-- Avastin Plus Chemotherapy Reduced the Risk
of the Disease Worsening by 62 Percent Compared to Chemotherapy
Alone in a Phase III Study --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced that the U.S. Food and Drug Administration
(FDA) approved Avastin® in combination with chemotherapy for the
treatment of women with platinum-resistant, recurrent ovarian
cancer. The approval was based on results from the Phase III
AURELIA study that showed Avastin plus chemotherapy reduced the
risk of disease worsening or death (progression-free survival or
PFS) by 62 percent compared to women who received chemotherapy
alone (median PFS: 6.8 vs. 3.4 months, Hazard Ratio (HR)=0.38;
p<0.0001). Adverse events were consistent with those seen in
previous trials of Avastin across tumor types for approved
indications, but also included high blood pressure and pain,
redness or swelling of the hands or feet from the Phase III
study.
“Avastin plus chemotherapy is the first new treatment option for
women with this difficult-to-treat type of ovarian cancer in more
than 15 years,” said Sandra Horning, M.D., chief medical officer
and head of Global Product Development. “Risk of the disease
worsening was reduced by 62 percent for women who received Avastin
plus chemotherapy in the study, and a notable treatment effect was
observed with paclitaxel, which may be important when choosing
treatment.”
The new indication of Avastin is in combination with paclitaxel,
pegylated liposomal doxorubicin or topotecan chemotherapy for the
treatment of women with platinum-resistant, recurrent, epithelial
ovarian, fallopian tube, or primary peritoneal cancer, who have
received no more than two prior chemotherapy regimens. With this
approval, Avastin is approved in the United States to treat six
distinct tumor types.
About the AURELIA Study
AURELIA is a company-sponsored, multicenter, randomized,
open-label, Phase III study in 361 women with platinum-resistant,
recurrent, epithelial ovarian, primary peritoneal, or fallopian
tube cancer, who had received no more than two anticancer regimens
prior to enrollment in the trial. Participants were randomized to
one of six treatment arms (paclitaxel, topotecan or pegylated
liposomal doxorubicin with or without Avastin). The primary
endpoint of the study was investigator-assessed PFS. An analysis of
efficacy by chemotherapy type is shown below.
Efficacy Results in the Intent-to-Treat (ITT)
Population Chemotherapy Type All Chemotherapies
(Intent-To-Treat) Study Group Chemotherapy Alone Avastin
+ Chemotherapy
Primary Endpoint - Progression-Free Survival
(PFS)
Median PFS (months)
3.4 6.8
(95% CI) (2.1, 3.8) (5.6, 7.8)
HR (95% CI)
0.38 (0.30, 0.49)
p-value <0.0001
Overall Survival
(OS; Secondary Endpoint) Median OS (months) 13.3 16.6
(95% CI) (11.9, 16.4) (13.7, 19.0)
HR (95% CI) 0.89
(0.69, 1.14)
Overall Response Rate (ORR; Secondary Endpoint)
ORR (%) 13% 28%
(95% CI) (7, 18) (21, 36)
Safety
Profile (Secondary Endpoint) Grade 3-4 adverse events occurring
at a higher incidence (≥ two percent) in women receiving Avastin
plus chemotherapy compared to women receiving chemotherapy alone
were high blood pressure (6.7 percent vs. 1.1 percent) and
hand-foot syndrome (4.5 percent vs. 1.7 percent).
Efficacy
Results in Chemotherapy Cohorts Chemotherapy Type
Paclitaxel (PAC) Topotecan (TOP) Pegylated
Liposomal Doxorubicin (PLD) Study Group PAC Alone
(N=55)
Avastin + PAC
(N=60)
TOP
(N=63)
Avastin + TOP
(N=57)
PLD
(N=64)
Avastin + PLD
(N=62)
Median PFS (months)
3.9 9.6 2.1 6.2 3.5 5.1
(95% CI) (3.5, 5.5)
(7.8, 11.5)
(1.9, 2.3) (5.3, 7.6) (1.9, 3.9) (3.9, 6.3)
HR (95% CI) 0.47
(0.31, 0.72) 0.24 (0.15, 0.38) 0.47 (0.32, 0.71)
Median
OS (months) 13.2 22.4 13.3 13.8 14.1 13.7
(95% CI) (8.2,
19.7) (16.7, 26.7) (10.4, 18.3) (11.0, 18.3) (9.9, 17.8) (11.0,
18.3)
HR (95% CI) 0.64 (0.41, 1.01) 1.12 (0.73, 1.73) 0.94
(0.63, 1.42)
ORR (%) 30% 53% 2% 17% 8% 16%
(95%
CI) (17, 44) (39, 68) (0, 6) (6, 28) (0, 15) (6, 26)
About Ovarian Cancer
Ovarian cancer causes more deaths than any other gynecologic
cancer in the United States. In 2014, nearly 22,000 women will be
diagnosed with ovarian cancer in the United States and more than
14,000 will die from the disease. Patients are said to have
‘platinum-resistant’ disease if the disease worsens within six
months of completing platinum-based chemotherapy. One quarter of
those who relapse after initial treatment, more than 4,300 women,
will have platinum-resistant cancer, the most difficult-to-treat
form of the disease.
