US-based biotechnology firm Iovance Biotherapeutics has commenced patient dosing in its Phase II C-145-04 clinical trial of LN-145 to treat recurrent, metastatic or persistent cervical carcinoma.
LN-145 is an adoptive cell transfer (ACT) therapy that uses tumour-infiltrating lymphocyte (TIL) technology originally developed by the National Cancer Institute (NCI).
In addition to cervical cancer, LN-145 is being assessed for metastatic melanoma, recurrent and / or metastatic squamous cell carcinoma of the head and neck.
The multicentre, single-arm, open-label interventional Phase II trial is designed to evaluate the safety and efficacy of the investigational agent in approximately 47 subjects.
During the trial, patients will be administered with a non-myeloablative (NMA) lymphocyte depleting preparative regimen and a subsequent autologous TIL infusion, followed by IL-2 regimen of up to six doses.
Iovance Biotherapeutics CEO Dr Maria Fardis said: “We initiated this study based on encouraging data generated by the NCI showing responses in three of the nine cervical cancer patients treated with TIL therapy.
“The C-145-04 trial will investigate the effect of Iovance’s TIL therapy in cervical cancer patients. We look forward to progress the study with the intent to report some initial data in 2018.”
In the NCI study, patients were given standard-of-care treatment such as previous chemotherapy or chemoradiotherapy, and two out of the total subjects demonstrated complete response at 46 months, as well as at 54 months follow up.
Expected to be completed in December 2023, the C-145-04 trial will measure the objective response rate as the primary outcome.
The trial’s secondary measures include overall survival, complete response rate, duration of response, progression-free survival, disease control rate and incidence of treatment-emergent adverse events.
Image: Histopathology of cervical cancer. Photo: courtesy of Ed Uthman.