After Dramatic Results, FDA Approves TIL Therapy for Rare, Aggressive Cancers

Physicians at Orlando Health are pioneering a breakthrough protocol using tumor-infiltrating lymphocytes (TIL) to address aggressive, late-stage melanoma and other advanced cancers refractory to upfront immune checkpoint inhibitors. The groundbreaking treatment received FDA approval in mid-February 2024. It is the result of an ongoing multi-center international clinical trial under the direction of principal investigator Sajeve Thomas, MD, a board-certified medical oncologist and hematologist with Orlando Health Cancer Institute.

Called autologous TIL therapy, this novel approach utilizes the patient’s own T-cells to combat the disease. “We isolate the cancer-specific T-cells from a resected tumor, expand and proliferate them, producing anywhere from one billion to 150 billion cells,” says Dr. Thomas, who specializes in the treatment of melanoma, sarcoma and gastrointestinal conditions. “We then infuse the T-cells back to the patient, combined with additional medications to re-energize these cytotoxic T-cells against the cancer. This is done in a single infusion during one hospital admission.”

When patients respond well to treatment, results can be dramatic, melting tumors in a matter of weeks with no further therapies. Clinical trials found tumors shrank or remained stable in four out of five patients, with significant results evident within 90 days of treatment. Tumors can continue to regress, becoming non-existent in some patients, who remain progression-free months and even years after the initial treatment. Based on this success, researchers at Orlando Health currently are overseeing trials expanding TIL therapy for frontline melanoma combined with checkpoint inhibitors, lung, cervical, and head/neck cancers. 

The treatment is presently awaiting approval from the U.S. Food and Drug Administration for metastatic melanoma refractory to immunotherapy and targeted therapy. “Orlando Health is one of only 2 or 3 locations in Florida to provide cellular therapy using TIL,” says Dr. Thomas.

Orlando Health Cancer Institute was named in the Becker's Hospital Review “60 Hospitals and Health Systems with Great Oncology Programs” 2023 list and is recognized nationally for its novel therapies and research to improve patient outcomes and access to care.