New Category of Cancer Therapies Uses Immune System to Combat Tumors

( — The Food and Drug Administration (FDA) has recently approved the use of a new kind of cancer treatment called Amtagvi, which uses tumor-infiltrating lymphocytes (TIL). These treatments are intended for patients with metastatic melanomas who have already tried other treatments without success. This form of cancer is considered very dangerous, with low survival rates at later stages.

Iovance Biotherapeutics is the California-based biotech company that developed Amtagvi. They state that their TIL treatment is meant for use in patients who have melanoma that cannot be removed surgically or has already spread to other parts of their bodies. TILs have been used only in several academic cancer centers for decades now, but Amtagvi is the first to get the FDA approval needed. Several other viable TIL candidates are even now waiting in the wings for eventual use against a variety of cancers.

TIL therapy involves extracting tumor-infiltrating lymphocytes that are within the tumors and then replicating them in a lab setting. Then, when there are exponentially more of those immune cells, they infuse them back into the patient. In the phase 2 trial, 31.5% of patients responded to the treatment. A more recent NIH study showed responses in 56% of the patients with TIL therapy. In that same NIH study, 24% of patients experienced a complete disappearance of their melanomas, no matter where they were located.

Although the FDA has already rushed approval of Amtagvi based on the amazing results of their Phase 2 trial, Iovance Biotherapeutics is going ahead with their more intensive Phase 3 trial to verify the benefits of the TIL therapy. While promising treatments for aggressive cancers such as metastatic melanomas are good news, some are concerned at how expensive these new TIL treatments are. They will cost about $515,000 per patient, making them the most expensive cell-based therapies in the United States. Brian Gastman, Iovance’s executive vice president of medical affairs, points out that while it is expensive and time-consuming at 22 days, the TIL course is a one-time treatment, which may be preferable to others that have to continue over longer periods of time.

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