Published: June 06, 2010
Phase III Study Showed Avastin-Based Regimen Helped Women with Advanced Ovarian Cancer Live Longer Without Their Disease Worsening
CHICAGO - (BUSINESS WIRE) - Genentech, Inc., a wholly owned member of the Roche Group, (SIX: RO,
ROG; OTCQX: RHHBY) today announced results from a Phase III study of
Avastin (bevacizumab) that showed women with previously untreated
advanced ovarian cancer who received Avastin in combination with
chemotherapy, followed by the continuation of Avastin alone, had a 39
percent improvement in the likelihood of living longer without the
disease worsening (progression-free survival or PFS) compared to
chemotherapy alone. An assessment of safety noted adverse events
consistent with those observed in pivotal trials of Avastin. The study
(known as GOG 0218), was conducted by a network of researchers led by
the Gynecologic Oncology Group (GOG).
These results were featured in a press briefing today at the 46th Annual
Meeting of the American Society of Clinical Oncology. Full results will
be presented at the ASCO plenary session by Dr. Robert Burger, M.D., the
GOG 0218 Study Chair and Director of the Women's Cancer Center at Fox
Chase Cancer Center (Abstract LBA001, Sunday June 6, 1:45 p.m. CDT).
"Ovarian cancer is a difficult-to-treat disease with high morbidity and
mortality, and there have been limited advances in treatment in the past
decade," said Dr. Burger. "These results may represent an important step
forward for women who need more options."
GOG 0218 demonstrated that women with advanced ovarian cancer who
received front-line (first-line following surgery) Avastin in
combination with chemotherapy (paclitaxel and carboplatin), and
continued use of Avastin alone for a total duration of up to 15 months,
had a median PFS of 14.1 months compared to 10.3 months in women who
received chemotherapy alone (hazard ratio=0.72, p=<0.0001, a 28 percent
reduction in the risk of cancer progression or death, which corresponds
to a 39 percent improvement in the likelihood of living longer without
the disease worsening). The study also investigated Avastin in
combination with chemotherapy but without the continuation of Avastin
alone. Women who received this shorter duration of Avastin did not have
a statistically significant increase in PFS compared with chemotherapy
alone.
"We are encouraged by these results as there have been few improvements
in outcomes for women with this disease in the past decade. Avastin in
combination with chemotherapy, followed by the continued use of Avastin,
helped women with advanced ovarian cancer live longer without their
disease worsening," said Hal Barron, M.D., executive vice president,
Global Development and chief medical officer. "We will discuss these
data and next steps with U.S. and global regulatory authorities."
Adverse events (observed between cycle two and 30 days after last
treatment) that occurred at a higher frequency in patients who received
Avastin in combination with chemotherapy, followed by the continuation
of Avastin alone, compared to patients who received chemotherapy alone,
were neutropenia (low white blood cell count; Grade 4 or higher; 63.3
percent vs. 57.7 percent), pain (Grade 3 or higher; 13.7 percent vs. 9.2
percent) and hypertension (high blood pressure; Grade 3 or higher; 10.4
percent vs. 1.7 percent). Gastrointestinal (GI) events (Grade 2 or
higher) including perforation (a hole in the stomach, small intestine,
or large intestine), fistula (an abnormal passage from one part of the
body to another), necrosis (bowel tissue dying) and leak occurred in 2.6
percent vs. 1.2 percent.
Additional efficacy analysis
The GOG 0218 study protocol allowed for different ways to determine if a
patient's disease had progressed (worsened). Disease progression could
be measured based exclusively on levels of a protein (CA-125) in the
blood, or through the use of CA-125 levels and evidence of progression
by a radiograph/scan. (CA-125 is measured by a blood test and is
sometimes used to demonstrate a response to chemotherapy or to diagnose
a recurrence or progression of ovarian cancer.)
An analysis of efficacy was conducted for regulatory purposes that only
included disease progressions determined by radiographs/scans (excluding
progressions based on CA-125 alone). In this analysis, women who
continued Avastin, following Avastin in combination with chemotherapy,
had a median PFS of 18.0 months compared to 12.0 months in women who
received chemotherapy alone, increasing the likelihood of them living
longer without the disease worsening by 54 percent (based on a hazard
ratio=0.65, p=<0.0001, which corresponds to a 35 percent reduction in
the risk of cancer progression or death).
About the GOG 0218 Study
GOG 0218 is an international, multi-center, randomized, double-blind,
placebo-controlled Phase III study in 1,873 women with previously
untreated advanced epithelial ovarian, primary peritoneal or fallopian
tube carcinoma who already had surgery to remove as much of the tumor as
possible. Patients were randomized to receive one of the following:
-
Arm 1: Placebo (5 cycles1) in combination with carboplatin
(AUC 6 IV) and paclitaxel (175mg/m2) chemotherapy (6
cycles) followed by placebo alone, for a total of up to 15 months.
-
Arm 2: Avastin (5 cycles) in combination with carboplatin (AUC 6 IV)
and paclitaxel (175mg/m2) chemotherapy (6 cycles) followed
by placebo alone, for a total of up to 15 months.
-
Arm 3: Avastin (5 cycles) in combination with carboplatin (AUC 6 IV)
and paclitaxel (175mg/m2) chemotherapy (6 cycles) followed
by the continuation of Avastin alone, for a total of up to 15 months.
The primary endpoint of the study was PFS as assessed by trial
investigators. Secondary and exploratory endpoints of the study included
overall survival, PFS by independent review, safety, quality of life
measures and analysis of patient tumor and blood samples.
About Ovarian Cancer
According to the American Cancer Society, ovarian cancer is the fifth
leading cause of cancer death among American women. In 2009 an estimated
21,500 women were diagnosed with ovarian cancer and approximately 14,500
died from the disease in the United States. The disease causes more
deaths than any other gynecologic cancer, and the American Cancer
Society estimates that nearly 70 percent of women with advanced disease
will die from it within five years.
Ovarian cancer is associated with high levels of vascular endothelial
growth factor (VEGF), a protein associated with tumor growth and spread.
Studies have shown a correlation between a high level of VEGF and a
poorer prognosis in women with ovarian cancer. Currently, treatment
options for women with this disease are limited to surgery and
chemotherapy.
About Avastin
Avastin is a solution for intravenous infusion and is a biologic
antibody designed to specifically bind to a protein called 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.
About The Gynecologic Oncology Group (GOG)
The Gynecologic Oncology Group is a non-profit organization of more than
300 member institutions with the purpose of promoting excellence in the
quality and integrity of clinical and basic scientific research in the
field of Gynecologic malignancies. The Group is committed to maintaining
the highest standards in the clinical trial development, execution,
analysis and distribution of results. Continuous evaluation of the GOG's
processes is utilized in order to constantly improve the quality of
patient care.
GOG receives support from the National Cancer Institute (NCI) of the
National Institutes for Health (NIH).
1 One cycle = 3 weeks
Genentech, Inc.
Krysta Pellegrino, 650-467-6800 (Media)
Kristin
Reed, 650-467-9831 (Advocacy)
Susan Morris, 650-225-6523 (Investors)
Karl
Mahler, 011 41 61 687 85 03 (Investors)
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