About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping
people access the Genentech medicines they are prescribed,
regardless of their ability to pay. The team of 350
in-house specialists at Access Solutions is dedicated to
helping people navigate the access and reimbursement process, and
to providing assistance to eligible patients in the United
States who are uninsured or cannot afford the out-of-pocket
costs for their medicine. To date, the team has helped more
than 1 million patients access the medicines they need. Please
contact Access Solutions (866) 4ACCESS/(866)
422-2377 or visit http://www.Genentech-Access.com for
more information.
About Avastin
Avastin is a prescription-only medicine that is a solution for
intravenous infusion. It is a biologic antibody designed to
specifically bind to a protein called vascular endothelial growth
factor (VEGF) that plays an important role throughout the lifecycle
of the tumor to develop and maintain blood vessels, a process known
as angiogenesis. Avastin is designed to interfere with the tumor
blood supply by directly binding to the VEGF protein to prevent
interactions with receptors on blood vessel cells. The tumor blood
supply is thought to be critical to a tumor's ability to grow and
spread in the body (metastasize).
Avastin U.S. Indications:
Colon Cancer
- Avastin is approved for the first or
second line treatment of patients with metastatic colorectal cancer
in combination with intravenous 5 fluorouracil–based
chemotherapy.
- Avastin in combination with
fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based
chemotherapy is approved for the second line treatment of patients
with metastatic colorectal cancer who have progressed on a first
line Avastin-containing regimen.
- Avastin is not approved for adjuvant
treatment of colon cancer.
Lung Cancer
- Avastin, in combination with
carboplatin and paclitaxel chemotherapy, is approved for first-line
treatment of patients with unresectable, locally advanced,
recurrent or metastatic nonsquamous, non-small cell lung
cancer.
Kidney Cancer
- Avastin is approved for the treatment
of metastatic renal cell carcinoma in combination with interferon
alfa.
Cervical Cancer
- Avastin is approved in combination with
paclitaxel and cisplatin or paclitaxel and topotecan for treatment
of women with persistent, recurrent or metastatic carcinoma of the
cervix.
Ovarian Cancer
- Avastin is approved in combination with
paclitaxel, pegylated liposomal doxorubicin or topotecan for the
treatment of women with platinum-resistant, recurrent, epithelial
ovarian, fallopian tube, or primary peritoneal cancer, who received
no more than two prior chemotherapy regimens.
BOXED WARNINGS and Additional Important Safety
Information
People receiving 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 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 event occurred
in more people who received Avastin than in the comparison group
(up to 3.2 percent).
- In some cases, GI perforation resulted
in fatality. Avastin therapy should be permanently stopped if GI
perforation occurs.
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. In a controlled clinical trial, in patients with
metastatic colorectal cancer who had surgery during the course of
treatment, the incidence of wound healing complications, including
serious and fatal complications, was 15 percent for patients who
received Avastin and four percent for patients who did not receive
Avastin.
- 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 wound healing problems
following surgery has not been determined.
- Treatment with Avastin should be
stopped at least 28 days before voluntary surgery and in people
with wound healing problems following surgery that require medical
treatment. Treatment with Avastin should be stopped in patients
with slow or incomplete wound healing.
Severe bleeding:
- Treatment with Avastin can result in
serious or fatal 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 compared to patients who
received only chemotherapy.
- Across cancer types, 0.4 percent to 6.9
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. Treatment with Avastin should be
permanently stopped if serious bleeding occurs.
Additional serious adverse events:
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 in
the body (GI and non-GI fistula formation) was seen in up to 2% of
people in metastatic colorectal cancer patients, but less commonly
in other cancer types. In a study of patients with cervical cancer,
formation of an abnormal passage between the vagina and GI tract
was seen in 8.3% of people.
- Severe to life-threatening stroke or
heart problems were seen in 2.6 percent of people.
- Too much protein in the urine that led
to kidney problems was seen in ≤1% 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 blood clots
(VTE), up to 10.6%
- Severe to life-threatening high blood
pressure, which was seen in 5% to 18% of people
- Nervous system and vision disturbances
(Posterior Reversible Encephalopathy Syndrome) which was seen in
less than 0.5% of people
- Infusion reactions with the first dose
of Avastin were uncommon and occurred in less than three percent of
people, and severe reactions occurred in 0.2 percent of
people.
- Avastin can cause fertility issues for
women. Avastin could cause a woman’s ovaries to stop working and
may impair her ability to have children.
- Avastin should not be used in ovarian
cancer patients who have evidence of recto-sigmoid involvement by
pelvic examination or bowel involvement on CT scan or clinical
symptoms of bowel obstruction.
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.
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.
Women should be advised to discontinue nursing or discontinue
treatment with Avastin, taking into account the importance of
Avastin to the mother.
Report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch.Patients and
caregivers may also report side effects to Genentech at (888)
835-2555.
For full Prescribing Information and Boxed WARNINGS on Avastin,
please visit http://www.avastin.com.
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.
GenentechMedia Contact:Holli Dickson, 650-467-6800orAdvocacy
Contact:Jo Dulay, 202-423-2743orInvestor Contacts:Eka Kortkhonjia,
650-467-5873Karl Mahler, 011 41 61 687 8503
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