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  • Letter to the Editor
  • Open access
  • Published:

Clinical trial landscape for TIL therapy: emerging insights and future directions in oncology

To the Editor,

Tumor-Infiltrating Lymphocytes (TIL) therapy is an innovative immunotherapeutic strategy, providing new prospects for difficult cancers [1]. Traditional cancer treatments such as surgery, chemotherapy, and radiation have limited effectiveness in late-stage cases and cause significant side effects [2]. TIL therapy, derived from in-depth research into the tumor microenvironment, involves extracting lymphocytes from a tumor, expanding them ex vivo, and reintroducing them to enhance the immune response against tumor cells [3]. This targeted approach not only aims to effectively destroy cancer cells but also reduces damage to normal cells, offering greater therapeutic potential with fewer side effects. The study evaluates the clinical trial prospects of TIL therapy and its transformative potential in cancer treatment.

In this study, we use the INFORMA database (https://pharma.id.informa.com/) to gather clinical trial data on Tumor-Infiltrating Lymphocytes (TIL), retrieving 268 trials via medical subject headings (MeSH) with the keyword ‘TIL.’ This dataset provides a comprehensive view of TIL therapy trials, detailing each trial’s phase, status, and targeted diseases. The data allows for a thorough evaluation of TIL’ applications and efficacy in cancer treatment, offering insights into emerging trends and identifying research gaps. This facilitates future studies and may influence oncology treatment protocols.

Through a detailed analysis of the INFORMA database, we have thoroughly explored the landscape of clinical trials concerning Tumor-Infiltrating Lymphocytes in cancer treatment, with our findings illustrated across four pivotal figures. Figure 1A delineates the distribution of trials across various phases, with a majority clustered in Phase 1 and Phase 2, indicating that TIL therapy is still in its nascent stages. Researchers are vigorously examining its safety profile and initial therapeutic efficacy. Figure 1B offers a snapshot of the trial statuses, including open, completed, or terminated studies, unveiling the vigorous progression and future potential of TIL clinical trials.

Fig. 1
figure 1

Comprehensive Overview of TIL Therapy in Clinical Trials. A Distribution of Trial Phases. B Status of Trials. C Distribution of Cancer Types in TIL Therapy Research. D Single and Combined Usage of TIL Therapy

Figure 1C highlights the top ten cancer types targeted by TIL therapy in clinical settings, showcasing its broad applicability across a diverse array of malignancies, particularly in critical areas such as melanoma, lung cancer, and renal cancer. This data accentuates the focused research on specific cancer types, underscoring the targeted nature and potential benefits of TIL therapy in these areas. Figure 1D delves deeper, analyzing the scenarios in which TIL therapy is employed either as a single treatment or in combination with other therapeutic strategies such as immunotherapy, chemotherapy, and targeted therapy. This analysis reveals a clear trend towards combination therapies, especially with immune checkpoint inhibitors and targeted treatments, highlighting the significant potential of TIL to enhance therapeutic outcomes and broaden its scope of application.

The analysis of these figures clarifies the use and research trends of TIL therapy, underscoring its potential in future cancer treatment. These detailed data analyses enhance our understanding of TIL’ role in oncology, offering a scientific basis and guidance for future research and clinical applications. This serves as a valuable resource for researchers and clinicians, supporting efforts to optimize and broaden the use of TIL therapy in combating cancer.

The findings of this study bear significant implications for the field of tumor immunotherapy. Notably, the pioneering approval of AMTAGVI (lifileucel) by the FDA in 2024, as the first TIL therapy for treating advanced melanoma, marks a major breakthrough in cellular and genetic therapy and heralds a new era of hope in tumor immunotherapy [4]. This milestone offers novel perspectives and profound insights for clinical medicine, pharmaceutical companies, and researchers, demonstrating the potential of advanced biotechnology to address tumor heterogeneity [5]. In recent years, China has made remarkable progress in the development of TIL therapy, particularly following the implementation of the “2024 Industrial Structure Adjustment Guidance Catalog.” Domestic TIL products such as GC203 and GT101 have exhibited outstanding clinical efficacy. GC203 achieved an 83.3% disease control rate in recurrent ovarian cancer, while GT101 reached a 90.9% rate across various solid tumors, significantly enhancing China’s global competitiveness in cell therapy. These advancements have paved new pathways for global cancer treatment.

Despite the innovative promise of TIL therapy, its widespread application faces challenges such as high costs, technical complexity, and potential side effects. Thus, future development must involve rigorous clinical trials to verify the broad efficacy and safety of these therapies. This approach not only confirms the clinical validity and feasibility of new treatments but also realizes their therapeutic potential across a broader patient cohort.

In conclusion, the evolution of TIL therapy represents not only a triumph of technological innovation but also reflects the support of medical policy and international collaboration. It opens new avenues for global cancer treatment, signaling the arrival of an innovative drug wave. We must embrace and promote these new treatments, ensuring they meet high scientific standards to genuinely benefit patients.

Abbreviations

TIL:

Tumor-Infiltrating Lymphocytes

FDA:

Food and Drug Administration

MeSH:

Medical Subject Headings

NMPA:

National Medical Products Administration

References

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Funding

This work was funded by the Shenyang Science and Technology Program for Public Health Research and Development (22-321-33-52) and the Wu Jieping Medical Foundation.

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Hujian Hong: Writing – original draft, Supervision, Methodology. Yijiang He: Conceptualization. Yan Li: Writing – review & editing. Yongyan Shen: Writing – original draft. Yanli Qu: Writing – review & editing, Visualization, Data curation.

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Correspondence to Yanli Qu.

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Hong, H., He, Y., Li, Y. et al. Clinical trial landscape for TIL therapy: emerging insights and future directions in oncology. J Transl Med 22, 1008 (2024). https://doi.org/10.1186/s12967-024-05826-z

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  • DOI: https://doi.org/10.1186/s12967-024-05826-z