- Patients with mutated p53 metastatic breast cancer saw a
statistically significant improvement in median overall survival
from 10.4 months in the control arm to 20.9 months in the test arm;
and
- A registration study in metastatic breast cancer, with a focus
on p53 mutations, is being designed with overall survival as the
primary endpoint.
CALGARY, April 5, 2017 /PRNewswire/ - Oncolytics
Biotech® Inc. (Oncolytics or the Company) (TSX:ONC)
(OTCQX:ONCYF) today announced data demonstrating a statistically
significant (p=0.03) overall survival (OS) benefit for patients
with mutated p53 metastatic breast cancer, when treated with
REOLYSIN®, an immuno-oncology viral
agent, in combination with paclitaxel. Results from
IND 213, an open-label, randomized, phase 2 study were presented at
the Annual Meeting of the American Association of Cancer Research
(AACR), April 1-5, 2017 in
Washington, D.C.
"Mutations of the p53 tumor suppressor gene play an increasingly
challenging role throughout the life cycle of cancer," said Dr.
Matt Coffey, President & Chief
Executive Officer of Oncolytics. "As breast cancer progresses
clinically, p53 mutations become more prominent and negatively
impact therapeutic efficacy and overall survival. These data
provide evidence that combining REOLYSIN with paclitaxel may
improve survival for this difficult-to-treat, well characterized,
patient population."
The open-label, randomized, phase 2 study enrolled 74 patients
with metastatic breast cancer, 82 percent (61 patients) of whom
presented with p53 mutated tumors. The results show patients with
mutated p53 metastatic breast cancer that were treated with
REOLYSIN in combination with paclitaxel (n=30) had
a median OS of 20.9 months versus 10.4 months (n=31) in patients
treated only with paclitaxel. The study was designed and
conducted by the Canadian Cancer Trials Group (CCTG, formerly known
as the National Cancer Institute of Canada - NCIC).
"The observed survival benefit is very exciting and reinforces
the effectiveness and tolerability of REOLYSIN in patients with
mutated p53 metastatic breast cancer, while demonstrating its
potential utility in earlier lines of treatment for this
difficult-to-treat, high-risk group of patients," said Dr.
Andres Gutierrez, Chief Medical
Officer of Oncolytics. "These data indicate overall survival is
more than doubled for patients when treatment with REOLYSIN is
added to the standard of care and highlight key considerations for
the design and execution of a registration study in breast cancer.
Our immediate next steps include seeking advice from key opinion
leaders and regulators on refining our go-forward regulatory
strategy and registration pathway."
In the abstract for the poster, the CCTG had previously reported
that in the intention-to-treat 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
threshold with powering of 90 percent. 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). With this overall
survival data and the additional data from the p53 patient group,
the company has commenced the planning of a registration study in
metastatic breast cancer with overall survival as the primary
endpoint.
The poster, 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)" will be available on the Oncolytics website at:
http://www.oncolyticsbiotech.com/for-investors/presentations.
About Breast Cancer
The National Cancer institute
reported 246,660 new cases of breast cancer diagnosed in
the United States and 40,450
deaths from the disease in 2016.
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.