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By Meg Flippin, Benzinga
One in eight women will face a breast cancer diagnosis in the U.S. Of those, one in three will become metastatic. When breast cancer metastases, it often spreads to the bones, lungs or liver. Unfortunately, these tumors eventually become resistant to endocrine-blocking therapies and can reoccur in approximately 50% of patients. Depending on how much and far the cancer spreads, the five-year survival for distant metastatic breast cancer rate is 29%.
The metastatic breast cancer treatment market is forecast to grow at a CAGR of 10.4% from 2021 to 2030, reaching $41.74 billion. With no direct cure in sight, keeping the cancer under control and increasing survival rates are the focus areas of biopharmaceutical companies, big and small, including Oncolytics Biotech Inc. (NASDAQ: ONCY).
The clinical-stage biopharmaceutical company specializing in immunotherapeutics for oncology and their leading agent pelareorep, has demonstrated promising results in Phase 1 and 2 studies to fight challenging cancers. When pelareorep was added to standard metastatic breast cancer treatment, overall survival rates nearly doubled in a randomized study of patients with HR+/HER2- breast cancer, reports Oncolytics.
Pelareorep is an intravenously delivered immunotherapeutic agent that induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot.” Pelareorep works by generating, recruiting and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access. When added to existing treatment regimens such as chemotherapy, pelareorep demonstrates the potential to extend survival times in addition to expanding existing and new T cell clones in the blood, the company reports.
Proving Its Mettle
In Oncolytics’ randomized Phase 2 trials, known as BRACELET-1, pelareorep demonstrated meaningful improvements in overall response rate and progression-free survival. Overall survival from this trial continues to mature. A previous randomized phase 2 trial also showed positive results, including a statistically significant near doubling of median overall survival observed.
Data from BRACELET-1 and AWARE-1 studies consistently show that pelareorep produces an expansion of T cell clones and/or an increase in CelTIL scores and peripheral tumor-infiltrating lymphocyte counts, reports the company. The trials also demonstrated a manageable safety profile which is consistent with prior studies.
Positive data from BRACELET-1 and IND-213 randomized trials showed meaningful clinical improvements in the pelareorep/paclitaxel combination arms compared to paclitaxel monotherapy, says Oncolytics. Multiple patients in the pelareorep/paclitaxel arm continue to be followed for survival, with overall survival results expected in the second half of the year.
“We believe this data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep,” said Wayne Pisano, interim CEO and chair of the board of Oncolytics. “We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients.”
Working Hand-In-Hand With The FDA
Pelareorep has fast track designation from the Food and Drug Administration, which allows for the expedited review of drugs for serious conditions that need novel treatments. Oncolytics was also recently part of a productive Type C meeting with the FDA to support the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC).
Oncolytics said the FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The company’s proposed study will enroll patients for whom hormonal therapy hasn’t worked and who have received no more than one line of antibody-drug conjugate (ADC) therapy.
“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.
“Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep’s immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options,” he said.
Breast cancer is common, and while many cases are treatable, metastatic breast cancer is a different story. At stage 4, the tumors have spread to other parts of the body and recurrence is frequent. Extending the survival rate is the name of the game, and Oncolytics thinks it has a winner with pelareorep. With clinical trials demonstrating pelareorep’s potential under its belt and a big one in the works, Oncolytics may be right.
Featured photo by Susan G. Komen 3-Day on Unsplash
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