#United States #San Diego #Oncolytics Biotech #pelareorep #GOBLET Study

Oncolytics Biotech Advances Pancreatic Cancer Treatment

Oncolytics Biotech® Inc. has recently made significant progress in the fight against pancreatic cancer. The company announced important regulatory approval from Germany's Paul-Ehrlich-Institute (PEI), which will allow them to continue enrolling patients into Cohort 5 of the GOBLET study. This cohort focuses on evaluating the combined effects of pelareorep—a promising immunotherapeutic agent—and modified FOLFIRINOX (mFOLFIRINOX), both with and without atezolizumab (Tecentriq®), in patients newly diagnosed with pancreatic ductal adenocarcinoma (PDAC).

The approval follows a favorable safety evaluation conducted by an independent Data Safety Monitoring Board (DSMB), which recommended that the study continue. Early safety data from this study is slated for presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, with initial efficacy results anticipated later this year.

Dr. Thomas Heineman, Chief Medical Officer at Oncolytics Biotech, emphasized the potential of pelareorep to improve treatment outcomes for patients contending with metastatic pancreatic cancer. He remarked on the encouraging tumor response rates noted in previous cohorts of the GOBLET study, highlighting the therapy's promise for this challenging condition. This new cohort allows researchers to investigate an alternate chemotherapy regimen, mFOLFIRINOX, thereby extending the pool of pancreatic cancer patients who could potentially benefit from this innovative treatment.

Details of GOBLET Cohort 5

The mFOLFIRINOX group within the Phase 1/2 GOBLET study aims to treat newly diagnosed metastatic PDAC patients through a combination of pelareorep and mFOLFIRINOX with or without the addition of atezolizumab. The trial design includes an initial three-patient safety run-in phase to assess the safety and tolerability of each treatment variant, which will ultimately be evaluated over 30 patients across various treatment arms. Co-primary endpoints include both the objective response rate (ORR) and safety metrics.

Should the preliminary success criteria be met, the study could advance to Stage 2, enrolling a further 17 evaluable patients in one or both treatment arms. The collection of blood and tumor specimens will also support translational evaluations.

Background on the GOBLET Study

The GOBLET study, which stands for Gastrointestinal Tumors Exploring the Treatment Combinations with the Oncolytic Reovirus Pelareorep and Anti-PD-L1, is an ambitious phase 1/2 clinical trial evaluating various treatment combinations for advanced or metastatic gastrointestinal tumors across multiple sites in Germany. The study, managed by AIO-Studien-gGmbH, is designed to explore several cohorts involving pelareorep combined with approved cancer therapies.

About Oncolytics Biotech

Oncolytics Biotech is a clinical-stage biotechnology company recognized for its role in the development of pelareorep, an importante intravenous immunotherapeutic agent. This agent has shown considerable efficacy in randomized Phase 2 trials that have focused on metastatic cancers, showcasing its capability to induce immune responses against tumors. Currently, Oncolytics is actively involved in conducting and strategizing further combination clinical trials aimed at various solid malignancies, particularly in the realms of metastatic breast and pancreatic cancer. Both of these indications have received Fast Track designation from the FDA, paving the way for further advancements.

This recent regulatory milestone could herald a transformative change in treatment options for patients battling metastatic pancreatic cancer, a condition that currently faces a significant lack of effective therapeutic strategies. As research progresses in the GOBLET study, the medical community remains hopeful that pelareorep could represent a groundbreaking advancement in cancer treatment.