Oncolytics Biotech Inc. has announced that the first patients have been treated in a Phase 1b study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN® (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma (REO 024).
"Checkpoint inhibitors are an emerging class of therapeutic that allows the immune system to better recognize and target tumors, and the goal of this study is to assess their potential in combination with REOLYSIN®," said Dr, Brad Thompson, President and CEO of Oncolytics. "Based on our early research it is possible that checkpoint inhibitors could support improved survival outcomes for patients treated with oncolytic viral therapy."
The study is enrolling patients 18 years or older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first line treatment. It is an open-label Phase Ib trial designed to determine the safety and dose-limiting toxicities of REOLYSIN® and chemotherapy (gemcitabine or irinotecan or fluorouracil, at the treating physician's preference) in combination with pembrolizumab.
Secondary endpoints include overall response rate and progression free survival by immune-related response criteria; overall survival; and effects of REOLYSIN® and pembrolizumab when administered in combination as determined by analysis of pre- and post-treatment treatment biopsies and blood-based immune markers. Following an initial six to nine patient safety run-in, up to an additional 15 patients may be enrolled for further evaluation of safety and efficacy.