Oncothyreon Announces Initiation of Phase 1 Trial of ONT-380 in Combination
with Trastuzumab in Patients with Brain Metastases from HER2+ Breast Cancer
SEATTLE, WA, Sept. 3, 2013
SEATTLE, WA, Sept. 3, 2013 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY)
today announced the initiation of an investigator-sponsored trial of ONT-380
in combination with trastuzumab (Herceptin®) in patients with brain metastases
from HER2+ breast cancer. The trial is being conducted under the sponsorship
of the Dana-Farber Cancer Institute, Boston, Massachusetts. ONT-380 (also
known as ARRY-380) is an orally active, reversible and selective
small-molecule HER2 inhibitor being developed by Oncothyreon in collaboration
with Array BioPharma Inc., Boulder, Colorado.
The Phase 1 trial is a dose-escalation trial in up to 50 patients. The
primary objectives are to determine the maximum-tolerated dose and recommended
Phase 2 dose and schedule of ONT-380 in combination with trastuzumab in
patients with HER2+ breast cancer and central nervous system (CNS)
metastases. Secondary objectives include CNS objective response rate by both
RECIST and volumetric criteria, progression-free survival and overall
survival. The study will be conducted in two parallel arms with two dose
regimens of ONT-380, either once-daily or twice-daily, in combination with
standard dose trastuzumab.
"ONT-380 has demonstrated superior activity, based on overall survival,
compared to Tykerb^® (lapatinib) and to the investigational drug, neratinib,
in an intracranial HER2+ breast cancer xenograft model," said Robert L.
Kirkman, M.D., President and CEO of Oncothyreon. "This provides a strong
rationale to explore whether ONT-380 can provide benefit to patients with
brain metastases, and we are pleased that the Dana Farber Cancer Institute is
undertaking this trial."
"CNS metastases, which occur in one-third to one-half of women with metastatic
HER2+ breast cancer, remain a significant clinical problem," said Nancy U.
Lin, M.D., Principal Investigator of the Phase 1 trial and Clinical Director,
Breast Oncology, Dana-Farber Cancer Institute. "There is an urgent need for
new therapies to treat patients with brain metastases from breast cancer, and
we are excited to begin this study of ONT-380".
ONT-380 is an orally active, reversible and selective HER2 inhibitor. In
multiple preclinical tumor models, ONT-380 was well tolerated and demonstrated
significant dose-related tumor growth inhibition that was superior to
Herceptin and Tykerb. Additionally, in these models, ONT-380 demonstrated
synergistic or additive tumor growth inhibition when dosed in combination with
the standard-of-care therapeutics Herceptin or Taxotere® (docetaxel).
A Phase 1 trial of ONT-380, with both dose-escalation and expansion
components, has been completed in 50 patients, 43 of whom had HER2+ metastatic
breast cancer. All HER2+ breast cancer patients had progressed on a
trastuzumab-containing regimen. In addition, over 80% had been treated with
lapatinib, with many having progressed on therapy. In this study, ONT-380
demonstrated an acceptable safety profile; treatment-related adverse events
were primarily Grade 1. Because ONT-380 is selective for HER2 and does not
inhibit EGFR, there was a low incidence and severity of treatment-related
diarrhea, rash and fatigue. Additionally, there were no treatment-related
cardiac events or Grade 4 treatment-related adverse events reported. The
maximum tolerated dose of ONT-380 established in this Phase 1 trial was 600 mg
twice daily (BID). Twenty-two HER2+ breast cancer patients with measurable
disease were treated with ONT-380 at doses greater than or equal to 600 mg
BID. In this heavily pretreated patient population, there was a clinical
benefit rate (partial response [n = 3] plus stable disease for at least 6
months [n = 3]) of 27%. Notably, two of the patients with partial responses
during treatment with ONT-380 had confirmed progressions while on prior
lapatinib- and trastuzumab-containing regimens.
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.
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
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
Additional information relating to Oncothyreon can be found on EDGAR at
www.sec.gov and on SEDAR at www.sedar.com.
SOURCE Oncothyreon Inc.
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