First drug in TILs on the horizon!
Tumor infiltrating lymphocytes(TILs) cell therapy will see the transfomation from benchside to bedside after ~30 years of dedicated academic and industrial efforts!
1. Why TILs cell therapy has a high likelihood of getting a nod from FDA?
In this field, Iovance and the Netherlands Cancer Research are at the forefront of TILs development, both with a primary focus on advanced melanoma—a substantial market characterized by unmet clinical needs. Iovance's clinical trial results, featured in JCO, along with the Netherlands Cancer Institute's clinical research, published in NEJM, underscore the significant potential of TILs in addressing this indication. Notably, participants underwent TILs therapy as a third-line (3L) treatment, yielding a promising response rate. The publication of these positive clinical outcomes in two prestigious clinical journals has heightened expectations in the field. In short, clinical data that is both transparent and robust has the power to captivate not only the academic community but also gain approval in regulatory processes.
2.The advantage of TILs therapy
TILs can offer a complementary approach to CART and immune checkpoint inhibitors (e.g., PD-1, CTLA-4). PD-1 or CTLA-4 therapies encounter resistance issues, affecting 40% to 65% of patients with advanced melanoma exhibiting primary resistance. CARTs are genetically modified T cells targeting specific cancer antigens, while TILs are recruited T cells within the cancer microenvironment. TILs possess inherent and diverse specificity towards cancer. CARTs currently face challenges in treating solid tumors, with the FDA warning of secondary cancer risks from CART treatments. In contrast, current TILs undergo no genetic modification, minimizing the risk of carcinogenesis. As TILs demonstrate success in melanoma treatment, a paradigmatic solid tumor, Iovance is also exploring their development in non-small cell lung cancer (NSCLC) and other solid tumors.If positive clinical outcomes emerge for these prevalent solid tumor types as well, TILs are positioned to outshine CART in the treatment of solid tumor. FYI, solid tumours still account for around 90% of all cancer deaths.
References:
1.Sarnaik, A. A. et al. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. JCO 39, 2656–2666 (2021).
2.Tumour-infiltrating lymphocyte cancer therapy nears FDA finish line
3.Rohaan, M. W. et al. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma. N Engl J Med387, 2113–2125 (2022).
1.Sarnaik, A. A. et al. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. JCO 39, 2656–2666 (2021).
2.Tumour-infiltrating lymphocyte cancer therapy nears FDA finish line
3.Rohaan, M. W. et al. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma. N Engl J Med387, 2113–2125 (2022).
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Joy Boy Myth : nice insight