--Randomized REOLYSIN® Data
Correlates Genetic Status to Patient Outcomes--
CALGARY, May 19, 2016 /PRNewswire/ - Oncolytics Biotech
Inc. ("Oncolytics" or the "Company") (TSX: ONC)
(OTCQX: ONCYF) (FRA: ONY) today announced preliminary data from a
randomized, Phase II clinical study of REOLYSIN®.
Patients with non-squamous cell histology were treated with
REOLYSIN® given in combination with pemetrexed (Arm A)
versus pemetrexed alone (Arm B). Patients with squamous cell
histology were treated with REOLYSIN® given in
combination with docetaxel (Arm C) versus docetaxel alone (Arm
D). The study is being sponsored by the National Cancer
Institute of Canada
("NCIC") Clinical Trials Group ("CTG") at Queen's
University in Kingston, Ontario.
The preliminary analysis includes data from an NCIC study summary
report, and follows the release of an abstract to be presented at
the American Society of Clinical Oncology ("ASCO") Annual
Meeting, which will run from June 3-7,
2016 in Chicago, IL.
Highlights
|
Median Progression
Free Survival (months)
|
Median Overall
Survival (months)1
|
|
Test
Arms
(Arm A+C)
(95% CI)
|
Control Arms
(Arm B+D)
(95% CI)
|
Hazard
Ratio
(95% CI)
|
Test
Arms
(Arm A+C)
(95% CI)
|
Control Arms
(Arm B+D)
(95% CI)
|
Hazard
Ratio
(95%
CI)
|
|
EGFR2
|
5.16
(0.76-8.71)
(n=8)
|
4.63
(1.51-7.03)
(n=5)
|
0.54
(0.13-2.22)
|
18.66
(1.38-26.84)
(n=8)
|
7.49
(4.63-16.79)
(n=5)
|
0.37
(0.08-1.71)
|
|
TP532
|
4.07
(2.63-6.21)
(n=24)
|
2.40
(1.28-2.99)
(n=21)
|
0.58
(0.31-1.08)
|
8.74
(6.83-13.93)
(n=23)
|
6.14
(3.02-8.18)
(n=21)
|
0.55
(0.28-1.07)
|
|
Female
Patients
|
3.98
(2.66-5.39)
(n=41)
|
2.84
(1.51-4.34)
(n=34)
|
0.59
(0.36-0.98)
|
8.38
(5.36-10.38)
(n=41)
|
7.59
(5.59-10.45)
(n=34)
|
0.85
(0.49-1.46)
|
|
Male
Patients
|
2.56
(1.45-3.94)
(n=36)
|
2.69
(2.46-4.24)
(n=41)
|
1.34
(0.83-2.14)
|
7.66
(4.37-10.94)
(n=36)
|
7.26
(4.86-10.78)
(n=41)
|
1.0
(0.60-1.68)
|
|
Overall
|
2.96
(2.56-4.17)
(n=77)
|
2.83
(2.50-3.98)
(n=75)
|
0.93
(0.66-1.31)
|
8.12
(5.85-9.40)
(n=77)
|
7.39
(5.72-9.43)
(n=75)
|
0.94
(0.64-1.37)
|
|
Source: Report of
Statistical Analysis for NCIC CTG Protocol Number
IND.211
|
|
1
This was an interim analysis, as 38
(25.0%) patients out of a total of 152 patients were alive at the
time of data cut-off.
Survival outcomes noted could change at final analysis.
|
|
2
Mutated
|
|
|
"It's very encouraging to see both a genetic and gender linkage
to progression free survival and overall survival in these
difficult to treat patient populations," said Dr. Brad Thompson, President and CEO of Oncolytics
Biotech Inc. "This is the first randomized data we have generated
in lung cancers that correlates genetic status to patient
outcomes."
The investigators concluded that REOLYSIN® was
reasonably well tolerated at the dose and schedule administered
with pemetrexed or docetaxel and that no new safety signals were
seen. They noted it was of interest that female patients in the
REOLYSIN®-containing arms did better than in the
standard treatment arms and that in a subgroup analysis that EGFR
mutation and p53 mutation status was associated with a trend to
improved progression free survival.
About IND 211
IND 211 is an open-label, randomized,
non-blinded Phase II study of intravenously-administered
REOLYSIN® in patients with advanced or metastatic
non-small cell lung cancer. Patients with squamous cell histology
were treated with either REOLYSIN® given in
combination with docetaxel (test arm) or docetaxel alone (control
arm). Patients with non-squamous cell histology were treated with
either REOLYSIN® given in combination with pemetrexed
(test arm) versus pemetrexed alone (control arm). After a patient
safety run-in, a total of approximately 150 response-evaluable
patients were enrolled.
The primary objective is progression free survival. Secondary
objectives include the tolerability and toxicity of the treatment
combination, progression rates at three months, objective response
rate, and overall survival. Other objectives include the
measurement of molecular factors which may be prognostic or
predictive of response.
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 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements, including the
Company's expectations related to the randomized Phase II study in
patients with non-small cell lung 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 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.