BOULDER, Colo., July 22, 2015 /PRNewswire/ -- AstraZeneca
today announced that the Phase 3 SUMIT study of selumetinib in
combination with dacarbazine for the treatment of patients with
metastatic uveal melanoma did not meet its primary endpoint of
progression free survival. This combination therapy showed an
adverse event profile generally consistent with current knowledge
of the safety profiles of dacarbazine and selumetinib. A full
evaluation of the data is ongoing.
Selumetinib is a MEK inhibitor in late-stage development, with a
primary Phase 3 program in second-line KRAS-mutant advanced
non-small cell lung cancer in combination with docetaxel.
Selumetinib is also being investigated in a Phase 3 study in
differentiated thyroid cancer and in a Phase 2 registration study
in patients with neurofibromatosis Type 1.
Antoine Yver, Head of Oncology,
Global Medicines Development at AstraZeneca said: "Selumetinib is
supported by a strong development program with different scientific
rationale in multiple tumor types as both monotherapy and in
alternative combinations. The findings from SUMIT have no impact on
the other studies and we look forward to presenting the data in due
course."
About Selumetinib and Uveal Melanoma
Selumetinib is an
oral small molecule MEK inhibitor invented by Array BioPharma
(NASDAQ: ARRY) and licensed to AstraZeneca in 2003.
AstraZeneca is responsible for development and commercialization of
selumetinib. Selumetinib inhibits the MEK enzyme in the
RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumor from
growing.
The Selumetinib in Uveal Melanoma
Investigator Trial (SUMIT) is a randomized,
double-blind, placebo controlled trial being carried out in 45
centers, across 11 countries.
Uveal melanoma is an orphan disease in which cancer cells grow
in the tissues of the eye. It is the most common primary
intraocular malignancy in adults and comprises 5% of all melanomas.
There are currently no effective treatments for advanced uveal
melanoma and in April 2015,
selumetinib was granted Orphan Drug Designation by the US Food and
Drug Administration in recognition of the need for new, safe and
effective therapies for the disease.
About AstraZeneca
AstraZeneca is a global,
innovation-driven biopharmaceutical business that focuses on the
discovery, development and commercialization of prescription
medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology,
infection and neuroscience diseases. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. For more information please visit:
www.astrazeneca.com.
About Array BioPharma
Array BioPharma Inc. is a
biopharmaceutical company focused on the discovery, development and
commercialization of targeted small molecule drugs to treat
patients afflicted with cancer. Six registration studies are
currently advancing beyond the SUMIT trial. These programs include
three cancer drugs, binimetinib (MEK162 / wholly-owned),
encorafenib (LGX818 / wholly-owned) and selumetinib
(AstraZeneca). For more information on Array, please go to
www.arraybiopharma.com.
Forward-Looking Statement
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
about the future development plans of selumetinib and the timing of
the announcement of further results of clinical trials for
selumetinib, expectations that events will occur that will result
in greater value for Array, and the potential for the results of
ongoing preclinical and clinical trials to support regulatory
approval or the marketing success of selumetinib. These
statements involve significant risks and uncertainties, including
those discussed in our most recent annual report filed on Form
10-K, in our quarterly reports filed on Form 10-Q, and in other
reports filed by Array with the Securities and Exchange Commission.
Because these statements reflect our current expectations
concerning future events, our actual results could differ
materially from those anticipated in these forward-looking
statements as a result of many factors. These factors include, but
are not limited to, our ability to effectively and timely conduct
clinical trials in light of increasing costs and difficulties in
locating appropriate trial sites and in enrolling patients who meet
the criteria for certain clinical trials; risks associated with our
dependence on third-party service providers to successfully conduct
clinical trials within and outside the
United States; our ability to achieve and maintain
profitability and maintain sufficient cash resources; and our
ability to attract and retain experienced scientists and
management. We are providing this information as of July 22, 2015. We undertake no duty to update any
forward-looking statements to reflect the occurrence of events or
circumstances after the date of such statements or of anticipated
or unanticipated events that alter any assumptions underlying such
statements.
CONTACT:
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Tricia
Haugeto
|
|
(303)
386-1193
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thaugeto@arraybiopharma.com
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SOURCE Array BioPharma Inc.