The safety and efficacy of TIL cell therapy are under investigation and have not been established.
There are no guarantees that TIL cell therapies will receive US FDA approval for the uses being investigated.

Immunotherapy and
Cell Therapy

Cell therapies are a type of immunotherapy1

Several types of immunotherapies are used to treat cancer, and others are being investigated in clinical trials.
The principal types work as follows:

  • Immune checkpoint inhibitors block the immune system’s checkpoints that normally prevent T cells from attacking cancer cells.
    • Monoclonal antibodies help the immune system stay active to recognize and attack cancer by targeting specific sites on the surface of cancer cells and marking them for destruction
  • Therapeutic vaccines help increase the immune response by introducing cancer-specific antigens (not typically found on noncancerous cells) to the body.
  • Immune system modulators help enhance the immune response against cancer using natural immune-regulating agents such as interferons or interleukins.
  • Cell therapies are a novel approach to treating cancer: immune cells are collected from the patient, genetically modified (in some therapies), expanded in number, and given back to the patient, where they can attack cancer cells.

Some cell therapies are approved, while others are being investigated2,3

Different cell therapies are designed with different approaches in mind.

  • Thought to generate cancer-fighting cells by multiplying existing cells that are taken directly from the patient’s own tumor
  • Harnesses naturally occurring TIL, which are thought to recognize a multitude of patient-specific neoantigens
  • Currently being investigated as a treatment for solid tumor cancers

There are currently no FDA-approved TIL cell therapies. The safety and efficacy of TIL cell therapies are under investigation.

  • A patient’s T cells are engineered in a lab to include a chimeric antigen receptor (CAR) before being expanded and readministered
  • Designed to allow the T cells to attach to one specific antigen on the surface of cancer cells
  • Currently approved to treat hematologic cancers

To help address hurdles in cell therapy development in solid tumors, companies like Iovance are investigating TIL cell therapy.4

FDA=Food and Drug Administration; TIL=tumor infiltrating lymphocytes.

References: 1. National Cancer Institute, National Institutes of Health. Immunotherapy to treat cancer. Updated September 24, 2019. Accessed May 9, 2022. 2. Sarnaik AA, Hamid O, Khushalani NI, et al. Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma. J Clin Oncol. 2021;39(24):2656-2666. 3. Wolf B, Zimmermann S, Arber C, et al. Safety and tolerability of adoptive cell therapy in cancer. Drug Saf. 2019;42(2):315-334. 4. Wardell S, Lienlaf-Moreno M, Blaskovich M, et al. Iovance Gen 2 TIL manufacturing process produces drug products that exhibit favorable quality attributes for adoptive cell transfer across 5 solid tumor indications. Poster P226 presented at: SITC Annual Meeting; November 6-10, 2019; National Harbor, MD.

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Iovance Biotherapeutics 825 Industrial Road, Suite 400
San Carlos, CA 94070

Phone: 650-260-7120

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