Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) announced that the Paul-Ehrlich-Institute (PEI) in Germany has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This regulatory decision allows the trial to proceed with evaluating pelareorep, an intravenously delivered immunotherapeutic agent, in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) for patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). The approval follows a positive safety review by the independent Data Safety Monitoring Board (DSMB).
GOBLET Study Design and Objectives
The GOBLET study (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) is a Phase 1/2 trial conducted across 17 centers in Germany and managed by AIO-Studien-gGmbH. Cohort 5 of the GOBLET study is specifically designed to assess the safety and efficacy of pelareorep in combination with mFOLFIRINOX, with or without atezolizumab, in patients with newly diagnosed metastatic PDAC. The study incorporates a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX.
In Stage 1, a total of fifteen evaluable patients will be randomized to each arm in this Simon two-stage study. The co-primary endpoints are objective response rate (ORR) and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.
Clinical Significance and Future Expectations
According to Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech, "Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer. Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed."
Early safety data from Cohort 5 is slated for presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, with initial efficacy results anticipated in the second half of the year. The advancement of pelareorep in this trial represents a step forward in exploring novel treatment combinations for pancreatic cancer, a disease with significant unmet medical needs.
