Oncolytics Reports Foothold In Chinese Pharmaceutical Market With Latest Breast Cancer Clinical Trials

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Oncolytics Biotech Inc. ONCY in January announced its partner in China — Adlai Nortye — has advanced the second dose level in a bridging clinical trial evaluating Oncolytics’ pelareorep in combination with paclitaxel therapy as a treatment for metastatic breast cancer. 

The news came after determination that the first dose level administered beginning in October showed no safety issues, and Oncolytics continues to complete parallel clinical trials of the same treatment in North America in collaboration with Pfizer Inc. PFE and Merck KGaA MKKGY. 

The bridging trial will allow Adlai Nortye to include data from the North American metastatic breast cancer trials of the same combination treatment in future submissions to the National Medical Products Administration (NMPA), China’s regulatory equivalent of the Food and Drug Administration (FDA). 

The first North American trial, referred to as IND-213, revealed a statistically significant improvement in overall survival for the group treated with the pelareorep-paclitaxel combination compared to the group treated with paclitaxel alone. 

A second phase 2 trial already underway is expected to add even more supportive data for the treatment as Oncolytics and Adlai Nortye work toward NMPA approval. The top-line data from that trial is expected by the end of this year. 

The Global Metastatic Breast Cancer Market

In 2020 alone, 2.3 million women worldwide were newly diagnosed with breast cancer, officially surpassing lung cancer to become the most commonly diagnosed cancer in the world. It’s also the leading cause of death for women in 110 countries. 

Of those 2.3 million new cases, China and the United States together accounted for 29%. 

According to a 2005 article in The Oncologist, about 30% of patients diagnosed will eventually develop metastatic breast cancer, the most advanced stage of the disease. Once cancer reaches this stage, the five-year survival rate drops from 90% for earlier-stage breast cancer to just 28%.

With disease rates expected to continue climbing, the global market for metastatic breast cancer therapeutics is projected to exceed $34 billion by 2027. 

As recent research shows that breast cancer can be made less immunologically cold (unlikely to trigger an immune response) with new drugs and immunotherapy treatments, an additional source of the market’s growth may come from adapting immunotherapies to treat breast cancers. A National Institute of Health study published this month, for example, showed that by stimulating an immune response with tumor-infiltrating lymphocytes, 67% of metastatic breast cancer patients in its clinical trial generated an immune response to their cancer.  

Oncolytics’s Pelareorep Enhances Existing Immunotherapy

With its focus on promising immunotherapies, Oncolytics is developing pelareorep, a nonpathogenic virus that can weaken tumor defense mechanisms while activating a patient’s immune system. 

In combination with a class of immunotherapies known as checkpoint inhibitors, like Roche’s Roche Holdings AG RHHBY atezolizumab, Pfizer’s PFE Bavencio® or Merck’s MRK Keytruda®, clinical studies have shown that pelareorep has the potential to generate an even more effective and longer-lasting cancer-fighting response.

Oncolytics has already presented clinical data in the HR+/HER2- breast cancer patient population that demonstrates synergies with checkpoint inhibitors, increases the number of tumor-infiltrating lymphocytes, and suggests success in future studies. With progress in both the bridging trial and the phase 2 trial in North America expected this year, Oncolytics is optimistic that it's getting closer to bringing the cancer therapy to market. 

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