-- Phase III coBRIM study demonstrated a median
progression-free survival of 12.3 months with cobimetinib plus
Zelboraf --
-- Additional data from Phase Ib BRIM7 study
showed 61 percent of people who had not been previously treated
with a BRAF inhibitor were alive after two years --
-- The FDA is expected to make a decision on
Genentech’s new drug application for cobimetinib in combination
with Zelboraf by August 11, 2015 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced follow-up data from two studies of the
investigational MEK inhibitor cobimetinib in combination with
Zelboraf® (vemurafenib). Updated data from the pivotal coBRIM Phase
III study showed the combination helped people with previously
untreated BRAF V600 mutation-positive advanced melanoma live a
median of one year (12.3 months) without their disease worsening or
death (progression-free survival; PFS) compared to 7.2 months with
Zelboraf alone (hazard ratio [HR]=0.58, 95 percent confidence
interval [CI] 0.46-0.72).
“The combination of cobimetinib and Zelboraf extended the time
people lived without their disease getting worse to a year,” said
Sandra Horning, M.D., chief medical officer and head of Global
Product Development. “These results are exciting because they
underscore the importance of combining medicines that target the
signals, which cause about half of all melanomas to grow."
The updated results from coBRIM also demonstrated higher
response rates with cobimetinib and Zelboraf compared to Zelboraf
alone. The objective response rate (ORR) with the combination was
70 percent (16 percent complete response [CR], 54 percent partial
response [PR]) compared to 50 percent (11 percent CR, 40 percent
PR) in the Zelboraf arm. With further follow-up, the complete
response rate increased from 10 percent to 16 percent with the
combination as some patients who had a partial response achieved a
complete response after more than one year of treatment. The safety
profile of cobimetinib and Zelboraf was consistent with safety data
previously reported. The most common adverse events in the
combination arm were diarrhea, rash, nausea, fever, sun
sensitivity, liver lab abnormalities, elevated creatine
phosphokinase (CPK, an enzyme released by muscles) and
vomiting.
Follow-up data from the Phase Ib BRIM7 study showed cobimetinib
plus Zelboraf helped people who had not been previously treated
with a BRAF inhibitor live a median of more than two years (28.5
months). In addition, extended follow-up showed 61 percent of
patients who had not been previously treated with a BRAF inhibitor
were alive after two years. The safety profile was consistent with
the previous analyses. The incidence of serous retinopathy,
cardiomyopathy and cutaneous squamous cell carcinoma were similar
to those previously reported.
The coBRIM and BRIM7 data will be presented during the 51st
Annual Meeting of the American Society of Clinical Oncology (ASCO)
meeting in Chicago held from May 29 – June 2. CoBRIM data will be
presented in an oral session presentation today by Dr. James
Larkin, FRCP, The Royal Marsden Hospital, London, UK (Abstract
#9006, May 30, 3:15-3:27 P.M. CDT). The BRIM7 data will be
presented in a poster presentation by Dr. Anna Pavlick, New York
University Medical Center (Abstract #9020, June 1, 1:15-4:45 P.M.
CDT).
The cobimetinib new drug application for BRAF V600
mutation-positive advanced melanoma was granted priority review by
the U.S. Food and Drug Administration, and a decision is expected
by August 11, 2015. The European Medicines Agency is expected to
make a decision on Roche’s marketing authorization application for
cobimetinib before the end of 2015.
About the coBRIM study
CoBRIM is an international, randomized, double-blind,
placebo-controlled Phase III study evaluating the safety and
efficacy of 60 mg once daily of cobimetinib in combination with 960
mg twice daily of Zelboraf, compared to 960 mg twice daily of
Zelboraf alone. In the study, 495 patients with BRAF V600
mutation-positive unresectable locally advanced or metastatic
melanoma (detected by the cobas® 4800 BRAF Mutation Test) and
previously untreated for advanced disease were randomized to
receive Zelboraf every day on a 28-day cycle plus either
cobimetinib or placebo on days 1-21. Treatment was continued until
disease progression, unacceptable toxicity or withdrawal of
consent. Investigator-assessed PFS is the primary endpoint.
Secondary endpoints include PFS by independent review committee,
overall response rate, overall survival, duration of response and
other safety, pharmacokinetic and quality of life measures.
The most common adverse events reported in patients taking
cobimetinib in combination with Zelboraf (occurring in more than 20
percent) were diarrhea, rash, nausea, fever, sun sensitivity, liver
lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme
released by muscles) and vomiting. Serous retinopathy (collection
of fluid under the retina) was observed at a higher frequency in
the combination arm (26 vs. 3 percent) with most of these events
either Grade 1 or 2, asymptomatic, and temporary in nature. Some
adverse events, including cutaneous squamous cell carcinomas and
keratoacanthomas, were reported less frequently in the combination
arm.
About the BRIM7 study
BRIM7 is a Phase Ib study of 129 patients evaluating the safety
and tolerability of cobimetinib in combination with Zelboraf in
people with BRAF V600 mutation-positive unresectable or metastatic
melanoma who had either not been previously treated with a BRAF
inhibitor or had shown disease progression following treatment with
a BRAF inhibitor. The primary endpoint of the BRIM7 study focused
on safety, tolerability, and the identification of an optimal dose.
The secondary outcome measures focused on efficacy. Patients in the
dose-escalation stage of the study received cobimetinib 60, 80 or
100 mg once daily given on a schedule of 14 days on/14 days off; 21
days on/7 days off; or continuously for 28 days, and Zelboraf 720
or 960 mg twice daily continuously. Following the dose-escalation
stage, two dose levels were selected for further investigation:
cobimetinib 60 mg once daily for 21 days on/7 days off and Zelboraf
(720 mg or 960 mg twice daily).
The most common adverse events were mild to moderate in
severity, and the overall frequency of adverse events with an
extended median follow-up of up to 21 months have remained
consistent without new safety signals.
About the cobimetinib and Zelboraf combination
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 cobimetinib
Cobimetinib (GDC-0973, XL518) was discovered by Exelixis Inc.
and is being developed in collaboration with Exelixis. Cobimetinib
is also being investigated in combination with several
investigational medicines, including an immunotherapy, in several
tumor types such as non-small cell lung cancer and colorectal
cancer.
About Zelboraf
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. BRAF is mutated in approximately half of melanomas. 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. It is not known if Zelboraf is
safe and effective in children under 18 years of age.
Zelboraf is now approved in more than 90 countries and has been
used to treat more than 11,000 patients worldwide. Zelboraf was
co-developed under a 2006 license and collaboration agreement
between Roche and Plexxikon, now a member of the Daiichi Sankyo
Group.
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, liver injury 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.
About 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 nearly 74,000 new cases of melanoma and almost 10,000
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 have
more options. However, it continues to be a serious health issue
with a high unmet need and a steadily increasing incidence over the
past 30 years.
About Genentech in skin cancer
Genentech has been studying new treatments for skin cancer for
nearly 20 years. In the last five years, we have brought two new
medicines to people with potentially disfiguring or deadly skin
cancers. Genentech is continuing to study our skin cancer medicines
as monotherapies and in combination with other investigational
medicines, such as cancer immunotherapies, in several cancer types
and diseases.
About Genentech
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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version on businesswire.com: http://www.businesswire.com/news/home/20150530005023/en/
GenentechMedia Contact:Emmy Wang, 650-467-6800Advocacy
Contact:Jo Dulay, 202-423-2743Investor Contacts:Stefan Foser,
650-467-2016Karl Mahler, 011 41 61 687 8503
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