Exelixis, Inc. (Nasdaq: EXEL) today announced positive results
from IMspire150, the phase 3 trial of atezolizumab (TECENTRIQ®),
cobimetinib (COTELLIC®) and vemurafenib (ZELBORAF®) in people with
previously untreated BRAF V600 mutation-positive advanced melanoma.
Genentech, Inc. (a member of the Roche Group), Exelixis’
collaborator and the sponsor of the IMspire150 trial, informed the
company that the study met its primary endpoint of progression-free
survival (PFS). Adding atezolizumab to cobimetinib and vemurafenib
helped to reduce the risk of disease worsening or death, compared
to placebo plus cobimetinib and vemurafenib.
A significant and clinically meaningful improvement in PFS was
demonstrated in IMspire150. The safety profile observed in the
trial was consistent with the known safety profiles of the
individual medicines. Results will be presented at an upcoming
medical meeting and discussed with health authorities around the
world, including the U.S. Food and Drug Administration and the
European Medicines Agency.
About Advanced Melanoma
Melanoma is less common, but more aggressive and deadlier than
other forms of skin cancer. When melanoma is diagnosed early, it is
generally a curable disease, but most people with advanced melanoma
have a poor prognosis. The American Cancer Society estimates there
will be more than 96,000 new cases of melanoma and 7,000 melanoma
deaths this year in the United States.
In recent years, there have been significant advances in
treatment for advanced melanoma and people with the disease have
more options. However, it continues to be a serious health issue
with a high medical need and a steadily increasing incidence over
the past 30 years.
About the IMspire150 study
IMspire150 is a phase 3, multi-center, double-blind,
placebo-controlled randomized study in people with previously
untreated BRAF V600 mutation-positive metastatic or unresectable
locally advanced melanoma. The study compared the efficacy and
safety of atezolizumab plus cobimetinib and vemurafenib to the
combination of placebo plus cobimetinib and vemurafenib. The
primary endpoint of the study was investigator-assessed PFS. Key
secondary endpoints include PFS by an independent review committee,
overall survival, objective response rate, duration of response and
other safety and pharmacokinetic measures.
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 also the subject of a clinical development
program aimed at evaluating its potential in combination with
investigational and approved therapies in multiple disease
settings.
TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF®
(vemurafenib) are registered trademarks of Genentech, a member of
the Roche Group.
COTELLIC Indication
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 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. Patients should take their next
dose as scheduled.
- 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 change
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.
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 system genetics, 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. Our discovery efforts have resulted in four commercially
available products, CABOMETYX® (cabozantinib), COMETRIQ®
(cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO®
(esaxerenone), and we have entered into partnerships with leading
pharmaceutical companies to bring these important medicines to
patients worldwide. Supported by revenues from our marketed
products and collaborations, we are committed to prudently
reinvesting in our business to maximize the potential of our
pipeline. We are supplementing 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 is a member of Standard & Poor’s (S&P) MidCap 400
index, which measures the performance of profitable mid-sized
companies. For more information about Exelixis, please visit
www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis,
Inc. on Facebook.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Genentech’s
plans to present the IMspire150 data at an upcoming medical meeting
and discuss the data with health authorities around the world,
including the U.S. Food and Drug Administration and European
Medicines Agency; and Exelixis’ plans to reinvest in its business
to maximize the potential of the company’s pipeline, including
through targeted business development activities and internal drug
discovery. Any statements that refer to expectations, projections
or other characterizations of future events or circumstances are
forward-looking statements and 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 referenced times;
risks and uncertainties related regulatory review and approval
processes and Daiichi Sankyo’s compliance with applicable legal and
regulatory requirements; uncertainties inherent in the product
development process; the degree of market acceptance of treatment
combinations with COTELLIC in the territories where they are
approved, and Genentech’s ability to obtain or maintain coverage
and reimbursement for this product; Exelixis’ dependence on its
relationship with Genentech, including Genentech’s investment in
the resources necessary to successfully commercialize treatment
combinations with COTELLIC in the territories where they are
approved; risks and uncertainties related to regulatory review and
approval processes; Exelixis’ and Genentech’s continuing compliance
with applicable legal and regulatory requirements; unexpected
concerns that may arise as a result of the occurrence of adverse
safety events or additional data analyses of clinical trials
evaluating cobimetinib or other compounds with which it may be
combined; Exelixis’ dependence on third-party vendors for the
manufacture and supply of cobimetinib; market competition,
including the potential for competitors to obtain approval for
generic versions of COTELLIC; Exelixis’ and Genentech’s ability to
protect their respective intellectual property rights; changes in
economic and business conditions; and other factors affecting
Exelixis and its partnerships discussed under the caption “Risk
Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on October 30, 2019, and
in Exelixis’ future filings with the SEC. All forward-looking
statements in this press release are based on information available
to Exelixis as of the date of this press release, and Exelixis
undertakes no obligation to update or revise any forward-looking
statements contained herein.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a
registered Japanese trademark.
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version on businesswire.com: https://www.businesswire.com/news/home/20191212005923/en/
Investors Contact: Susan Hubbard Executive Vice
President, Public Affairs & Investor Relations 650-837-8194
shubbard@exelixis.com
Media Contact: Hal Mackins For Exelixis, Inc.
415-994-0040 hal@torchcommunications.com
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