September 8, 2025 — Leads & Copy — Oncolytics Biotech Inc. highlighted clinical and translational data from three metastatic colorectal cancer (mCRC) studies demonstrating efficacy, immune activation, and survival outcomes exceeding historical benchmarks.
In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab achieved a median progression-free survival (PFS) of 16.6 months versus 5.7 months with the standard regimen in platinum refractory 2L mCRC KRAS mutant patients. The median overall survival (OS) was 27.0 months versus 11.2 months with the standard regimen.
In the GOBLET study’s 3L mCRC Cohort 3, pelareorep combined with atezolizumab and TAS-102 met its predefined efficacy endpoint, achieving durable disease control and survival rates greater than historical benchmarks for 3L mCRC treated with TAS-102.
The REO 022 trial and the REO 013 translational study demonstrated viral replication and immune activation in tumors from mCRC patients. These findings confirm pelareorep’s mechanism of action, including its ability to modify mCRC tumors to be immune responsive and amenable to checkpoint inhibition.
The company plans to define a regulatory pathway and advance a potential investigator-sponsored trial (IST) in the KRAS mutant CRC patient population. “These studies validate pelareorep’s mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients,” said Jared Kelly, CEO of Oncolytics.
Dr. Sanjay Goel, professor and attending physician at Rutgers University, added, “We plan to initiate an investigator-sponsored trial to further explore pelareorep’s promising potential in KRAS mutant mCRC, building on the robust immune activation demonstrated in REO 013 and the survival benefit seen in REO 022.”
Contact:
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com
Source: Oncolytics Biotech® Inc.
