– Study did not meet its primary endpoint of improving overall
survival versus regorafenib –
– Results will be submitted for presentation at an upcoming
medical meeting –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 10, 2018--
Exelixis, Inc. (Nasdaq:EXEL) today announced that IMblaze370, the phase
3 pivotal trial of atezolizumab (TECENTRIQ®), an anti-PDL1
antibody discovered and developed by Genentech, a member of the Roche
Group, and cobimetinib (COTELLIC®), an Exelixis-discovered
MEK inhibitor, did not meet its primary endpoint. Genentech, Exelixis’
collaborator and sponsor of the IMblaze370 trial, informed the company
that the combination of atezolizumab and cobimetinib did not deliver an
improvement in overall survival (OS) versus regorafenib. The IMblaze370
trial evaluated the combination in patients with difficult-to-treat,
locally advanced or metastatic colorectal cancer (CRC) whose disease had
progressed or who were intolerant to at least two systemic chemotherapy
The safety profile for the combination appeared consistent with the
known safety profile of each individual medicine, and no new safety
signals were identified with the combination. Genentech will further
examine results from IMblaze370 and plans to present the data at an
upcoming medical meeting.
“We are disappointed that the IMblaze370 trial did not reach a positive
conclusion,” said Michael M. Morrissey, Ph.D., President and Chief
Executive Officer of Exelixis. “Metastatic colorectal cancer is an
aggressive and difficult-to-treat disease, and patients and clinicians
would be well served by additional treatment options. We will continue
to work with Genentech on the evaluation of cobimetinib’s potential in
other tumor types, including in melanoma, in which there are two ongoing
phase 3 pivotal trials. Separately, Exelixis remains focused on and
committed to maximizing the potential of the cabozantinib franchise
through our commercial activities and ongoing clinical development
program evaluating the compound alone, or in combination with immune
checkpoint inhibitors, across numerous tumor types.”
Other ongoing late-stage clinical trials of cobimetinib include:
IMspire150 TRILOGY, a fully enrolled study of cobimetinib, vemurafenib,
and atezolizumab in previously untreated patients with BRAF
V600-positive metastatic melanoma; and IMspire170, which is evaluating
cobimetinib and atezolizumab in BRAF V600-wild type metastatic melanoma.
About the IMblaze370 Phase 3 Pivotal Trial
In early June 2016, shortly before the initial presentation of data from
the phase 1b clinical trial of cobimetinib and atezolizumab at the 2016
Annual Meeting of the American Society of Clinical Oncology, Genentech
initiated IMblaze370, a phase 3 pivotal trial of cobimetinib plus
atezolizumab and atezolizumab monotherapy versus regorafenib in patients
with locally advanced or metastatic CRC who had received at least two
prior regimens of chemotherapy. The trial enrolled 363 patients who were
randomized 2:1:1 to receive cobimetinib plus atezolizumab, atezolizumab
alone, or regorafenib.
Patients in the combination arm received cobimetinib on days 1 to 21
plus atezolizumab on day 1 and day 15 in a 28-day cycle. Patients in the
experimental monotherapy arm received atezolizumab on day 1 of each
21-day cycle. Patients in the control arm received regorafenib on days 1
to 21 in a 28-day cycle. All patients continued to receive study drug
until clinical benefit was no longer observed.
The primary endpoint of IMblaze370 is OS; key secondary endpoints
include progression-free survival, objective response rate, and duration
of response. IMblaze370 completed enrollment in the first quarter of
2017. More information about IMblaze370 is available at www.clinicaltrials.gov.
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. Outside of the United
States, Exelixis is eligible to receive royalties on any sales.
Cobimetinib is now approved in multiple countries, including the U.S.,
European Union, Switzerland, Canada, Australia and Brazil, to treat
specific forms of BRAF mutation-positive unresectable or metastatic
melanoma, in combination with vemurafenib (ZELBORAF®). The
trade name for cobimetinib is COTELLIC®. 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 colorectal carcinoma.
Important: If a patient’s healthcare provider prescribes ZELBORAF
(vemurafenib), the patient should also read the Medication Guide that
comes with ZELBORAF.
COTELLIC is a prescription medicine that is used with the medicine
ZELBORAF to treat a type of skin cancer called melanoma:
that has spread to other parts of the body or cannot be removed by
that has a certain type of abnormal “BRAF” gene.
