Pelareorep shows prolonged survival benefit in KRAS mutant mCRC patients.

Oncolytics Biotech presented data from three mCRC studies showing pelareorep in combination with FOLFIRI and bevacizumab achieved prolonged survival benefits in KRAS mutant 2L mCRC patients, with median PFS and median OS approximately 2.5x the current standard of care. Translational data confirmed pelareorep replication in CRC tumors and immune activation. The company plans to define a regulatory pathway and advance potential IST in KRAS mutant CRC patient population.

Oncolytics Biotech Inc. (NASDAQ: ONCY) has presented compelling data from three metastatic colorectal cancer (mCRC) studies, demonstrating the efficacy of its immunotherapeutic agent, pelareorep, in combination with standard treatments. The company reported significant survival benefits in KRAS mutant 2L mCRC patients, with median progression-free survival (PFS) and median overall survival (OS) approximately 2.5 times the current standard of care.

In the REO 022 trial, pelareorep in combination with FOLFIRI and bevacizumab achieved a median PFS of 16.6 months and a median OS of 27.0 months, compared to 5.7 months and 11.2 months, respectively, with the standard 2L regimen [1]. The GOBLET study's 3L mCRC Cohort 3 also showed durable disease control and survival rates exceeding historical benchmarks for 3L mCRC treated with TAS-102.

Translational data from the REO 022 trial and the REO 013 study confirmed pelareorep's mechanism of action, including viral replication and immune activation, such as dendritic cell maturation and CD8+ T cell activation. These findings support pelareorep's ability to modify mCRC tumors to be immune responsive and amenable to checkpoint inhibition.

Oncolytics Biotech plans to define a regulatory pathway and advance potential investigational new drug (IND) status (IST) in the KRAS mutant CRC patient population. The company aims to establish an executable investigator-sponsored trial and work with leading investigators and regulators to design a confirmatory study leveraging data in the KRAS mutant patient setting.

The efficacy data for pelareorep in the hard-to-treat KRAS mutant population of mCRC are very encouraging. Dr. Sanjay Goel, professor and attending physician at Rutgers University, plans to initiate an investigator-sponsored trial to further explore pelareorep's potential in KRAS mutant mCRC, building on the robust immune activation demonstrated in REO 013 and the survival benefit seen in REO 022.

References:
[1] https://finance.yahoo.com/news/oncolytics-biotech-highlights-strong-efficacy-110000698.html