Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that the first patient was treated in a phase 2 study combining pelareorep with Merck’s Keytruda® to treat advanced pancreatic adenocarcinoma. The primary objective of the study is to determine the overall response rate (ORR) by iRECIST criteria. Secondary objectives include safety of the combination, immune response as determined by analysis of pre- and post-treatment biopsies and blood-based immune markers, determination of progression-free survival (PFS) by iRECIST criteria; and one-year, two-year and median overall survival (OS).
“We are very excited to start enrollment in this combination study which expands upon our findings from an earlier Keytruda study in advanced pancreatic cancer,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. “REO 024, our previous phase 1b study with Keytruda, showed objective response, long-term stabilization of disease and promotion of an inflamed phenotype in second line pancreatic cancer patients. This new phase two study should corroborate anti-tumor activity and potentially confirm predictive biomarkers laying the groundwork towards our goal of becoming a standardized backbone for checkpoint inhibitors.”
This study is a phase 2, single arm, open-label study enrolling up to 30 patients with advanced pancreatic adenocarcinoma who experienced disease progression or did not tolerate first-line therapy. The principal investigator is Dr. Devalingham Mahalingam, of Northwestern University. The first 16 patients will be enrolled in stage one, and up to 14 additional patients will be enrolled in stage two if pre-specified criteria are met. The pre-defined criteria state that, for the primary objective, three or more responses out of 16 are needed in stage one to continue the trial to the full 30 patients.