---
schema_version: "secwatch.filing_event.v1"
accession: "0001129928-26-000004"
form_type: "8-K"
ticker: "ONCY"
cik: "0001129928"
company_name: "ONCOLYTICS BIOTECH INC"
filed_at: "2026-02-04T23:59:59+00:00"
generated_at: "2026-05-16T04:48:59.763786+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Oncolytics gets FDA Fast Track for pelareorep in 2L KRAS-mutant MSS mCRC; interim data expected YE 2026

## Summary
- FDA Fast Track Designation for pelareorep + bevacizumab + FOLFIRI in second-line KRAS-mutant MSS metastatic colorectal cancer.
- Clinical data showed 33% ORR (vs ~10% SOC), 16.6-month PFS (vs 5.7 mo SOC), 27-month OS (vs 11.2 mo SOC).
- Company plans controlled study with first site activated March 2026; interim data expected by end of 2026.
- Estimated addressable market $3-5 billion annually for this difficult-to-treat population.

## SEC filing metadata
- accession: 0001129928-26-000004
- form_type: 8-K
- ticker: ONCY
- cik: 0001129928
- company_name: ONCOLYTICS BIOTECH INC
- filed_at: 2026-02-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1129928/000112992826000004/0001129928-26-000004-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1129928/000112992826000004/oncy-20260204.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001129928-26-000004
- JSON: https://secwatch.observer/filing/0001129928-26-000004.json
- Plain text: https://secwatch.observer/filing/0001129928-26-000004.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.