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– Median overall survival of 13 months in patients with microsatellite-stable (MSS) disease –
– Durable responses observed in heavily pretreated patient population –
– Top-line results for IMblaze370, the phase 3 pivotal trial of the cobimetinib-atezolizumab combination in MSS colorectal cancer are anticipated in 1H 2018 –
“The results of this study suggest the combination of cobimetinib and
atezolizumab continues to be associated with encouraging tolerability
and clinical activity in patients with metastatic colorectal cancer,”
The ongoing phase 1b trial (NCT01988896) evaluates the combination of cobimetinib and atezolizumab in a variety of solid tumors. Following the selection of a recommended dose in the trial’s dose escalation stage, expansion cohorts in metastatic CRC, non-small cell lung cancer, and melanoma began enrolling. The trial’s primary endpoints are the evaluation of the safety and tolerability of the combination. Secondary endpoints include investigator-assessed objective response rate (ORR), progression-free survival (PFS) by RECIST 1.1, and overall survival (OS).
As of the
Preliminary Clinical Activity. Across all
Investigators also conducted a best overall response (BOR) analysis across all patients, although seven patients had missing or unevaluable BOR data. The ORR was eight percent (n=7). Of the seven confirmed Partial Responses (PRs), four were in patients with MSS tumors, and one was in a patient with MSI-low tumors. The remaining two PRs were in patients whose tumor MSI status was unknown. The Disease Control Rate (PR + Stable Disease [SD]) was 31 percent, comprised of the 7 PRs (8%) and 19 instances (23%) of SD. The median duration of response was 14.3 months.
Safety. Investigators reported the majority of adverse events (AEs) were manageable. There were no treatment-related grade 5 AEs, and the incidence of treatment-related grade 3 and 4 AEs was 38 percent (n=32). Rash, diarrhea, fatigue, and increased blood creatine phosphokinase were the most frequent treatment-related grade 3-4 AEs reported (five percent each).
About the IMblaze370 Phase 3 Pivotal Trial
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®.
TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib)
and ZELBORAF® (vemurafenib) are registered trademarks of
Genentech, a member of the
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. 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 misses a dose of COTELLIC® or vomits after taking their dose, 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
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 weaknes
- 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:
- sunburn or sun sensitivity
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)
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®.
Patients should call their doctor for medical advice about side effects.
Patients may report side effects to
Founded in 1994,
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements, including,
without limitation, statements related to: the clinical and therapeutic
potential of the combination of cobimetinib and atezolizumab for
patients with metastatic CRC; the expected timing for top-line results
from IMblaze370 in the first half of 2018; 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 “could,” “expects,” “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; risks and
uncertainties related to regulatory review and approval processes; the
availability of data at the referenced time; market acceptance and the
availability of coverage and reimbursement for COTELLIC; 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
Susan Hubbard, 650-837-8194
EVP, Public Affairs and Investor Relations
Lindsay Treadway, 650-837-7522
Director, Public Affairs and Advocacy Relations