30 Apr 2021
Posted in Pharma
First cell therapy for solid tumors could be approved by 2022, says GlobalData
Although cell therapies such as CAR-T have been approved and used successfully to treat hematological cancers, there are currently no cell therapies approved for the treatment of solid tumors. However, positive data recently presented by Iovance Biotherapeutics from its lead candidate, tumor infiltrating lymphocyte (TIL) therapy lifileucel, in heavily pre-treated melanoma patients suggests an approval could be expected as early as next year. A total of 298 industry-sponsored trials are currently ongoing investigating cell therapies in non-hematological cancers, says GlobalData a leading data and analytics company.
Jessica McCormack, PhD, Oncology and Hematology Analyst at GlobalData, comments: “Iovance’s data in melanoma and other solid tumors, particularly in patients who have failed multiple lines of prior therapy, suggests that cellular therapies may yet present viable options for patients with solid tumors. There is currently no standard of care for melanoma patients who progress on immune checkpoint inhibitors, and if BRAF-positive, BRAF/MEK inhibitors. Should results remain positive, this type of TIL therapy could be transformative for this patient group, who would otherwise have very limited therapeutic options.”
Most ongoing cell therapy trials in non-hematological cancers are in the early stages; just 5% are in Phases III or II/III, while 74% of trials are in Phase I or I/II. These are also being sponsored by a large range of companies. Iovance looks set to be the leading figure in this space, with five ongoing Phase II trials, of which three are potentially registrational – more than any other company.
McCormack continues: “While CAR-T has revolutionized the way in which hematological malignancies, such as acute lymphoblastic leukemia and B-cell lymphomas are treated, solid tumors present different problems to liquid tumors. Solid tumors can be inaccessible to cell therapies, which must first exit the bloodstream to gain access to the tumor site and then potentially overcome dense extracellular matrix. The tumor microenvironment may also be immunosuppressive. Finally, the identification of targetable antigens for solid tumors has also been a problem.”
Iovance have been able to circumvent the issue of identifying effective tumor targets by utilizing TILs that are derived specifically from each patients’ tumor. These target a large range of tumor-specific antibodies and also means no additional genetic modifications are necessary, unlike with CAR-T.
McCormack concludes: “Melanoma is a relatively immunogenic cancer, which means that there is the potential for the isolation of multiple TILs with different specificities from the tumor sample. Iovance have also shown positive data in cervical cancer and head and neck cancer, and have ongoing trials of its LN-145 product in non-small cell lung cancer. This suggests that Iovance could bring its TIL therapies into a range of solid tumors in the future.”