– Results are the subject of a poster discussion presentation at ESMO
2016 Congress on Monday, October 10 –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 7, 2016--
Exelixis, Inc. (NASDAQ:EXEL) today announced that its collaborator
Genentech, a member of the Roche Group, will present preliminary results
from a phase 1b clinical trial evaluating the safety and clinical
activity of the triple combination of cobimetinib, vemurafenib, and
atezolizumab in patients with previously untreated BRAF V600
mutation-positive advanced melanoma. The results will be the subject of
a poster discussion presentation (Abstract #1109PD) at the European
Society of Medical Oncology (ESMO) 2016 Congress, which is being held
October 7-11 in Copenhagen, Denmark. Patrick Hwu, M.D., chair of the
Department of Melanoma Medical Oncology at the University of Texas M.D.
Anderson Cancer Center, Houston, Texas, will present the results during
a session on Monday, October 10, 2016, beginning at 11:00 a.m. CEST.
“Cobimetinib and vemurafenib is FDA-approved to treat specific forms of
BRAF V600 mutation-positive unresectable or metastatic melanoma and has
been associated with significant improvements in progression-free
survival, overall survival and objective response rate as compared to
vemurafenib alone,” said Michael M. Morrissey, Ph.D., president and
chief executive officer of Exelixis. “The preliminary results to be
presented at the ESMO Congress suggest that adding atezolizumab to the
combination regimen is associated both with a manageable safety profile
and promising antitumor activity.”
The primary objective of the phase 1b trial is the evaluation of the
safety and tolerability of the triple combination. Secondary endpoints
include progression-free survival (PFS), overall survival (OS),
objective response rate (ORR), best overall response, and duration of
response, as well as additional exploratory objectives. Patients in the
trial receive the triple combination of cobimetinib, vemurafenib, and
atezolizumab after a 28-day run-in cycle of combination cobimetinib and
vemurafenib. Atezolizumab is administered intravenously at 800 mg every
two weeks.
As of the June 15, 2016 data cut-off, 30 patients with previously
untreated BRAF V600 mutation-positive unresectable or advanced melanoma
who had received at least one dose of atezolizumab were evaluable for
safety. The median follow-up for safety was 3.9 months, with a range of
0.7 to 16.8 months. All-grade AEs occurring in greater than 20 percent
of patients and reported as related to cobimetinib and/or vemurafenib
and/or atezolizumab included elevated liver enzymes, fatigue,
arthralgia, diarrhea, flu-like symptoms, photosensitivity, increased
blood alkaline phosphatase, fever and pyrexia. Twelve patients had
cobimetinib- and/or vemurafenib and/or atezolizumab-related grade 3/4
AEs during the triple combination period; all resolved after appropriate
intervention.
Twenty-nine patients had received at least one dose of atezolizumab and
undergone at least one on-treatment, post baseline tumor assessment. The
ORR, a secondary endpoint, was 83 percent with 24 patients achieving a
response (fifteen of which were confirmed as of the data cutoff). Three
patients (10 percent) achieved complete responses and 21 patients had
partial responses (72 percent). All but one subject in the trial had a
reduction of tumor burden. Median duration of response and PFS were not
evaluable as a result of limited follow-up time.
Immune biomarkers potentially predictive of clinical responses were
evaluated in this phase 1b trial. Increases in CD8+ T cells in the tumor
were observed following cobimetinib and vemurafenib treatment during the
run-in period.
A pivotal placebo-controlled phase 3 trial evaluating the combination of
cobimetinib, vemurafenib and atezolizumab compared to cobimetinib,
vemurafenib and placebo was recently posted on ClinicalTrials.gov.
Sponsored by Roche, the full title of study NCT02908672 is “A Study of
Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus
Cobimetinib and Vemurafenib in Previously Untreated BRAFv600
Mutation-Positive Participants With Metastatic or Unresectable Locally
Advanced Melanoma.” Exelixis expects to share additional details of this
trial as they become available from its collaborator Roche.
Cobimetinib is a selective inhibitor of MEK that was discovered by
Exelixis and is the subject of a worldwide collaboration agreement
between Exelixis and Genentech. Cobimetinib is approved in multiple
countries to treat specific forms of BRAF V600 mutation-positive
unresectable or metastatic melanoma, in combination with vemurafenib.
