the procedure, this is welcome news.
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