Brown Cancer Center Clinical Trial Leads to FDA Approval of “Game Changing” Cancer Treatment

LOUISVILLE, KY – UofL Health – Brown Cancer Center’s success with TIL cell therapy (Tumor Infiltrating Lymphocytes) is poised to reshape cancer treatments nationwide. This follows FDA approval of the cell product AMTAGVI™ (lifileucel), developed by Iovance Biotherapeutics, for patients diagnosed with advanced melanoma, whose disease progressed following initial treatment with an immune checkpoint inhibitor and, if appropriate, targeted therapy. Previously there have been no FDA-approved treatment options for these patients. The initial FDA approval is specific to metastatic melanoma, but an expansion to other cancers is anticipated in the future.

The Brown Cancer Center is one of only a few authorized treatment centers in the U.S. that participated in the TIL clinical trials, was a lead enrolling center, and had patients traveling to Louisville, KY, from all over the United States. The Brown Cancer Center’s Director, Jason Chesney, M.D., Ph.D., served as a principal investigator of multiple TIL clinical trials and was named as the lead author of a major TIL publication that supported the FDA approval.

“AMTAGVI is a TIL cell therapy that significantly extends the lives of many patients who have cancers resistant to existing therapies,” said Dr. Chesney. “AMTAGVI is a game changer, and the FDA approval expands access to more centers and more patients.  I’m proud that the Brown Cancer Center is at the forefront of testing this innovative therapy and look forward to sharing our expertise with other centers nationwide.”

The AMTAGVI cell product is a one-time, personalized TIL cell therapy that uses immune cells called T cells recovered from a patient’s tumor tissue to produce billions of cancer-specific T cells. Following a single infusion, the TILs migrate to tumors throughout the body where they recognize individualized cancer antigens and cause cancer cell death. Importantly, based on the long-term survival of many patients who receive AMTAGVI™, TILs can continue this mission for years.

Val Snapp of Nashville, Tenn. credits AMTAGVI (lifileucel) for saving her life. When treatment options for her melanoma diagnosis seemed to be exhausted, doctors said she did not have long to live. But Dr. Chesney, and UofL Health – Brown Cancer Center, gave her hope. She was treated with AMTAGVI and is now cancer free.

Lindsey Wainwright of Knoxville, Tenn., was diagnosed with stage IV melanoma in September 2015 at age 33 with a prognosis of two to seven months given. She came to Brown Cancer Center almost two years later for a TIL clinical trial. She is now cancer free and graduated this year from the University of Tennessee with a Masters of Architecture.Lindsey Wainwright TILs patient

With the approval of the FDA, AMTAGVI has become the first and only TIL therapy approved for patients with advanced melanoma, as well as the first one-time cell therapy for solid tumor cancer. The Brown Cancer Center completed its first successful TIL procedure in 2016 and has expanded its beneficial use to clinical trials in other cancers, including lung cancer, cervical cancer, and head and neck cancer.

“The Brown Cancer Center has one goal – to end cancer,” said Dr. Chesney. “As more cancer centers across the country begin to implement TIL programs, we will be saving more lives and will be one step closer to achieving this goal.”

More information on TIL therapy and UofL Health – Brown Cancer Center is available on UofLHealth.org.

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UofL Health is a fully integrated regional academic health system with nine hospitals, four medical centers, Brown Cancer Center, Eye Institute, nearly 200 physician practice locations, and more than 1,000 providers in Louisville and the surrounding counties, including southern Indiana. Additional access to UofL Health is provided through a partnership with Carroll County Memorial Hospital. Affiliated with the University of Louisville School of Medicine, UofL Health is committed to providing patients with access to the most advanced care available. This includes clinical trials, collaboration on research and the development of new technologies to both save and improve lives. With more than 14,000 team members – physicians, surgeons, nurses, pharmacists and other highly-skilled health care professionals, UofL Health is focused on one mission: to transform the health of communities we serve through compassionate, innovative, patient-centered care.

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