Atezolizumab is an anti-PD-L1 antibody developed by Genentech that
received FDA approval to treat previously treated bladder cancer in May
2016.
Additional Cobimetinib Data Presented at the ESMO 2016 Congress
The poster discussion presentation in advanced melanoma is one of seven
cobimetinib abstracts being presented at the ESMO 2016 Congress.
Additional data presentations include studies of cobimetinib in
combination with other therapies to treat metastatic colorectal cancer
and triple-negative breast cancer and BRAF-mutant melanoma. For full
logistical information on these other presentations, please see
Exelixis’ ESMO announcement press release issued on August 31, 2016,
available online here.
About the Cobimetinib Development Collaboration
Exelixis discovered cobimetinib internally and advanced the compound to
investigational new drug (IND) status. In late 2006, Exelixis entered
into a worldwide collaboration agreement with Genentech, under which
Exelixis received initial upfront and milestone payments for signing the
agreement and submitting the IND. Following the determination of the
maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its
option to further develop cobimetinib.
Under the terms of the collaboration, Exelixis is entitled to an initial
equal share of U.S. profits and losses, which will decrease as sales
increase, and shares U.S. commercialization costs. In November 2013,
Exelixis exercised its option to co-promote cobimetinib in the United
States and fields 25 percent of the U.S. sales force, closely
coordinating its efforts with Genentech. Outside of the United States,
Exelixis is eligible to receive royalties on any sales.
Cobimetinib is now approved in multiple countries, including the United
States, European Union, Switzerland, Canada, Australia and Brazil, to
treat specific forms of BRAF mutation-positive unresectable or
metastatic melanoma, in combination with vemurafenib. The trade name for
cobimetinib is COTELLIC®. Further country approvals
are anticipated in 2016 and beyond. Cobimetinib is also the subject of a
clinical development program aimed at evaluating its potential in
combination with a variety of investigational and approved therapies in
disease settings including metastatic melanoma, triple-negative breast
cancer and advanced solid tumors.
COTELLIC® Indication
COTELLIC (cobimetinib) is a prescription medicine that is used with the
medicine Zelboraf® (vemurafenib), to treat a type of
skin cancer called melanoma that has spread to other parts of the body
or cannot be removed by surgery, and that has a certain type of abnormal
“BRAF” gene.
A patient’s healthcare provider will perform a test for the BRAF gene to
make sure that COTELLIC is right for them. It is not known if COTELLIC
is safe and effective in children under 18 years of age.
COTELLIC® Important Safety Information
Patients should avoid sunlight during treatment with COTELLIC and
Zelboraf. COTELLIC and Zelboraf can make a patient’s skin sensitive to
sunlight. They may burn more easily and get severe sunburns. When a
patient goes outside, they should wear clothes that protect their skin,
including their head, face, hands, arms and legs. They should use lip
balm and a broad-spectrum sunscreen with SPF 30 or higher.
COTELLIC and Zelboraf may cause serious side effects, including risk of
new skin cancers, risk of other cancers, bleeding problems, heart
problems, allergic reactions, severe rash and other severe skin
reactions, eye problems, changes in the electrical activity of the heart
(QT prolongation), liver problems or liver injury, muscle problems
(rhabdomyolysis), skin sensitivity to sunlight (photosensitivity),
worsening side effects from radiation treatment, and kidney injury.
Patients should tell their doctor if they are pregnant or plan to become
pregnant, as COTELLIC and Zelboraf can harm an unborn baby. Females who
are able to become pregnant should use effective birth control during
treatment with COTELLIC and Zelboraf and for two weeks after the final
dose of COTELLIC or Zelboraf (whichever is taken later).
Patients should not breastfeed during treatment and for two weeks after
the final dose of COTELLIC or Zelboraf (whichever is taken later).
Patients should talk to their healthcare provider about the best way to
feed their baby during this time.
Patients should tell their healthcare provider about all the medicines
they take. Some types of medicines will affect the blood levels of
COTELLIC.
Common side effects of COTELLIC in combination with Zelboraf include
diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting.
