The FDA Approval of TIL Therapy and What it Means for Advanced Melanoma [Video]

An exciting new development in melanoma treatment is the recent FDA approval of Lifileucel (AMTAVGI) therapy, which harnesses the power of the body’s own immune cells to recognize and attack melanoma cells.

In this webinar, hosted by Samantha Guild, JD, the esteemed President of AIM at Melanoma, we explore the implications of this newly-approved treatment for melanoma care. Our guest, Allison Betof Warner, is a foremost authority on TIL therapy.

From the National Cancer Institute:

In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses immune cells called tumor-infiltrating lymphocytes, or TILs. Announced on February 16, 2024, the agency’s decision also makes lifileucel the first cellular therapy to be approved for a solid tumor, the skin cancer melanoma.

The agency’s accelerated approval covers the use of lifileucel for people with advanced melanoma that has gotten worse after treatment with certain immunotherapy drugs or targeted therapies.

As is the case with CAR T-cell therapy, another type of cellular therapy, lifileucel is made using a patient’s own T cells. And with both therapies, the cells are collected at the hospital where the patient is being treated but are sent away to be manufactured into the final treatment.

But there’s a key difference between TILs and CAR T-cell therapies.

For the approved CAR T-cell therapies, the T cells are collected from a patient’s circulating blood. For TIL therapy, by contrast, the T cells are collected from the patient’s tumor.

Lifileucel’s approval was based on findings from a clinical trial sponsored by Iovance Biotherapeutics. Among more than 70 participants who were treated with the lifileucel dose ultimately approved by FDA, nearly one-third had at least some reduction in the size of their tumors (a tumor response), with tumors disappearing completely (a complete response) in several participants.

Moreover, about 40% of those whose cancer responded to lifileucel still had no progression of their cancer a year after receiving the one-time infusion treatment.

TIL therapy was pioneered by Steven Rosenberg, M.D., and his colleagues in NCI’s Surgery Branch. In the late 1980s, Dr. Rosenberg led the first-ever clinical trials of TIL therapy, showing that it could shrink tumors in people with very advanced melanoma. (Dr. Rosenberg was recently given the nation’s highest award for technology and innovation for his work on immunotherapy, including the development of TIL therapy.)

Over the ensuing years, the NCI researchers further refined the process for manufacturing and delivering TIL therapy. In 2011, NCI entered into a cooperative research agreement with Iovance to further develop this particular TIL therapy, including conducting larger clinical trials and developing a manufacturing infrastructure, paving the way for FDA approval.

It’s been a long time coming, Dr. Rosenberg acknowledged. The new approval “is a big step,” he said, one which demonstrates that “cellular therapy is joining the mainstream of cancer treatment.”