Tumor Infiltrating Lymphocytes TIL Therapy Clinical Trials Market Size Companies Insight

Release Date: 27-Mar-2023

The use of the body’s immune system to fight diseases like cancer has emerged as a promising strategy, which is being wholly exploited by researchers and drug makers, especially since the advent of targeted therapy. Another new entrant to this market is adoptive therapy with tumor-infiltrating lymphocytes, which is being assessed in many solid tumors. Though no tumor-infiltrating lymphocyte therapy has been approved by any drug regulatory body till now, the slow advancement of candidates to late stage trials promises a bright future for both tumor-infiltrating lymphocyte therapy and cancer patients who have been resistant or refractory to other therapies.


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At present, Lifileucel is the only tumor-infiltrating lymphocyte therapy candidate present in late clinical trial phases. Iovance Biotherapeutics developed Lifileucel, which is an autologous cell therapy that has entered pivotal phase III studies for the treatment of melanoma after treatment with anti-PD-1 therapy. It has been accorded the Regenerative Medicine Advanced Therapy Designation by the US FDA for this indication, which is a designation given to therapies with the potential to meet unmet medical needs for a disease or condition based on preclinical clinical data. The FDA has given it the classification of "breakthrough therapy" in recognition of this. Lifileucel is now undergoing evaluation for treating melanoma and cervical cancer patients who have had chemotherapy and anti-PD-1 therapy.

Another promising tumor-infiltrating lymphocytes therapy candidate is ITIL-168, developed by Instil Bio. This asset was created using the company’s CoStAR platform, which enables the development of unique tumor-infiltrating lymphocytes that have undergone genetic engineering for therapeutic purposes. The FDA has given ITIL-168 the orphan drug designation for the management of melanoma, which puts light on its potential. As a result of the numerous recent studies that have shown the effectiveness of tumor-infiltrating lymphocyte therapy in the treatment of melanoma, this disease has been a common indication for several of these therapies. Nonetheless, tumor-infiltrating lymphocyte treatment has had success in treating melanoma, which is promoting further advancement for this indication.

The market for conducting clinical trials of newly developed tumor-infiltrating lymphocyte therapies for various cancers is currently dominated by smaller biotechnology companies, medical universities, and associated hospitals, despite the fact that none of the prominent global pharmaceutical companies have yet announced their entry into the market. Several organizations are studying various tumor-infiltrating lymphocyte therapies, majorly in the early stages of clinical trials, including Cellular Biomedicine Group, Grit Biotechnology, Intima Bioscience, Hebei Senlang Biotechnology, Memorial Sloan Kettering Cancer Center, Shanghai Juncell Therapeutics and Fudan University.


currently US is the leading the global clinical trials and the development of tumor-infiltrating lymphocyte treatments, followed by China, countries in the European Union and the UK. By offering incentives and reducing costs involved in the approval procedures, their drug regulatory agencies have also played a significant role in assuring the development of innovative therapies like the tumor-infiltrating lymphocyte therapy at a lesser cost. The FDA orphan drug designation, which has been granted to some candidates in the clinical pipeline, is one that companies have been aiming for and Iovance has been able to achieve this for both its tumor-infiltrating lymphocyte therapies, which can potentially allow them market exclusivity in the US.

Particularly, tumor-infiltrating lymphocyte therapy has become recognized as a possible alternative for these treatments. They still have some limitations, though. The primary barrier to TIL therapy remains the tumor's immunosuppressive microenvironment.  As a method to overcome this, TILT Therapeutics is conducting clinical trials to assess the combination with tumor-infiltrating lymphocyte therapy in combination with its asset, TILT 123, an oncolytic virus. The combination works by trafficking tumor-infiltrating lymphocytes to the tumor site in response to the immunostimulatory signals generated by the oncolytic virus, leading to tumor destruction. This clinical trial is in phase I stage for metastatic melanoma and is expected to conclude in 2024, which may give an insight into the breakthrough combination.


Cell therapies have a great deal of potential for treating patients who did not significantly benefit from conventional medical treatments. Nevertheless, there is still a lot of potential for advancement in the identification and growth of efficient tumor-reactive T cells, as well as the investigation of alternate combined therapy. If efforts are made to create and improve them, tumor-infiltrating lymphocyte therapy is predicted to become one of the most popular cell therapies in the near future, potentially surpassing T cell-based therapies for the setbacks associated with them.

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