Iovance Biotherapeutics has released updated results for its tumor-infiltrating lymphocyte (TIL) therapy, lifileucel, in melanoma patients. Data presented during the American Association of Cancer Research 2021 annual meeting in April revealed an overall response rate (ORR) of 36.4% in heavily pre-treated melanoma patients, with the median duration of response not met at 28.1 months of follow up.

Iovance is also investigating several other solid tumor indications, with ongoing trials for patients with cervical cancer, head and neck cancer, and non-small cell lung cancer. The company is expected to file for a Biologics License Application for refractory melanoma this year, which means lifileucel could be the first cell therapy approved for use in a solid tumor.

While CAR-T has revolutionized the way in which hematological malignancies such as acute lymphoblastic leukemia and B-cell lymphomas are treated, trials investigating cellular immunotherapies in patients with solid tumors have been less successful. The increased complexity of the tumor microenvironment can mean that access to the tumor site is limited and the environment may be more immunosuppressive.

The identification of targetable antigens for solid tumors has also been a problem. Use of TIL therapies can circumvent the need to identify targetable antigens. However, as TILs generated by the patient’s own immune system are isolated and expanded, they can target a whole range of different tumor-specific antigens. In this way, TIL therapy is distinctive from CAR-T therapy, as no gene editing is involved. One issue that could limit uptake of this type of personalized therapy is the necessarily complex manufacturing process. However, Iovance has managed to streamline this manufacturing process to only 22 days.

In addition to melanoma, Iovance has also reported impressive results in cervical cancer, with 44% ORR seen in heavily pre-treated patients, and promising early data from a small cohort of head and neck cancer patients. The head and neck cancer trial is investigating TIL therapy combined with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) in treatment-naïve patients, suggesting Iovance eventually hopes to bring this type of therapy into earlier treatment lines.

Most ongoing cell therapy trials are in early stages. Only 5% are in Phase II/III or Phase III, while 75% of trials are in Phase I or I/ll. Iovance’s data in melanoma and other solid tumors, particularly in patients who have failed multiple lines of prior therapy, suggest that cellular therapies may present viable options for patients with solid tumors. Iovance is set to be the leader in this space, with five ongoing Phase II trials. GlobalData anticipates US sales of lifileucel in refractory melanoma to reach $164M by 2029. If results remain positive, this type of TIL therapy could be transformative for patients with solid tumors, who would otherwise have limited therapeutic options.

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Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.

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