Published: March 11, 2010
Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer
SOUTH SAN FRANCISCO, Calif. - (BUSINESS WIRE) - Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG;
OTCQX: RHHBY), announced today the topline results of a Phase III trial
led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the
National Cancer Institute (NCI) investigating the use of Avastin
(bevacizumab) in combination with docetaxel chemotherapy and prednisone
in men with late stage prostate cancer (hormone-refractory / HRPC). The
study, known as CALGB 90401, did not meet its primary objective of
extending overall survival compared to chemotherapy and prednisone
alone. A preliminary assessment of safety performed by CALGB has shown
adverse events that have been previously observed in pivotal trials with
Avastin. Data from the study will be submitted by CALGB for presentation
at the American Society of Clinical Oncology (ASCO) annual meeting, June
4 to 8, 2010.
"Patients with hormone-refractory prostate cancer are in urgent need of
new treatment options. It is unfortunate that the study did not meet its
primary objective, however, we look forward to sharing the data with the
medical community, including the secondary endpoints," said Hal Barron,
M.D., head, Global Development and chief medical officer at Roche.
These findings do not impact Avastin's approved uses or its broad
development program in other tumor types.
About Prostate Cancer
Among American men, prostate cancer is the most common form of cancer
and the second leading cause of cancer death. According to the American
Cancer Society, in 2009 an estimated 192,000 men were diagnosed with
prostate cancer and approximately 27,000 died from the disease in the
United States.
About CALGB 90401
CALGB 90401 is a multicenter, randomized, double-blinded,
placebo-controlled Phase III study designed to evaluate Avastin plus
docetaxel chemotherapy and prednisone, compared to docetaxel
chemotherapy and prednisone alone in 1,050 men with hormone-refractory
prostate cancer. The trial is sponsored by the NCI under a Cooperative
Research and Development Agreement between the NCI and Genentech, and
conducted by a network of researchers led by the CALGB.
The primary endpoint of the study is overall survival. Secondary
endpoints of the study include progression-free survival,
prostate-specific antigen response rate and safety.
Detailed safety assessments are ongoing. A preliminary assessment of
safety performed by CALGB has identified severe adverse events that have
been previously observed in pivotal trials with Avastin, including
neutropenia and fatal infections.
About Avastin
Avastin is a solution for intravenous infusion and is a biologic
antibody designed to specifically bind to a protein called vascular
endothelial growth factor (VEGF). VEGF plays an important role
throughout the lifecycle of the tumor to develop and maintain blood
vessels, a process known as angiogenesis. Avastin interferes with the
tumor blood supply by directly binding to the VEGF protein to prevent
interactions with receptors on blood vessel cells. Avastin does not bind
to receptors on normal or cancer cells. The tumor blood supply is
thought to be critical to a tumor's ability to grow and spread in the
body (metastasize). For more information about angiogenesis, visit http://www.gene.com.
Boxed WARNINGS and Additional Important Safety Information
People treated with Avastin may experience side effects. In clinical
trials, some people treated with Avastin experienced serious and
sometimes fatal side effects, including:
Gastrointestinal (GI) perforation: Treatment with Avastin can
result in the development of a potentially serious side effect called GI
perforation, which is the development of a hole in the stomach, small
intestine or large intestine. In clinical trials, this side effect
occurred in more people who received Avastin than in the comparison
group (0.3 percent to 2.4 percent). In some cases, GI perforation
resulted in fatality.
Surgery and wound healing problems: Treatment with Avastin can
lead to slow or incomplete wound healing (for example, when a surgical
incision has trouble healing or staying closed). In some cases, this
event resulted in fatality. Surgery and wound healing problems occurred
more often in people who received Avastin than in the comparison group.
Avastin therapy should not be started for at least 28 days after surgery
and until the surgical wound is fully healed. The length of time between
stopping Avastin and having voluntary surgery without the risk of having
surgery and wound healing problems following surgery has not been
determined.
Severe bleeding: Treatment with Avastin can result in serious
bleeding, including coughing up blood, bleeding in the stomach, vomiting
of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These
events occurred up to five times more often in people who received
Avastin. Across cancer types, 1.2 percent to 4.6 percent of people who
received Avastin experienced severe to fatal bleeding. People who have
recently coughed up blood (greater than or equal to a half teaspoon of
red blood) or have serious bleeding should not receive Avastin.
In clinical trials for different cancer types, there were additional
serious and sometimes fatal side effects that occurred in more people
who received Avastin than in those in the comparison group. The
formation of an abnormal passage from parts of the body to another part
(non-GI fistula formation) was seen in 0.3 percent or less of people.
Severe to life-threatening stroke or heart problems were seen in 2.4
percent of people. Too much protein in the urine, which led to kidney
problems, was seen in less than 1 percent of people. Additional serious
side effects that occurred in more people who received Avastin than
those in the comparison group included severe to life-threatening high
blood pressure, which was seen in 5 percent to 18 percent of people, and
nervous system and vision disturbances (reversible posterior
leukoencephalopathy syndrome), which was seen in less than 0.1 percent
of people. Infusion reactions with the first dose of Avastin were
uncommon and occurred in less than 3 percent of people and severe
reactions occurred in 0.2 percent of people.
Common side effects that occurred in more than 10 percent of people who
received Avastin for different cancer types, and at least twice the rate
of the comparison group, were nosebleeds, headache, high blood pressure,
inflammation of the nose, too much protein in the urine, taste change,
dry skin, rectal bleeding, tear production disorder, back pain and
inflammation of the skin (exfoliative dermatitis). Across all trials,
treatment with Avastin was permanently stopped in 8.4 percent to 21
percent of people because of side effects.
Avastin may impair fertility. Patients who are pregnant or thinking of
becoming pregnant should talk with their doctor about the potential risk
of loss of the pregnancy or the potential risk of Avastin to the fetus
during and following Avastin therapy, and the need to continue an
effective birth control method for at least six months following the
last dose of Avastin.
For full Prescribing Information and Boxed WARNINGS on Avastin please
visit http://www.avastin.com.
About Genentech
Founded more than 30 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 wholly owned member of the Roche Group, has
headquarters in South San Francisco, California. For additional
information about the company, please visit http://www.gene.com.
Genentech, Inc.
Media Contact:
Charlotte Arnold, 650-467-6800
Advocacy
Contact:
Kristin Reed, 650-467-9831
Investor Contacts:
Kathee
Littrell, 650-225-1034
Karl Mahler, 011 41 61 687 85 03
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