COTELLIC and Zelboraf can also cause changes in blood test results.
Patients should tell their healthcare provider if they have any side
effect that bothers them or that does not go away. These are not all the
possible side effects of COTELLIC and Zelboraf.
Patients should call their doctor for medical advice about side effects.
Patients may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Patients may also report side effects to Genentech at (888) 835-2555.
Please see both Full COTELLIC Prescribing Information and Patient
Information and Full Zelboraf Prescribing Information and Medication
Guide for additional Important Safety Information at www.cotellic.com
and www.zelboraf.com.
About Exelixis
Exelixis, Inc. (Nasdaq:EXEL) is a biopharmaceutical company committed to
the discovery, development and commercialization of new medicines with
the potential to improve care and outcomes for people with cancer. Since
its founding in 1994, three medicines discovered at Exelixis have
progressed through clinical development to receive regulatory approval.
Currently, Exelixis is focused on advancing cabozantinib, an inhibitor
of multiple tyrosine kinases including MET, AXL and VEGF receptors,
which has shown clinical anti-tumor activity in more than 20 forms of
cancer and is the subject of a broad clinical development program. Two
separate formulations of cabozantinib have received regulatory approval
to treat certain forms of kidney and thyroid cancer and are marketed for
those purposes as CABOMETYX™ tablets (U.S. and EU) and COMETRIQ®
capsules (U.S. and EU), respectively. Another Exelixis-discovered
compound, COTELLIC® (cobimetinib), a selective inhibitor of
MEK, has been approved in major territories including the United States
and European Union, and is being evaluated for further potential
indications by Roche and Genentech (a member of the Roche Group) under a
collaboration with Exelixis. For more information on Exelixis, please
visit www.exelixis.com
or follow @ExelixisInc on Twitter.
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements, including,
without limitation, statements related to: the presentation of data from
a phase 1b clinical trial evaluating the safety and clinical activity of
the triple combination of cobimetinib, vemurafenib, atezolizumab at the
ESMO 2016 Congress; the clinical and therapeutic potential of adding
atezolizumab to the combination regimen of cobimetinib and vemurafenib;
the potential for cobimetinib in combination with a variety of
investigational and approved therapies in disease settings, including
metastatic melanoma, triple-negative breast cancer and advanced solid
tumors; the financial terms of Exelixis’ collaboration for cobimetinib
with Genentech, including, the plan to share U.S. profits and losses for
cobimetinib, and Exelixis’ potential receipt of royalties on sales of
cobimetinib products outside the U.S.; further country approvals of
cobimetinib in combination with vemurafenib anticipated in 2016 and
beyond; Exelixis’ commitment to the discovery, development and
commercialization of new medicines with the potential to improve care
and outcomes for people with cancer; Exelixis’ focus on advancing
cabozantinib; and the continued development of cobimetinib. Words such
as “will,” “to be,” suggest,” “promising,” “eligible,” “anticipated,”
“potential,” “committed,” “focused,” 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. 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: the availability of data at the referenced times; risks
related to the potential failure of cobimetinib to demonstrate safety
and efficacy in clinical testing; Exelixis’ dependence on its
relationship with Genentech/Roche with respect to cobimetinib and
ability to maintain its rights under the collaboration; the degree of
market acceptance of and the availability of coverage and reimbursement
for COTELLIC; the risk that unanticipated developments could adversely
affect the commercialization of COTELLIC; risks related to the potential
failure of cabozantinib to demonstrate safety and efficacy in clinical
testing; market competition; changes in economic and business
conditions; and other factors discussed under the caption “Risk Factors”
in Exelixis’ annual report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on August 3, 2016, and in Exelixis’ future
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, COMETRIQ and COTELLIC are registered
U.S. trademarks, and CABOMETYX is a U.S. trademark.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161007005206/en/
Source: Exelixis, Inc.
Investors Contact:
Exelixis, Inc.
Susan
Hubbard, 650-837-8194
Investor Relations & Public Affairs
shubbard@exelixis.com
or
Media
Contact:
For Exelixis, Inc.
Hal Mackins,
415-994-0040
hal@torchcomllc.com
