Oncolytics Biotech is partnering with other companies to develop immunotherapy and immunomodulatory applications for Reolysin, which improved breast cancer survival rates.
A combination of Reolysin and the chemotherapy Taxol (paclitaxel) increased the overall survival rate of patients with advanced or metastatic breast cancer by 67 percent, compared with Taxol alone, according to a Phase 2 clinical trial. The median survival rate of the breast cancer patients was 17.4 months with combo therapy, versus 10.4 months with Taxol by itself, the study showed.
Reolysin triggers cancer cell damage to prompt the immune system to recognize and attack cancer cells.
Results of the Phase 2 study were presented at the American Academy of Cancer Research (AACR) 2017 Annual Meeting in Washington. The presentation was titled “A randomized (RCT) phase II study of oncolytic reovirus (pelareorep) plus standard weekly paclitaxel (P) as therapy for metastatic breast cancer (mBC).”
The Phase 2 study compared the effectiveness of a combination of intravenous Reolysin and Taxol with Taxol alone in 74 patients with advanced or metastatic breast cancer. Median survival with the combo treatment was 17.4 months, versus 10.4 months for Taxol alone.
Sixty-one or 82 percent of the study participants carried mutated p53 tumors. The 30 patients with those mutations who were treated with the combination therapy had a median overall survival rate of 20.9 months. The 31 patients treated with chemotherapy alone had a survival rate of 10.4 months.
The company believes the results support the continued development of Reolysin as a possible treatment for metastatic breast cancer.
“We have developed a comprehensive clinical plan for Reolysin predicated on its mechanism of action, excellent safety profile with more than one thousand patients treated and the compelling overall survival data recently announced in metastatic breast cancer,” Matt Coffey, Oncolytics’ president and CEO, said in a news release. “The registration path in the near term will look at combinations of Reolysin and chemotherapy agents, beginning with metastatic breast cancer.
Oncolytics’ development plan includes trying Reolysin in combination with immunomodulatory drugs — treatments that help regulate the immune response.
“We intend to look at other pillars of the platform, and our long-range focus for Reolysin includes establishing collaborations with large pharma to study both immunotherapy and immunomodulatory drug combinations, such as the recently announced collaboration with Myeloma UK and Celgene using Revlimid and Imnovid in combination with Reolysin in myeloma patients,” he added.
The MUK eleven Phase 1b (NCT03015922) trial will investigate the safety and effectiveness of a combination of Reolysin and either Celgene’s Imnovid (pomalidomide) or Revlimid (lenalidomide) in patients with relapsing myeloma. The study will enroll about 44 patients at up to six Myeloma UK Clinical Trial Network centers.
Oncolytics is also investigating the effect of combining Reolysin with the immunotherapy agent Keytruda (pembrolizumab) and chemotherapy in patients with confirmed, advanced or metastatic pancreatic adenocarcinoma who failed to respond to standard therapy. Results from the REO 024 study (CT02620423) are expected in 2017.
“While our near-term focus will be on chemotherapy combinations, our longer-term goal is to establish Reolysin as the backbone of an immuno-oncology regimen in combination with other agents, including checkpoint inhibitors and other immunomodulatory drugs,” said Andres Gutierrez, Oncolytics’ CEO. “The combinations with emerging immunotherapies could be transformative when taking into account Reolysin’s continuing positive safety profile in ongoing studies.”
