- Data Accepted for Inclusion in the Presidential Symposium 2 on
Monday, September 29, 2014 -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep. 17, 2014--
Exelixis, Inc. (NASDAQ:EXEL) today announced that cobimetinib, an
Exelixis-discovered compound, will be the subject of a clinical data
presentation at the European Society for Medical Oncology (ESMO) 2014
Congress. During the meeting, which will be held from September 26-30,
2014, in Madrid, Spain, investigators will present initial data from
coBRIM, the ongoing phase 3 pivotal trial of cobimetinib in combination
with vemurafenib in patients with previously untreated BRAF V600
mutation-positive advanced melanoma.
On July 13, 2014, Exelixis announced positive top-line results from
coBRIM after being informed by Genentech, a member of the Roche Group
and Exelixis’ collaborator, that coBRIM met its primary endpoint,
delivering a statistically significant increase in progression-free
survival (PFS) for the combination of cobimetinib plus vemurafenib as
compared to vemurafenib alone. Roche has indicated that it will initiate
regulatory filings for the combination of cobimetinib and vemurafenib
before the end of the year.
The ESMO presentation details are as follows:
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Abstract Number:
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LBA5_PR
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Abstract Title:
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Phase 3, Double-Blind, Placebo-Controlled Study of Vemurafenib
Versus Vemurafenib + Cobimetinib in Previously Untreated BRAFV600
Mutation–Positive Patients With Unresectable Locally Advanced or
Metastatic Melanoma (NCT01689519)
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Presenter:
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Professor Grant McArthur, Peter MacCallum Cancer Centre, Victoria,
Australia
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Session:
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Presidential Symposium 2
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Date:
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Monday, September 29, 2014
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Time:
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4:00 – 5:20 p.m. local Madrid time (CEST)
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About the Combination of Cobimetinib and Vemurafenib
Cobimetinib is a selective inhibitor that blocks the activity of MEK, a
protein kinase that is part of a key pathway (the RAS-RAF-MEK-ERK
pathway) that promotes cell division and survival. This pathway is
frequently activated in human cancers including melanoma, where mutation
of one of its components (BRAF) causes abnormal activation in about 50%
of tumors. Tumors with BRAF mutations may develop resistance and
subsequently progress after treatment with a BRAF inhibitor. In
preclinical melanoma models, co-treatment with vemurafenib and the MEK
inhibitor cobimetinib can delay the emergence of resistant tumors. In
addition to the combination with vemurafenib in melanoma, cobimetinib is
also being investigated in combination with several investigational
medicines, including an immunotherapy, in several tumor types, including
non-small cell lung cancer and colorectal cancer.
About the Collaboration for Cobimetinib
Exelixis discovered cobimetinib internally and advanced the compound to
investigational new drug (IND) status. In late 2006, Exelixis entered
into a worldwide co-development agreement with Genentech, under
which Exelixis received initial upfront and milestone payments for
signing the agreement and submitting the IND. Exelixis was responsible
for development of cobimetinib through the determination of the maximum
tolerated dose in phase 1, at which point Genentech exercised its option
to further develop the compound.
In November 2013, Exelixis exercised its option to co-promote
cobimetinib, if approved, in the United States. Exelixis is entitled to
an initial equal share of U.S. profits and losses, which will decrease
as sales increase, and will share equally in the U.S. marketing and
commercialization costs. Exelixis is eligible to receive royalties on
any sales of the product outside the United States.
About Exelixis
Exelixis, Inc. is a biopharmaceutical company committed to developing
small molecule therapies for the treatment of cancer. Exelixis is
focusing its development and commercialization efforts primarily on
COMETRIQ® (cabozantinib), its wholly-owned inhibitor of
multiple receptor tyrosine kinases. Another Exelixis-discovered
compound, cobimetinib, a highly selective inhibitor of MEK, is being
evaluated by Roche and Genentech (a member of the Roche Group) in a
broad development program under a collaboration with Exelixis. For more
information, please visit the company's web site at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: the continued development and
clinical, therapeutic and commercial potential of cobimetinib in
combination with vemurafenib and other investigational medicines; future
coBRIM data presentations; future regulatory filings and potential
approvals; Exelixis’ future U.S. co-promotion efforts with Genentech;
the plan of Genentech and Exelixis to share U.S. profits and losses for
cobimetinib and U.S. marketing and commercialization costs for
cobimetinib; and Exelixis' potential receipt of royalties on net sales
of cobimetinib products outside the United States. Words such as “will,”
“initiate,” “can,” “entitled,” “share,” “estimated,” “eligible,” or
other similar expressions, identify forward-looking statements, but the
absence of these words does not necessarily mean that a statement is not
forward-looking. In addition, any statements that refer to expectations,
projections or other characterizations of future events or circumstances
are forward-looking statements. These forward-looking statements are
based upon Exelixis' current plans, assumptions, beliefs, expectations,
estimates and projections. Forward-looking statements involve risks and
uncertainties. Exelixis' actual results and the timing of events could
differ materially from those anticipated in the forward-looking
statements as a result of these risks and uncertainties, which include,
without limitation: risks related to the potential failure of
cobimetinib or cabozantinib to demonstrate safety and efficacy in
clinical testing; the availability of data at the expected times; the
clinical, therapeutic and commercial value of cobimetinib and
cabozantinib; Exelixis' dependence on its relationship with
Genentech/Roche with respect to cobimetinib and Exelixis’ ability to
maintain its rights under the collaboration; risks and uncertainties
related to regulatory review and approval processes and Exelixis’
compliance with applicable legal and regulatory requirements; the
general sufficiency of Exelixis’ capital and other resources and the
specific risk of unforeseen expenses that could diminish Exelixis’
financial ability to support its operations through the release of
top-line results from METEOR, Exelixis’ phase 3 pivotal trial of
cabozantinib in metastatic renal cell cancer; the uncertain timing and
level of expenses associated with the development of cabozantinib; risks
related to Exelixis’ ability to implement its previously announced
workforce reduction according to plan and its impact on Exelixis’
business; charges, expenses and cash expenditures resulting from the
referenced workforce reduction; market competition; changes in economic
and business conditions; and other factors discussed under the caption
“Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on July 31, 2014 and in
Exelixis' other filings with the SEC. The forward-looking statements
made in this press release speak only as of the date of this press
release. Exelixis expressly disclaims any duty, obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in
Exelixis' expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
Exelixis, the Exelixis logo, and COMETRIQ are registered U.S.
trademarks.
Source: Exelixis, Inc.
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor Relations
and Corporate Communications
shubbard@exelixis.com