On December 3, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that the Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study following their review of initial safety data. Enrollment in this cohort will resume pending final approval from the Paul Ehrlich Institute (PEI), Germany’s medical regulatory body (Press release, Oncolytics Biotech, DEC 3, 2024, View Source [SID1234648756]). Additional updates are expected in 2025, with safety data anticipated in the first half and initial efficacy results in the second half.

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The GOBLET study is a Phase 1/2 randomized, open-label, multicenter trial using a Simon two-stage design to evaluate treatments across multiple gastrointestinal cancers. In cohort 5, the study is assessing pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab (Tecentriq), in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). This cohort is funded by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to speed up the development of new pancreatic cancer treatments.

"We see a promising opportunity for pelareorep to improve treatment options for PDAC patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The current standard of care is primarily chemotherapy, such as gemcitabine + nab-paclitaxel or mFOLFIRINOX. Pelareorep has already shown synergy with gemcitabine, nab-paclitaxel, and atezolizumab in GOBLET Cohort 1, and demonstrating efficacy with mFOLFIRINOX would further establish its potential to benefit PDAC patients. This study also builds on Cohort 1 by evaluating pelareorep’s ability to work with checkpoint inhibitors, which would be a major advance, especially as immune therapies provide little benefit in most patients with this ‘cold’ tumor."

About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate 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.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.