Novel therapy initiated in first patient with drug-resistant melanoma skin cancer

For the first time, an HonorHealth patient has been treated with tumor infiltrating lymphocytes, or TILs, at HonorHealth Research Institute.

The patient received TILs on April 5 to treat refractory melanoma skin cancer; refractory meaning their cancer has always been resistant to treatment or became resistant during a previous treatment.

TILs are immune cells imbedded in a tumor that are fighting a losing battle. They are few in number and essentially become exhausted, allowing the cancer to progress.

But because these immune cells recognize the tumor, they still have value.

Hope is here

Justin Moser, MD, an associate clinical investigator specializing in melanoma at HonorHealth Research Institute, explained the elaborate process of using TILs to fight cancer.

A melanoma tumor of at least 1.5 cm is surgically removed and sent to a laboratory where it is broken down into individual cells. The TILs are removed and over six weeks are enhanced by being treated with interleukin 2, making them better able to fight the cancer. They are then multiplied, resulting in billions of energized immune cells which are given intravenously to the patient.

Prior to the introduction of the enhanced TILs, the patient is treated with a combination chemotherapy of fludarabine and cyclophosphamide for five to seven days. The TILs are then re-introduced, and the patient receives a three-day boost of high-dose interleukin 2.

HonorHealth Research Institute is among a handful of sites nationwide given permission to use TILs through an Expanded Access Protocol, sponsored by Iovance Biotherapeutics, which manufactures the TILs being used at HonorHealth.

For patients with refractory melanoma, clinical trials have shown that TIL therapy produces a nearly 30% response rate, or more than triple the rate of the current standard-of-care chemotherapy, ipilimumab, which has an average response rate of 8.6%. In addition, past studies have shown that some patients who respond to TIL therapy may continue to have a response for as long as three years following this one-time treatment.

“The data suggests that this is likely the best option for patients with refractory melanoma, and that it can provide durable disease control in some patients,” said Dr. Moser, who also is 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).

“We’re currently preparing to offer this as a standard-of-care treatment, if and when it is approved by the FDA,” he added.

A second HonorHealth refractory melanoma patient is being scheduled for TIL therapy.

Michael Gordon, MD, 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 based on anticipated new clinical trials in other diseases.

“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 applies immunotherapy in a way that potentially creates an avenue for durable responses in patients with relapsed and refractory cancers.”

Dr. Moser acknowledged the essential role of the Scottsdale Shea Medical Center inpatient and research pharmacy teams, as well as the Cancer Transplant Institute for their support and partnership in building the TILs program.