--Report More Than Doubling in One-Year Survival
and Nearly Five-Fold Increase in Two-Year Survival as Compared to
Historical Controls--
CALGARY, July 6, 2015 /PRNewswire/ - Oncolytics
Biotech® Inc. ("Oncolytics") (TSX:ONC)
(NASDAQ:ONCY) today announced that Dr. Devalingam Mahalingam of the
Cancer Therapy and Research Centre, University
of Texas Health Science Centre San Antonio, made a poster
presentation at the ESMO World Congress on Gastrointestinal Cancer.
The poster, titled "Oncolytic Virus Therapy in Pancreatic Cancer:
Clinical Efficacy and Pharmacodynamic Analysis of
REOLYSIN® in Combination with Gemcitabine in Patients
with Advanced Pancreatic Adenocarcinoma," covers final results from
the Company's REO 017 Phase 2 study.
"These data suggest that this drug combination can increase
median overall survival, as well as generate an approximate
two-fold increase in one-year survival rates, and a five-fold
increase in two-year survival rates when compared to gemcitabine
therapy alone as seen in historical data," said Dr. Matt Coffey, COO of Oncolytics. "The observation
of clear overall survival (OS) benefit combined with apparent
limited impact on progression free survival (PFS) is increasingly
becoming characteristic of immune-based therapeutic treatments. We
are incorporating this finding into both our new and existing
studies to ensure we follow OS where possible."
Highlights of the data presented include:
- A survival analysis for 33 patients showing a median
progression free survival (PFS) of four months and median overall
survival (OS) of 10.2 months;
- Data showing one- and two-year survival rates of 45% and 24%,
respectively; and
- An analysis demonstrating upregulation of immune checkpoint
marker PD-L1 in post treatment tumours suggesting the potential to
combine oncolytic viral therapy with anti-PD-L1 inhibitors in
future trials.
A summary of the overall data compared to historical controls is
shown below:
|
|
|
|
|
|
Treatment
|
Number of
patients
|
Median PFS
(months)
|
Median OS
(months)
|
1-year
survival
(%)
|
2-year
survival
(%)
|
Gemcitabine (ACCORD
11) (Conroy et al., 2011)
|
171
|
3.3
|
6.8
|
20
|
2
|
Gemcitabine (MPACT)
(Von Hoff et al., 2013; Goldstein et al., 2015)
|
430
|
3.7
|
6.6
|
22
|
5
|
Gemcitabine/REOLYSIN® (REO 017)
|
33
|
4.0
|
10.2
|
45
|
24
|
Of the 29 patients evaluable for clinical response, one patient
had a partial response (PR), 23 had stable disease (SD) and five
had progressive disease as their best response. This translated
into a clinical benefit rate (CBR) (complete response (CR) + PR +
SD) of 83%.
"This is the second cancer where we have confirmed that PD-L1 is
upregulated in target tumors following our collaborators initial
observations of PD-L1 upregulation in glioblastoma," said Dr.
Brad Thompson, President and CEO of
Oncolytics. "We are currently analyzing archived samples from
other completed studies and current samples from ongoing studies to
determine if this is a common effect to most cancers. A systemic
viral therapy that generally led to upregulation of PD-L1 would
allow increased use of anti PD-L1 drugs in cancers where there is
insufficient PD-L1 to make therapy possible."
REO 017 is a U.S. Phase 2, single-arm clinical trial using
intravenous administration of REOLYSIN® in combination
with gemcitabine (Gemzar®) in chemotherapy-naïve
patients with advanced or metastatic pancreatic cancer. Eligible
patients were treated with gemcitabine at 800 mg/m2 on
days 1 and 8, and REOLYSIN® at 1x1010
TCID50 administered IV on days 1, 2, 8 and 9 every 3
weeks. Tumor assessment was performed every two cycles. The trial
enrolled 33 evaluable patients (34 total) using a one sample,
two-stage design. In the first stage, 17 patients were to be
enrolled, and best response noted. If three or more
responses were observed (defined as CR, PR, or SD for 12 weeks or
more) among the 17 patients, the study would enroll an additional
16 patients for a total of at least 33 evaluable patients. As
previously disclosed, this initial endpoint was met after six
evaluable patients were enrolled. The primary objective of the
trial was to determine the CBR of intravenous multiple doses of
REOLYSIN® in combination with gemcitabine in
patients with advanced or metastatic pancreatic cancer. The
secondary objectives were to determine PFS, and to determine the
safety and tolerability of REOLYSIN® when
administered in combination with gemcitabine.
A copy of the poster presentation will be available on the
Oncolytics website at:
http://www.oncolyticsbiotech.com/for-investors/presentations.
About Oncolytics Biotech Inc.
Oncolytics is a
Calgary-based biotechnology
company focused on the development of oncolytic viruses as
potential cancer therapeutics. Oncolytics' clinical program
includes a variety of later-stage, randomized human trials in
various indications using REOLYSIN®, its proprietary
formulation of the human reovirus. 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 II single-arm clinical
trial in pancreatic 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.