Oncolytics Biotech announced on October 20, 2026, that it will present a REO 033 trial-in-progress abstract and e-poster at the European Society for Medical Oncology Congress 2026. The presentation concerns the design and ongoing development of its colorectal cancer study, not newly reported efficacy results.
Key Takeaways
- The randomized study tests whether adding pelareorep improves on a standard second-line colorectal cancer regimen.
- The trial plans to enroll 30 patients per treatment arm, with objective response rate as its primary endpoint.
- A potential pivotal expansion could support future approval applications, but that pathway remains conditional.
Table of Contents
- REO 033 tests pelareorep against standard treatment
- Earlier signals still need controlled confirmation
- Potential expansion is not an approval decision
- Conclusion
REO 033 tests pelareorep against standard treatment
Oncolytics’ REO 033 trial-in-progress announcement describes a randomized, controlled, open-label Phase 2 study in patients with RAS-mutant, microsatellite-stable metastatic colorectal cancer whose disease has progressed after first-line oxaliplatin-based therapy.
One group will receive pelareorep alongside FOLFIRI and bevacizumab. The comparison group will receive FOLFIRI and bevacizumab alone. FOLFIRI combines folinic acid, fluorouracil and irinotecan.
Pelareorep is an investigational immunotherapy being developed by Oncolytics, which trades on Nasdaq under the symbol ONCY. The trial’s direct comparison is intended to establish whether adding the drug improves outcomes beyond the existing treatment regimen.
| Item | Details |
|---|---|
| Conference | ESMO Congress 2026 |
| Presentation format | Trial-in-progress e-poster |
| Presentation number | 994eTiP |
| Planned allocation | 30 patients per treatment arm |
| Biomarker work | Blood and tumor samples are being collected for evaluation. |
Earlier signals still need controlled confirmation
The company said REO 033 is designed to validate encouraging findings from its earlier REO 022 study. Those findings involved second-line KRAS-mutant, microsatellite-stable colorectal cancer patients and comparisons with historical treatment outcomes.
Historical comparisons are not the same as results from patients randomly assigned within one study. REO 033’s randomized design therefore represents an important step in testing the earlier efficacy signals, rather than confirmation that those signals will be reproduced.
The primary endpoint is objective response rate, a measure of tumor response. Secondary assessments include overall survival, progression-free survival, disease control, response duration, and safety and tolerability.
Potential expansion is not an approval decision
Oncolytics said recent interactions with the U.S. Food and Drug Administration created an opportunity to initiate a pivotal expansion, called Part B, building on the currently enrolling Part A.
The company said that expansion could support an accelerated approval submission based on objective response rate and full approval based on progression-free survival. These are potential development routes, not completed submissions or regulatory approvals.
The announcement did not provide new REO 033 response or survival results, or a date for their release.
Conclusion
The next announced event is the ESMO trial-in-progress presentation. It will outline the ongoing study; evidence of pelareorep’s added benefit must come from subsequent controlled results.
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