Therion Biologics has announced the results of its Phase III randomized, controlled clinical trial of PANVAC-VF for the treatment of patients with advanced pancreatic cancer. The trial did not meet its primary efficacy endpoint of improving overall survival compared with palliative chemotherapy or best supportive care, and the company no longer plans to file a biologics license application with the FDA.
The trial enrolled 255 patients with advanced pancreatic cancer. Based on the median overall survival of over six months in two Phase I studies, the Phase III study was powered to detect a two-month improvement over control chemotherapy.
In addition to advanced pancreatic cancer, PANVAC-VF is being investigated in studies sponsored by the National Cancer Institute for the treatment of advanced ovarian, colorectal and non-small cell lung cancers.