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Oncolytics Biotech Inc. (ONC.T) has presented positive overall survival data from an open-label, randomized, phase 2 study designed by the Canadian Cancer Trials Group (CCTG) (formerly known as the National Cancer Institute of Canada). The 74-patient study, powered to 90 per cent, assesses the therapeutic combination of intravenously administered Reolysin given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer. Data from the study (investigational new drug 213) will be presented during the American Academy of Cancer Research (AACR) annual meeting from April 1 to April 5, in Washington, D.C.


  • Statistically significant improvement in median overall survival from 10.4 months in the control arm to 17.4 months in the test arm;
  • First time that an immuno-oncology viral agent has demonstrated a statistically significant median overall survival advantage in a randomized clinical study;
  • A registration study is now being designed in metastatic breast cancer with overall survival as the primary end point.

The abstract reports that, in the intention-to-treat patient population, there was an improvement in median overall survival (secondary end point) from 10.4 months on the control arm to 17.4 months on the test arm (hazard ratio 0.65, 80-per-cent confident interval of 0.46 to 0.91, p-value of 0.1), meeting the prespecified significance level for the 90-per-cent-powered study. Consistent with Reolysin acting as an immune therapy agent, there was no meaningful improvement in either progression-free survival (the primary end point) or response rate (secondary end point). The company is now planning a registration study in metastatic breast cancer with overall survival as the primary end point.

"This is the first controlled, randomized study where the systemic administration of an immuno-oncology viral agent (Reolysin) was well tolerated and had a significant impact on the overall survival of relapsed metastatic breast cancer patients when used in combination with paclitaxel," said Dr. Karen Gelmon, head of the investigational drug program, experimental therapeutics, department of medical oncology, B.C. Cancer Agency.

"There is an emerging pattern, from this and other studies with Reolysin, where patients obtain significant benefit in overall survival, despite limited impact on response rates and/or progression-free survival," said Dr. Andres Gutierrez, chief medical officer of Oncolytics. "This is a well-established pattern for other immunotherapies, like checkpoint inhibitors, which have been approved on an overall survival primary end point in melanoma, [non-small-cell lung cancer], and head and neck cancers. These phase 2 data also support the established mode of activity of Reolysin where selective cell lysis of permissive cancer cells is followed by an anti-tumour immune response, which may be responsible for the meaningful survival benefit for patients. Taking into account the specific findings from this study, we continue to believe that Reolysin is not solely an oncolytic agent but has key attributes of an immuno-oncology agent as well."

The abstract, authored by Bernstein et al., "A randomized (RCT) phase II study of oncolytic reovirus (pelareorep) plus standard weekly paclitaxel (P) as therapy for metastatic breast cancer (mBC)," is now available on the AACR website. CCTG will be making a poster presentation, No. 8466, at the AACR annual meeting, on Tuesday, April 4, 2017, from 1 p.m. to 5 p.m. in Washington, D.C.

Oncolytics would like to thank the patients that participated in this study, the CCTG, and all the physicians and nurses involved.

About breast cancer

The American Cancer Society estimates there will be 255,180 new cases of breast cancer diagnosed in the United States and 41,070 deaths from the disease in 2017.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing Reolysin, an immuno-oncology viral agent, as a potential treatment for a variety of tumour types. The compound induces selective tumour lysis and promotes an inflamed tumour phenotype through innate and adaptive immune responses to treat a variety of cancers. Oncolytics's clinical development program emphasizes three pillars: chemotherapy combinations to trigger selective tumour lysis, immunotherapy combinations to produce adaptive immune responses and immune modulator (IMiD) combinations to facilitate innate immune responses. Oncolytics is currently planning its first registration study in breast cancer as well as studies in combination with checkpoint inhibitors and IMID/targeted therapies in solid and hematological malignancies.