TIL Therapy Clinical Trials Cost Companies Market Size Insight

Release Date: 03-Apr-2023

Tumor-infiltrating lymphocyte therapy has been gaining popularity in the last few years thanks to the regulatory milestones achieved by some candidates currently in development or under clinical evaluation. With adoptive cell therapies now getting more popular as an alternative to the standard treatment procedures, tumor-infiltrating lymphocyte therapy is expected to find success while riding on the same wave. Different tumor-infiltrating lymphocyte therapies are now being evaluated for various solid cancers, but melanoma has been the most popular among these finding backing from the numerous studies done with the anti-cancer effects of lymphocytes in melanoma in the previous years. The first tumor-infiltrating lymphocyte therapy is expected to get approval in the next two years, providing hope for this emerging cancer therapy.


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The most popular tumor-infiltrating lymphocyte therapy in the pipeline is currently Lifileucel. The candidate developed by Iovance Biotherapeutics is also the closest to getting the FDA approval. The company filed a Biologics License Application (BLA) for Lifileucel to be used for the treatment of unresectable or metastatic melanoma in 2022; however, it was delayed by the FDA citing insufficient data. Iovance has since then conducted more clinical trials and has announced plans to file the BLA application again in 2023. Lifileucel is being evaluated in a phase III clinical trial, and apart from melanoma, it is also being evaluated in clinical trials with participants with cervical cancer. These trials are being conducted with using Lifileucel as both a monotherapy or in combination with other anti-cancer agents.


Other than Lifileucel, Iovance has another tumor-infiltrating lymphocyte therapy asset named LN-145, which is being evaluated in patients with head and neck squamous cell carcinoma (HNCCC) and non-small cell lung cancer (NSCLC). As an autologous adoptive cell therapy, LN-145 is being evaluated for in combination with Pembrolizumab, Ipilimumab and Nivolumab each, in different clinical trials, which is expected to result in the discovery of the most optimum combination of tumor-infiltrating lymphocyte therapy and immune checkpoint inhibitor. Along with LN-145, Lifileucel also has the orphan drug designation from the US FDA, which further solidifies its position as a competent candidate in the global pipeline.


Newer tumor-infiltrating lymphocyte therapies are being developed as autologous therapies, which is the need of the hour considering the unmet medical requirement of novel therapies for the treatment of cancer globally. Their availability as an off-the-shelf therapy guarantees commercial success in the long run, which is a deciding factor for the development of tumor-infiltrating lymphocyte therapies. This has been evidenced by the incrementing success of CAR-T therapies and also the increasing interest in NK cell therapy.


As a result of the recent surge in the development of tumor-infiltrating lymphocyte therapies, many candidates have been developed and lately, many of these have been entering the clinical trials after getting approvals from different regulatory bodies. For instance, Phio Pharmaceuticals and AgonOx announced the regulatory clearance for a clinical trials to evaluate the combination of their respective assets in January 2023. Phio’s PH-762 and AgonOx’s AGX148 are both tumor-infiltrating lymphocyte therapies developed using the companies’ respective platforms and technologies, and the new clinical was initiated soon after to assess the combination in melanoma and other advanced solid tumors. In February, Phio also announced that the Data Monitoring Committee (DMC) announced a positive review for PH-762 in a separate phase Ib trial, highlighting the potential of the candidate.      


Tumor-infiltrating lymphocyte therapies have shown a lot of potential to be used as monotherapies because of their mode of action. However, researchers are still eager to find ways to increase the efficacy and efficiency. Therefore, similar to other cancer therapies, investigators are now shifting their focus towards evaluating the combination of tumor-infiltrating lymphocyte therapies with other anti-cancer agents, majorly immune checkpoint inhibitors and chemotherapy drugs, and promising are expected in the years to come.


As an emerging therapy, tumor-infiltrating lymphocyte therapies have already demonstrated their potential in research and preclinical trials owing to which the current developments and expansion of the pipelines have been made possible. However, with the development of newer technologies, more breakthroughs are expected in the near future, which will propel the market for this novel therapy. The approval of Lifileucel, which is the closest to getting regulatory approval, is anticipated to cause a commotion in the market, which will allow for the entry of more candidates in the pipeline. Moreover, with the pharmaceutical industry now increasing focus on cellular therapies, it is highly likely that prominent drug makers will now want to venture into the market, increasing possibilities of partnerships and collaborations, giving a further boost to the development of tumor-infiltrating lymphocyte therapies.

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