SEATTLE,
April 7, 2014 /PRNewswire/ -
Oncothyreon Inc. (NASDAQ: ONTY) today announced that Merck KGaA,
Darmstadt, Germany, has initiated
the international Phase 3 START2 study, which is designed to assess
the efficacy and safety of the investigational MUC1
antigen-specific cancer immunotherapy tecemotide (also known as
L-BLP25) in patients with unresectable, locally advanced Stage III
non-small cell lung cancer (NSCLC). Merck KGaA, Darmstadt,
Germany, is developing tecemotide
under a license agreement with Oncothyreon.
The START2 study is a Phase 3, multicenter, 1:1
randomized, double-blind, placebo-controlled clinical trial
designed to assess the efficacy, safety and tolerability of
tecemotide in patients suffering from unresectable, locally
advanced (Stage IIIA or IIIB) NSCLC who have had a response or
stable disease after at least two cycles of platinum-based
concurrent chemoradiotherapy (CRT). Concurrent CRT - a combination
of chemotherapy and radiotherapy given at the same time - is the
current standard of care for most of these patients. The study is
expected to recruit approximately 1,000 patients. The primary
endpoint is overall survival (OS). Secondary endpoints include time
to symptom progression, progression-free survival and time to
progression. Merck KGaA, Darmstadt, Germany received Scientific Advice from the
European Medicines Agency (EMA) on the program and reached an
agreement with the U.S. Food and Drug Administration (FDA) on a
Special Protocol Assessment (SPA) for the trial.
START2 is based on the outcome of the prior
START trial. While the START trial did not meet the primary
endpoint of improving OS in the overall patient population, data
from an exploratory analysis of a predefined subgroup of patients,
who received tecemotide after concurrent CRT, showed that these
patients achieved a median OS of 30.8 months versus 20.6 months in
patients treated with placebo (n=806; HR: 0.78; 95% CI 0.64-0.95;
p=0.016).
Dr. John Orloff,
Global Head of Clinical Development for the biopharmaceutical
division of Merck KGaA, Darmstadt, Germany, commented, "There is clearly a very
real need for additional treatment options for people fighting
NSCLC. The results of the initial START study provided scientific
and clinical evidence to inform the design of this new pivotal
Phase 3 program. We are pleased that START2 is now underway, and
feel confident that this study will address the appropriate gaps in
understanding the potential role that tecemotide could play in the
management of patients living with unresectable stage III
NSCLC."
About Tecemotide
Tecemotide is an investigational MUC1
antigen-specific cancer immunotherapy that is designed to stimulate
the body's immune system to identify and target cells expressing
the cell-surface glycoprotein MUC1. MUC1 is expressed in many
cancers, including non-small cell lung cancer (NSCLC), and has
multiple roles in tumor growth and survival. Tecemotide is
currently being investigated in the Phase 3 START and INSPIRE
trials for the treatment of unresectable, locally advanced Stage
III NSCLC.
Merck KGaA, Darmstadt, Germany, obtained the exclusive worldwide
rights for development and commercialization of tecemotide from
Oncothyreon Inc., Seattle,
Washington, U.S., in 2007, in an agreement replacing prior
collaboration and supply agreements originally entered in 2001. In
Japan, Merck KGaA, Darmstadt,
Germany, entered into a
co-development and co-marketing agreement for tecemotide with Ono
Pharmaceutical Co., Ltd., Osaka,
Japan.
The START2 trial is a Phase 3, multicenter,
randomized, double-blind, placebo-controlled clinical trial
designed to assess the efficacy, safety and tolerability of
tecemotide in patients suffering from unresectable, locally
advanced (Stage IIIA or IIIB) NSCLC who have had a response or
stable disease after at least two cycles of platinum-based
concurrent chemoradiotherapy (CRT). The primary endpoint of START2
is overall survival.
The initial START Phase 3 trial is a
multicenter, randomized, double-blind, placebo-controlled clinical
trial designed to assess the efficacy, safety and tolerability of
tecemotide in patients suffering from unresectable, locally
advanced (Stage IIIA or IIIB) NSCLC who have had a response or
stable disease after at least two cycles of platinum-based
chemoradiotherapy (concurrent or sequential). The trial involves
1,239 patients in 33 countries. The primary endpoint of an
improvement in overall survival was not met in the START trial.
INSPIRE is a Phase 3, multicenter, randomized,
double-blind, placebo-controlled clinical trial designed to
evaluate the efficacy, safety and tolerability of tecemotide in
patients suffering from unresectable, locally advanced Stage IIIA
or IIIB NSCLC who have had a response or stable disease after at
least two cycles of platinum-based concurrent chemoradiotherapy.
INSPIRE is recruiting approximately 500 unresectable, locally
advanced Stage III NSCLC patients across China, Hong
Kong, Korea, Singapore and
Taiwan.
Tecemotide is currently under clinical
investigation and has not been approved for use in the U.S.,
Europe, Canada, or elsewhere. Tecemotide has not been
proven to be either safe or effective and any claims of safety and
effectiveness can be made only after regulatory review of the data
and approval of the labeled claims.
About Oncothyreon
Oncothyreon is a biotechnology company
specializing in the development of innovative therapeutic products
for the treatment of cancer. Oncothyreon's goal is to develop and
commercialize novel synthetic vaccines and targeted small molecules
that have the potential to improve the lives and outcomes of cancer
patients. For more information, visit www.oncothyreon.com.
Forward-Looking Statements
In order to provide Oncothyreon's investors
with an understanding of its current results and future prospects,
this release contains statements that are forward-looking. Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Words such as "believes," "anticipates," "plans," "expects,"
"will," "intends," "potential," "possible" and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements include Oncothyreon's expectations
regarding clinical development activities.
Forward-looking statements involve risks and
uncertainties related to Oncothyreon's business and the general
economic environment, many of which are beyond its control. These
risks, uncertainties and other factors could cause Oncothyreon's
actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing,
duration and results of clinical trials, the timing and results of
regulatory reviews, the safety and efficacy of our product
candidates, and the indications for which our product candidates
might be developed. There can be no guarantee that the results of
preclinical studies or clinical trials will be predictive of either
safety or efficacy in future clinical trials. Although Oncothyreon
believes that the forward-looking statements contained herein are
reasonable, it can give no assurance that its expectations are
correct. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement. For a detailed
description of Oncothyreon's risks and uncertainties, you are
encouraged to review the documents filed with the securities
regulators in the United States on
EDGAR and in Canada on SEDAR.
Oncothyreon does not undertake any obligation to publicly update
its forward-looking statements based on events or circumstances
after the date hereof.
Additional information relating to Oncothyreon
can be found on EDGAR at www.sec.gov and on SEDAR at
www.sedar.com.
SOURCE Oncothyreon Inc.