Oncolytics Biotech® Advances Pelareorep to Transform Cancer Treatments with Promising Survival Data

Oncolytics Biotech® Unveils Breakthrough Survival Data for Pelareorep

On July 8, 2025, Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a prominent player in the field of oncology-focused immunotherapy, announced crucial advancements pertaining to its leading treatment candidate, pelareorep. This intravenous oncolytic virus therapy has exhibited impressive clinical trial results across various tumor types, indicating a promising future in cancer treatment.

Commitment to Registration-Enabling Studies

During a strategic update, CEO Jared Kelly emphasized the company's shift towards robust data-driven decisions. He stated, "We are no longer in the business of funding proof-of-concept studies. We have meaningful clinical data in hand—not just signals." This decision follows impressive survival results indicating a noteworthy 21.9% two-year survival rate among patients treated for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), notably higher than the historical benchmark of 9.2%. Kelly's assertion reflects an intensified focus to propel pelareorep into registration-enabling trials, thereby expediting its journey into market availability.

Efficacy in Metastatic Pancreatic Cancer

The results stem from two pivotal trials investigating the efficacy of pelareorep when paired with a chemotherapy backbone. Out of more than 100 patients, the data reveals not only significant survival rates but also a striking 62% objective response rate (ORR) in a phase 2 clinical trial when combined with a checkpoint inhibitor. Currently, this treatment option stands out, as there are no FDA-approved immunotherapies viable for first-line treatment in mPDAC patients.

The clinical activity of pelareorep also extends into the HR+/HER2- metastatic breast cancer realm. Results from two randomized phase 2 trials indicated a remarkable median overall survival (mOS) benefit exceeding 10 months when compared with standard-of-care chemotherapy regimens. For instance, the IND.213 mOS was reported at 21 months against 10.8 months in the control arm, whereas the BRACELET-1 study hinted at even higher potential, with a conservative estimate indicating 32.1 months against 18.2 months.

Addressing Significant Unmet Needs

Dr. Thomas Heineman, Chief Medical Officer at Oncolytics, affirmed that pelareorep represents a potential game-changer, especially for 'cold tumors' unresponsive to traditional therapies. He remarked, "It is delivering consistent immunologic and clinical responses across various tumor types, thereby creating new opportunities for immune-based combination therapies."

The foundational safety profile of pelareorep is also reassuring. An expansive data pool encompassing over 1,100 patients indicates a favorable safety landscape for the treatment, with the majority of adverse events being relatively mild and manageable with common medications. Typically, patients experienced flu-like symptoms, including fever and fatigue.

Regulatory Pathways and Future Directions

Pelareorep has already received Fast Track designations from the U.S. FDA both in 2017 for metastatic breast cancer and again in 2022 for its use in combination with chemotherapy and atezolizumab for mPDAC. Furthermore, Oncolytics secured Orphan Drug Designations for pelareorep from both the FDA and the EMA for pancreatic cancer treatment.

As Oncolytics prepares for the next phases of clinical research, the anticipation grows within the oncology community. Their recently released corporate presentation provides in-depth clinical and translational data that will undoubtedly spark interest among stakeholders invested in the advancement of cancer therapies.

Conclusion

The recent announcements from Oncolytics Biotech signal a promising trajectory for pelareorep as a therapeutic agent against some of the most challenging cancers. With these pivotal data points in hand, the commitment to advancing pelareorep through regulatory pathways is set to reshape treatment landscapes for mPDAC and HR+/HER2- metastatic breast cancer. For more information, the company encourages interested parties to visit Oncolytics Biotech's website.