A patient’s healthcare provider will perform a test to make sure that
COTELLIC is right for the patient. It is not known if COTELLIC is safe
and effective in children under 18 years of age.
Important Safety Information
Before taking COTELLIC, patients should tell their healthcare
provider about all of their medical conditions, including if they:
have skin problems or history of skin problems, other than melanoma
have bleeding problems, any medical conditions and/or on any
medications that increase the risk of bleeding
have heart problems
have eye problems
have liver problems
have muscle problems
are pregnant or plan to become pregnant. COTELLIC can harm an unborn
Females who are able to become pregnant should use effective birth
control during treatment with COTELLIC, and for two weeks after
the final dose of COTELLIC.
Patients should talk to their healthcare provider about birth
control methods that may be right for them.
Patients should tell their healthcare provider right away if they
become pregnant or think they are pregnant during treatment with
are breastfeeding or plan to breastfeed. It is not known if COTELLIC
passes into breast milk. Patients should not breastfeed during
treatment with COTELLIC and for two weeks after the final dose of
COTELLIC. 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, including prescription and over-the-counter
medicines, vitamins and herbal supplements. Certain medicines may affect
the blood levels of COTELLIC.
Patients should know the medicines they take and keep a list of them to
show their healthcare provider and pharmacist when they get a new
How should patients take COTELLIC?
Patients should take COTELLIC exactly as their healthcare provider
tells them. Patients should not change their dose or stop taking
COTELLIC unless their healthcare provider tells them to.
Patients should take COTELLIC one time a day for 21 days, followed by
seven days off treatment, to complete a 28-day treatment cycle.
Patients can take COTELLIC with or without food.
If a patient vomits after taking their dose of COTELLIC, they should
not take an additional dose.
If a patient misses a dose of COTELLIC, they should take their next
dose as scheduled.
What should patients avoid during treatment with COTELLIC?
Patients should avoid sunlight during treatment with COTELLIC. COTELLIC
can make a patient’s skin sensitive to sunlight. They may burn more
easily and get severe sunburns. To help protect against sunburn:
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
What are the possible side effects of COTELLIC?
COTELLIC may cause serious side effects, including:
Risk of new skin cancers. COTELLIC may cause new skin cancers
(cutaneous squamous cell carcinoma, keratoacanthoma or basal cell
Patients should check their skin regularly
and tell their healthcare provider right away if they have any skin
skin sore or reddish bump that bleeds or does not heal
change in size or color of a mole
A patient’s healthcare provider should check the patient’s skin before
they start taking COTELLIC, and every two months during treatment with
COTELLIC. A patient’s healthcare provider may continue to check the
patient’s skin for six months after the patient stops taking COTELLIC.
A patient’s healthcare provider should also check for cancers that may
not occur on the skin. Patients should tell their healthcare provider
about any new symptoms that develop during treatment with COTELLIC.
Bleeding problems. COTELLIC can cause serious bleeding problems.
should call their healthcare provider and get medical attention right
away if they get any signs of bleeding, including:
red or black stools (looks like tar)
blood in their urine
cough up or vomit blood
stomach (abdominal) pain
unusual vaginal bleeding
dizziness or weakness
Heart problems. A patient’s healthcare provider should do tests
before and during treatment to check the patient’s heart function.
Patients should tell their healthcare provider if they get any of
these signs and symptoms of heart problems:
persistent coughing or wheezing
shortness of breath
swelling of their ankles and feet
increased heart rate
Severe rash. Patients should tell their healthcare provider
right away if they get any of these symptoms:
a rash that covers a large area of their body
Eye problems. Patients should tell their healthcare provider
right away if they get any of these symptoms:
partly missing vision or loss of vision
any other vision changes
A patient’s healthcare provider should check the patient’s eyes if the
patient notices any of the symptoms above.
