Drug is the first with FDA approval to treat skin and other pigmentation cancers that cannot be surgically removed or that have spread to other parts of the body
SCOTTSDALE, Ariz. — Feb. 20, 2024 — HonorHealth Research Institute plans to offer a potentially revolutionary T cell drug — approved Friday by the FDA to be safe and effective — to treat melanoma that cannot be surgically removed or that has spread to other parts of the body.
The drug AMTAGVI (generic name lifileucel) is manufactured by Iovance Biotherapeutics of San Carlos, Calif.
During clinical trials, the Research Institute was one of the few sites in the U.S. to offer this therapy before FDA approval as part of an expanded access program. The Institute plans to be one of only a few sites in the southwest U.S. to now offer the drug commercially to all qualifying melanoma patients. Others are in Los Angeles, San Francisco and Dallas.
The drug is the first T cell therapy to receive FDA approval for solid tumor cancer.
The drug is one of the new classes of T cell therapies being pioneered at the Institute that rely on new technologies that enhance the body’s own anti-cancer immune cells. In this case, tumor infiltrating lymphocytes, or TILs, are immune cells embedded in a tumor but, like exhausted soldiers, are no longer able to defeat cancer. However, because these immune cells can at least recognize the tumor, they still have value.
The process works like this: thousands of TILs are collected from a surgically removed melanoma tumor. These cells are fortified and multiplied by the billions in a laboratory. They are then infused back into the same patient from whom they were taken.
“The data suggests that this is likely the best option for patients with refractory melanoma and that it can provide long-time, durable disease control in some patients,” said Dr. Justin Moser, an associate clinical investigator at the Institute, specializing in melanoma.
TILs therapy is a one-time treatment
This one-time treatment was shown in clinical trials to have a nearly 30% response rate, more than triple the current standard-of-care chemotherapy response of less than 9%. In addition, nearly half of those who responded to this therapy continued to have a response for two years.
Dr. Michael Gordon, Chief Medical Officer of the HonorHealth Research Institute, said the initiation of TILs therapy at HonorHealth holds the promise of better outcomes for a variety of patients.
“This represents a major step forward in providing access to a novel therapy, not just for melanoma, but hopefully in other diseases,” said Dr. Gordon. “It uses immunotherapy in a way that potentially creates another avenue for durable responses.”
An estimated 97,000 Americans are diagnosed annually with melanoma, the fifth most common cancer among adults. Melanoma that spreads to other parts of the body, known as metastatic or advanced melanoma, has a five-year survival rate of only 35%.
Dr. Moser is also a clinical assistant professor at the University of Arizona College of Medicine-Phoenix and an adjunct faculty member at the Translational Genomic Research Institute (TGen).