|[July 14, 2014]
Genentech's Investigational Medicine Cobimetinib, Used in Combination with Zelboraf® (Vemurafenib), Helped People with Advanced Melanoma Live Significantly Longer Without Their Disease Worsening
SOUTH SAN FRANCISCO, Calif. --(Business Wire)--
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the Phase III coBRIM study met its primary
endpoint. The study demonstrated that the investigational MEK inhibitor
cobimetinib, used in combination with Genentech's BRAF inhibitor
Zelboraf, helped patients with previously untreated BRAF V600
mutation-positive advanced melanoma live significantly longer without
their disease worsening (progression-free survival; PFS) compared to
Zelboraf alone. Adverse events were consistent with those observed in a
previous study of the combination.
"Despite great progress in our understanding and therapy in recent
years, advanced melanoma remains a difficult and deadly disease that
requires more treatment options," said Sandra Horning, M.D., chief
medical officer and head of Global Product Development. "These
encouraging data support the potential combined use of cobimetinib with
Zelboraf to block tumor growth longer than Zelboraf alone. We hope this
combination therapy will lead to a new option for patients."
Data from this pivotal study will be presented at an upcoming medical
meeting. Additionally, Genentech plans to submit these data to the FDA
for potential approval.
Cobimetinib is designed to selectively block the activity of MEK, one of
a series of proteins inside cells that make up a signaling pathway that
helps regulate cell division and survival. Cobimetinib binds to MEK
while Zelboraf binds to mutant BRAF, another protein on the pathway, to
interrupt abnormal signaling that can cause tumors to grow.
About the coBRIM Study
CoBRIM is an international, randomized, double-blind, placebo-controlled
Phase III study evaluating the safety and efficacy of cobimetinib in
combination with Zelboraf, compared to Zelboraf alone, in 495 patients
with BRAF V600 mutation-positive unresectable locally advanced or
metastatic melanoma, previously untreated for advanced disease. The
primary endpoint for coBRIM is PFS. Secondary endpoints include overall
survival, objective response rate, duration of response and other
safety, pharmacokinetic and quality of life measures.
The coBRIM study used the Roche cobas® 4800 BRAF Mutation
Test to determine eligibility of patients for the study. This test
identifies people whose tumors carry the BRAF V600 mutation, and
therefore, patients who are most appropriate to receive this combination
Melanoma is less common, but more aggressive and deadlier tan other
forms of skin cancer. BRAF is mutated in approximately half of
melanomas. 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 76,100 new
cases of melanoma and approximately 9,700 melanoma deaths this year in
the United States. In recent years, there have been significant advances
in treatment for metastatic melanoma and people with the disease now
have more options. However, melanoma continues to be a serious health
issue as the incidence has been steadily increasing for the past 30
Cobimetinib (GDC-0973, XL518) was discovered by Exelixis Inc. and is
being developed in collaboration with Exelixis. In addition to the
combination with Zelboraf in melanoma, cobimetinib is also being
investigated in combination with several investigational medicines,
including an immunotherapy, in several tumor types, including non-small
cell lung cancer and colorectal cancer.
Zelboraf is a prescription medicine used 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 has a certain type of abnormal "BRAF" gene. A
patient's healthcare provider will perform a test to make sure that
Zelboraf is right for the patient. Zelboraf is not used to treat
melanoma with a normal BRAF gene. Zelboraf is now approved in more than
80 countries and has been used to treat more than 11,000 patients
Important Safety Information
Zelboraf can cause serious side effects, including risk of cancers.
Zelboraf may cause a type of skin cancer called cutaneous squamous
cell carcinoma (cuSCC). New melanoma lesions have occurred in people who
take Zelboraf. Zelboraf may also cause another type of cancer called
non-cutaneous squamous cell carcinoma (SCC). Patients must talk with
their healthcare provider about their risk for these cancers. Patients
must check their skin and tell their doctor about skin changes including
a new wart, a sore or bump that bleeds or does not heal, or a mole that
changes size or color.
A patient's healthcare provider should also check for cancers that may
not occur on the skin. Patients must tell their healthcare provider
about any new symptoms that they get while taking Zelboraf.
While taking Zelboraf, patients should avoid sunlight. When they go
outside, patients must wear clothes that protect their skin, including
their head, face, hands, arms and legs. Patients must use lip balm and a
broad-spectrum sunscreen with SPF 30 or higher.
Possible serious side effects of Zelboraf include severe allergic
reactions, severe skin reactions, potentially life-threatening changes
in the electrical activity of the heart called QT prolongation, abnormal
liver function tests and eye problems. Patients must tell their doctor
if they are pregnant or plan to become pregnant as Zelboraf can harm a
patient's unborn baby.
Common side effects of Zelboraf include joint pain, rash, hair loss,
tiredness, sunburn or sun sensitivity, nausea, itching or warts.
Patients must tell their doctor if they have any side effect that
bothers them or does not go away. These are not all of the possible side
effects of Zelboraf. For more information about side effects, patients
should ask their doctor or pharmacist.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.
Patients should read the full Prescribing Information and Medication
Guide for additional important safety information at http://www.zelboraf.com.
Founded more than 35 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious or life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
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