Liver problems. A patient’s healthcare provider should do blood
tests to check the patient’s liver function before and during
treatment. Patients should tell their healthcare provider right away
if they get any of these symptoms:
yellowing of their skin or the white of their eyes
dark or brown (tea color) urine
nausea or vomiting
feeling tired or weak
loss of appetite
Muscle problems (rhabdomyolysis). COTELLIC can cause muscle
problems that can be severe. Treatment with COTELLIC may increase the
level of an enzyme in the blood called creatine phosphokinase (CPK)
and may be a sign of muscle damage. A patient’s healthcare provider
should do a blood test to check the patient’s levels of CPK before and
during treatment. Patients should tell their healthcare provider right
away if they get any of these symptoms:
muscle aches or pain
muscle spasms and weakness
dark, reddish urine
Skin sensitivity to sunlight (photosensitivity). Skin
sensitivity to sunlight during treatment with COTELLIC is common and
can sometimes be severe. Patients should tell their healthcare
provider if they get any of these symptoms:
red, painful, itchy skin that is hot to touch
bumps or tiny papules
thickened, dry, wrinkled skin
See “What should patients avoid during treatment with COTELLIC?” for
information on protecting the skin during treatment with COTELLIC.
The most common side effects of COTELLIC include:
A patient’s healthcare provider will take blood tests during
treatment with COTELLIC. The most common changes to blood tests include:
increased blood levels of liver enzymes (GGT, ALT or AST)
increased blood level of enzyme from muscle (creatine phosphokinase)
decreased blood level of phosphate, sodium or potassium
increased blood level of liver or bone enzyme (alkaline phosphatase)
decreased blood level of a type of white blood cell (lymphocyte)
These are not all the possible side effects of COTELLIC. 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 Full COTELLIC Prescribing Information and Patient
Information for additional Important Safety Information at www.COTELLIC.com.
TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib)
and ZELBORAF® (vemurafenib) are registered trademarks of
Genentech, a member of the Roche Group.
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in model
genetic systems, we established a broad drug discovery and development
platform that has served as the foundation for our continued efforts to
bring new cancer therapies to patients in need. We discovered our lead
compounds, cabozantinib and cobimetinib, and advanced them into clinical
development before entering into partnerships with leading
biopharmaceutical companies in our efforts to bring these medicines to
patients globally. We are steadfast in our commitment to prudently
reinvest in our business to maximize the potential of our pipeline. We
intend to supplement our existing therapeutic assets with targeted
business development activities and internal drug discovery – all to
deliver the next generation of Exelixis medicines and help patients
recover stronger and live longer. Exelixis recently earned a spot on
Deloitte’s Technology Fast 500 list, a yearly award program honoring the
500 fastest-growing companies over the past four years. For more
information about 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: Genentech’s intent to further
examine results from IMblaze and plans to present the data at an
upcoming medical meeting; Exelixis’ plan to continue to work with
Genentech on the evaluation of cobimetinib’s potential in other tumor
types; Exelixis’ focus on and commitment to maximizing the potential of
the cabozantinib franchise through commercial activities and ongoing
clinical development program evaluating the compound alone, or in
combination with immune checkpoint inhibitors, across multiple tumor
types; the financial terms of Exelixis’ collaboration with Genentech and
eligibility to receive royalties on sales; Exelixis’ commitment to
reinvesting in its business to maximize the potential of its pipeline,
including supplementing its existing therapeutic assets through targeted
business development activities and internal drug discovery; and
Exelixis’ mission to deliver the next generation of Exelixis medicines
and help patients recover stronger and live longer. Words such as
“will,” “plan,” “focused,” “eligible,” “commitment,” “intend,” 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: Exelixis’ dependence on its relationship with
Genentech/Roche with respect to cobimetinib and Exelixis’ ability to
maintain its rights under the collaboration; risks related to the
potential failure of cobimetinib to demonstrate safety and efficacy in
clinical testing; the availability of data at future medical meeting;
market acceptance and the availability of coverage and reimbursement for
COTELLIC; risks and uncertainties related to regulatory review and
approval processes; Exelixis’ ability to conduct clinical trials of its
product candidates sufficient to achieve a positive completion; the
level of costs associated with Exelixis’ commercialization, research and
development and other activities; competition in the area of business
development activities and the inherent uncertainty of the drug
discovery process; Exelixis’ dependence on its relationships with its
cabozantinib collaboration partners, including, the level of their
investment in the resources necessary to successfully commercialize
cabozantinib in the territories where it is approved; Exelixis’
dependence on third-party vendors for the development, manufacture and
supply of its products; Exelixis’ ability to protect the company’s
intellectual property rights; 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 May 2, 2018, 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 and the Exelixis logo are registered U.S. trademarks of
View source version on businesswire.com: https://www.businesswire.com/news/home/20180509006653/en/
Source: Exelixis, Inc.
EVP, Public Affairs and Investor
For Exelixis, Inc.