Tumour Infiltrating Lymphocyte (TIL) Adoptive Cell Transfer (ACT) is a robust treatment for patients with metastatic melanoma resistant to standard immune checkpoint inhibitors (ICI) such as pembrolizumab (anti-PD1). TIL ACT involves surgical excision of tumour deposits, followed by ex-vivo expansion in specialised laboratories of high numbers of immune cells (up to 100 billion) which are infused into the patient to treat their melanoma. The M14 phase III trial compared TIL ACT to ipilimumab as second line treatment after anti-PD1 and cell therapy displayed a higher objective response rate of 49% compared to 21%. Moreover around 25% of patients treated with TIL ACT had durable responses at the 5 year landmark. Given more than 66% of patients develop resistant to ICI in the metastatic melanoma there is great need for TIL ACT in Australia.
Currently TIL ACT is only available in specialised facilities in the US and Europe. However the technical and infrastructure hurdles have been overcome with a partnership with Harry Perkins Institute of Medical Research and Cell and Tissue Therapies Western Australia (CTTWA) which is a Therapeutic Goods Administration (TGA) and Foundation for Accreditation of Cellular Therapy (FACT) Good Manufacturing Practice (GMP) approved cell manufacturing facility. The PERTIL trial will open in Q1 2025 for patients with ICI resistant metastatic melanoma and will establish TIL ACT as a locally manufactured cell therapy product to Australian patients.