Poster Presentation Australasian Melanoma Conference 2026

PERTIL-01: Australia’s First Phase II Trial of Locally Manufactured Tumour-Infiltrating Lymphocyte Therapy for Patients with Metastatic Melanoma Resistant to Immune Checkpoint Inhibitors  (#315)

Peter K Lau 1 2 3 , Lisa Nilsson 1 4 , Leon Brownrigg 3 , Kate Maslen 3 , Anna Reid 1 5 , Jessica Gornall 1 , Nima Mesbah Ardakani 6 , Lydia Warburton 2 7 , Robert Owen 8 , Alexandra O'Neill 8 , Dirck Ananos Flores 8 , Jason Waithman 9 , Elin Gray 1 5 , Jonas A Nilsson 1 4 , Benedict Carnley 3 10 , Zlatibor Velickovic 3
  1. Melanoma Discovery Laboratory, Harry Perkins Institute of Medical Research, Nedlands, WA, Australia
  2. Medical Oncology Department, Royal Perth Hospital, Perth, WA, Australia
  3. Cell and Tissue Therapies WA, Perth, WA, Australia
  4. Sahlgrenska Center for Cancer Research, University of Gothenburg, Gothenburg, Sweden
  5. Centre for Precision Health, Edith Cowan University, Joondalup, WA, Australia
  6. Anatomical Pathology, Pathwest Laboratory Medicine, Perth, WA, Australia
  7. Medical Oncology, Fiona Stanley Hospital, Murdoch, WA, Australia
  8. Plastic Surgery, Royal Perth Hospital, Perth, WA, 6009
  9. School of Biomedical Sciences, University of Australia, Nedlands, WA, Australia
  10. Haematology Department, Royal Perth Hospital, Perth, WA, Australia

 

Tumour Infiltrating Lymphocyte (TIL) therapy is an established autologous cell treatment, with Phase II and III trials demonstrating objective response rates of 30–50% and durable disease control in patients with metastatic melanoma resistant to conventional immune checkpoint inhibitors (ICI). The PERTIL-01 trial is a Phase II investigator-initiated study evaluating Perkileucel, a locally manufactured autologous TIL product for melanoma patients. Developed by the Harry Perkins Institute of Medical Research (HPI) in collaboration with Cell and Tissue Therapies WA (CTTWA) at Royal Perth Hospital (RPH), this is the first Australian trial to establish sovereign TIL manufacturing and delivery capability under Therapeutic Goods Administration (TGA) Good Manufacturing Practice (GMP) conditions.

Key inclusion criteria are adults between 18-70 years with unresectable or metastatic melanoma with prior progression to ICI treatment, ECOG performance status of 0–1, and a surgically accessible melanoma lesion ≥ 1.5 cm for TIL manufacture, RECIST measurable disease and adequate organ function. Patients with active brain metastases and uveal melanoma are excluded. Tumour tissue will be excised and undergo ex-vivo expansion at CTTWA. Patients will receive in-patient lymphodepletion chemotherapy with cyclophosphamide (60 mg/kg for 2 days) and fludarabine (25 mg/m2 for 5 days), followed by Perkileucel infusion and up to six doses of high-dose Interleukin-2 (600 000 IU/kg). Primary endpoint is objective response rate by RECIST 1.1, with secondary endpoints including progression free survival, overall survival, safety, translational correlates, and quality of life measures. 

Validation runs conducted from May 2024 to December 2025 have confirmed the feasibility and reproducibility of Perkileucel manufacture under GMP conditions. Manufacturing time of Perkileucel is approximately 4 weeks using an established 2 stage production process of young TIL followed by rapid expansion. PERTIL is scheduled to commence in mid 2026 with an initial cohort of 10 patients and a plan for 30 total participants. PERTIL-01 represents a landmark in Australian cell therapy, establishing an integrated clinical, translational, and manufacturing framework to deliver sustainable access for melanoma patients.