- 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 endpoint.
CALGARY, March 31, 2017 /PRNewswire/ - Oncolytics
Biotech® Inc. (Oncolytics or the Company) (TSX:ONC)
(OTCQX:ONCYF) today announced the presentation of 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 - NCIC). The 74-patient study,
powered to 90 percent, 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 (IND 213), will be presented during the American Academy of
Cancer Research (AACR) Annual Meeting, April
1-5, in Washington, DC.
The abstract reports that in the intention-to-treat (ITT)
patient population there was an improvement in median OS (secondary
endpoint) from 10.4 months on the control arm to 17.4 months on the
test arm (Hazard ratio 0.65, 80% CI 0.46-0.91, p=0.1), meeting the
pre-specified significance level for the 90 percent powered study.
Consistent with REOLYSIN acting as an immune therapy agent, there
was no meaningful improvement in either progression free survival
(the primary endpoint), or response rate (secondary endpoint). The
Company is now planning a registration study in metastatic breast
cancer with overall survival as the primary endpoint.
"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,
Investigational Drug Program, Experimental Therapeutics, Department
of Medical Oncology, British Columbia 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
endpoint in melanoma, NSCLC 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-tumor 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, #8466, at the AACR Annual Meeting, on
Tuesday Apr 4, 2017 from 1:00 PM - 5:00 PM, in Washington, DC.
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 tumor types. The compound induces selective tumor lysis and
promotes an inflamed tumor phenotype through innate and adaptive
immune responses to treat a variety of cancers. Oncolytics'
clinical development program emphasizes three pillars: chemotherapy
combinations to trigger selective tumor lysis; immuno-therapy
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. For further
information about Oncolytics, please
visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements,
within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements, including the
Company's expectations related to the Phase 2 clinical trial in
breast cancer, future trials in this indication, and the Company's
belief as to the potential of REOLYSIN as a cancer therapeutic,
involve known and unknown risks and uncertainties, which could
cause the Company's actual results to differ materially from those
in the forward-looking statements. Such risks and uncertainties
include, among others, the availability of funds and resources to
pursue research and development projects, the efficacy of REOLYSIN
as a cancer treatment, the tolerability of REOLYSIN outside a
controlled test, the success and timely completion of clinical
studies and trials, the Company's ability to successfully
commercialize REOLYSIN, uncertainties related to the research,
development and manufacturing of pharmaceuticals, changes in
technology, general changes to the economic environment and
uncertainties related to the regulatory process. Investors should
consult the Company's quarterly and annual filings with the
Canadian and U.S. securities commissions for additional information
on risks and uncertainties relating to the forward-looking
statements. Investors should consider statements that include the
words "believes", "expects", "anticipates", "intends", "estimates",
"plans", "projects", "should", or other expressions that are
predictions of or indicate future events or trends, to be uncertain
and forward-looking. Investors are cautioned against placing undue
reliance on forward-looking statements. The Company does not
undertake to update these forward-looking statements, except as
required by applicable laws.
SOURCE Oncolytics Biotech Inc.