Pelareorep is being studied across various gastrointestinal tumors, including pancreatic, breast, anal, and colorectal cancers, with some studies having Fast Track designation from the FDA.

Enrollment for Cohort 4 of the GOBLET trial has reached 20 evaluable patients and is expected to complete by the end of 2025, with efficacy results, focusing on ORR, anticipated in the fourth quarter of 2025.

An efficacy update for Cohort 4 is planned for the fourth quarter of 2025, and a subsequent interim efficacy update for Cohort 5, including overall survival data, is expected in the first quarter of 2026.

Oncolytics Biotech Inc. has reported progress on the GOBLET trial, which is evaluating pelareorep, an immunotherapeutic agent that activates immune responses, in gastrointestinal cancers, with early promising efficacy signals.

The company is expanding the GOBLET trial into the U.S., with Northwestern University leading the effort to include pancreatic cancer patients, addressing a significant unmet medical need.

A protocol amendment has been submitted to open U.S. sites for the GOBLET study, including Northwestern University, to bring the trial to U.S. pancreatic cancer patients.

Cohort 4's study of pelareorep combined with atezolizumab in anal canal squamous cell carcinoma has shown a 33% overall response rate in 12 patients, nearly tripling the response rate of retifanlimab in similar settings.

Enrollment for Cohort 4 is at 20 evaluable patients, with full enrollment expected by the end of 2025, and full results anticipated soon.

Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize the commercial impact of pelareorep, which has received Fast Track designation from the FDA for pancreatic and breast cancers.

The company aims to leverage clinical data to pursue regulatory approval and establish pelareorep as a platform immunotherapy for gastrointestinal tumors.

Oncolytics' CEO emphasized the importance of leveraging clinical data to clarify regulatory pathways and position pelareorep as a versatile platform immunotherapy for gastrointestinal cancers.

The U.S. expansion of the GOBLET trial is pending protocol approval, with Northwestern University and other academic institutions expected to serve as U.S. sites, aiming to address urgent needs in pancreatic cancer treatment.