– Study did not meet its primary endpoint of
improving overall survival versus regorafenib –
– Results will be submitted for presentation
at an upcoming medical meeting –
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 regimens.
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 Indication
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 surgery, and
- 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 baby.
- 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 COTELLIC.
- 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 medicine.
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 higher.
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 carcinoma).Patients
should check their skin regularly and tell their healthcare
provider right away if they have any skin changes including:
- new wart
- 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.Patients 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
- headaches
- 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
- tiredness
- 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
- blisters
- peeling skin
- Eye problems. Patients should
tell their healthcare provider right away if they get any of these
symptoms:
- blurred vision
- partly missing vision or loss of
vision
- see halos
- 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
- sun rash
- skin irritation
- 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:
- diarrhea
- nausea
- fever
- vomiting
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.
About Exelixis
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 Exelixis, Inc.
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Investors Contact:Exelixis, Inc.Susan Hubbard,
650-837-8194EVP, Public Affairs and Investor
Relationsshubbard@exelixis.comorMedia Contact:For Exelixis,
Inc.Hal Mackins, 415-994-0040hal@torchcommunications.com
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