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TIL therapy

When the first commercial tumor infiltrating lymphocyte (TIL) therapy was FDA approved for cutaneous melanoma in February 2024, researchers at Moffitt Cancer Center were already investigating the next generations of TIL for other solid tumor types.

Kedar Kirtane, MD, a medical oncologist in the  Head and Neck-Endocrine Oncology Department at Moffitt, is leading a phase 1b clinical trial to determine whether TIL therapy can be successful in treating patients with advanced head and neck squamous cell carcinoma (aHNSCC).

“Eighty percent of our patients on standard of care have disease progression, so it fails most of them,” Kirtane said. “This is a nice way to have a backup plan for those patients to make sure they can live longer and feel better.”

TIL therapy involves harvesting T cells found within a patient’s tumor, activating and expanding them in the lab and reinfusing those cells into the patient to seek out and destroy cancer. The cell manufacturing process takes on average between eight and 12 weeks.

Background of the trial was presented at the 2024 American Society of Clinical Oncology annual meeting.

The trial is enrolling patients between 18 to 75 years old with aHNSCC. Prior to receiving pembrolizumab with or without chemotherapy as first-line standard of care treatment, participants undergo surgery to harvest TILs from their tumor, followed by plasma removal to collect monocytes, a type of white blood cell that are part of the body's innate immune system.

Historically, cell therapies have relied on bulk products that may not effectively select a tumor-reactive T cell population. For this trial, Kirtane wanted to focus on being more selective of which TIL products are made to treat patients.

Kedar Kirtane, MD

Kedar Kirtane, MD

“One of the problems with the bulk TIL products is that some of those lymphocytes are not the best ones to recharge,” Kirtane said. “For this trial we wanted to determine which is the best lymphocyte to recharge and grow.”

After the tumors are harvested, patients are then given the standard of care treatment. If their disease progresses, the TIL product will be ready to give to the patient. If the patient’s disease does not progress, then the TIL product is put into storage.

“Right now, we don’t have a standard of care second-line treatment for this type of cancer,” Kirtane said. “There’s no, ‘What do we do next?’ There’s a lot of different trials out there, but my hope is that this tends to be a much more rational approach. What better place to find the cancer fighting machinery than in the cancer itself?”