Oncolytics Biotech's Pelareorep Shows Potential in Extending Survival for Metastatic Breast Cancer Patients

One in eight women will face a breast cancer diagnosis in the U.S., with one in three becoming metastatic. This form of cancer often spreads to the bones, lungs, or liver and frequently develops resistance to endocrine-blocking therapies, leading to recurrence in approximately 50% of patients. The five-year survival rate for distant metastatic breast cancer is 29%.

The metastatic breast cancer treatment market is expected to grow at a CAGR of 10.4% from 2021 to 2030, reaching $41.74 billion. Oncolytics Biotech Inc. (NASDAQ: ONCY) is among the companies aiming to control cancer and increase survival rates. Their leading agent, pelareorep, has shown promising results in Phase 1 and 2 studies.

Pelareorep, an intravenously delivered immunotherapeutic agent, induces anti-cancer immune responses and promotes an inflamed tumor phenotype, turning “cold” tumors “hot.” It works by generating, recruiting, and training immune cells to recognize and kill cancer cells while remodeling the tumor microenvironment to enable immune cell access. When combined with existing treatments like chemotherapy, pelareorep has demonstrated the potential to extend survival times and expand T cell clones in the blood.

In Oncolytics' randomized Phase 2 trials, known as BRACELET-1, pelareorep showed meaningful improvements in overall response rate and progression-free survival. A previous trial also indicated a statistically significant near doubling of median overall survival.

Pelareorep has consistently expanded T cell clones and increased CelTIL scores and tumor-infiltrating lymphocyte counts, while maintaining a manageable safety profile. Positive data from BRACELET-1 and IND-213 trials showed significant clinical improvements in the pelareorep/paclitaxel combination arms compared to paclitaxel monotherapy. Multiple patients in the pelareorep/paclitaxel arm continue to be followed for survival, with results expected in the second half of the year.

Pelareorep has fast track designation from the FDA, facilitating expedited review for serious conditions needing novel treatments. Oncolytics recently had a productive Type C meeting with the FDA to support the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer. The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint.

“Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics.

Oncolytics’ mission is to make pelareorep available to breast cancer patients in need of better treatment options. With clinical trials demonstrating pelareorep’s potential and a significant new trial in the works, the company may indeed have a promising treatment on their hands.