NewLink Genetics has launched Phase 3 algenpantucel-L immunotherapy study in patients with borderline resectable or locally advanced unresectable pancreatic cancer.
The algenpantucel-L immunotherapy product candidate consists of a group of two allogeneic pancreatic cancer tumour cell lines that were modified to express Alpha-Gal.
The open-label, multi-institutional study will enrol and randomise 280 subjects and patients (1:1) with standard of care Folfirinox plus or minus algenpantucel-L (HyperAcute-Pancreas) immunotherapy.
NewLink chief executive officer Dr. Charles Link said the company is initiating an additional Phase 3 trial for algenpantucel-L to potentially expand into a new indication for locally advanced pancreatic cancer.
"The successful expansion of algenpantucel-L into a market segment for locally advanced disease would potentially more than double the patient population who might benefit from this immunotherapy treatment," Dr. Link added.
The evaluation of the overall survival is the primary endpoint while the secondary objectives include evaluation of progression free survival and immunological response.