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– Study did not meet its primary endpoint of improving overall survival versus regorafenib –
– Results will be submitted for presentation at an upcoming medical meeting –
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
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
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
Under the terms of the collaboration,
Cobimetinib is now approved in multiple countries, including the U.S.,
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
- 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
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
- 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
- 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:
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
TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib)
and ZELBORAF® (vemurafenib) are registered trademarks of
Genentech, a member of the
Founded in 1994,
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
Susan Hubbard, 650-837-8194
EVP, Public Affairs and Investor Relations
For Exelixis, Inc.
Hal Mackins, 415-994-0040