Oncolytics: first patient treated in Phase 2 Pelareorep, Keytruda study

Oncolytics Biotech (ONCY) announced that the first patient was treated in a phase 2 study combining pelareorep with Merck’s (MRK) Keytruda to treat advanced pancreatic adenocarcinoma. The primary objective of the study is to determine the overall response rate 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 by iRECIST criteria; and one-year, two-year and median overall survival. 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.
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