Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced that the Phase III IMagyn050 study showed
that the addition of Tecentriq® (atezolizumab) to Avastin®
(bevacizumab), paclitaxel and carboplatin did not meet its primary
endpoint of progression-free survival (PFS) for the front-line
treatment of women with newly-diagnosed advanced-stage ovarian
cancer. Topline safety data indicate that safety for Tecentriq in
combination with Avastin, paclitaxel and carboplatin was consistent
with the known safety profile of the combination.
“Ovarian cancer remains one of the most aggressive cancers and
is difficult to treat in its advanced stages,” said Levi Garraway,
M.D., Ph.D., chief medical officer and head of Global Product
Development. “While we are disappointed by these results, we remain
committed to improving outcomes for women living with this disease
and are pleased that Avastin remains a key component in the
treatment of front-line ovarian cancer.”
Data for the overall survival (OS) co-primary endpoint are
currently immature and follow-up will continue until the next
planned analysis. Results from IMagyn050 will be further evaluated
in order to inform the Tecentriq gynecological development program.
The Tecentriq program in ovarian cancer and cervical cancers builds
on the combination with Avastin, which has helped women with newly
diagnosed, advanced or relapsed ovarian and cervical cancers live
without their disease getting worse, as demonstrated in results
across seven pivotal Phase III trials that involved more than 5,000
women.
Genentech has an extensive development program for Tecentriq,
including multiple ongoing and planned Phase III studies across
lung, genitourinary, skin, breast, gastrointestinal, gynecological,
and head and neck cancers. This includes studies evaluating
Tecentriq both alone and in combination with other medicines.
About the IMagyn050 study
IMagyn050 is a Phase III, multicenter, randomized, double-blind
study evaluating the efficacy and safety of Tecentriq in
combination with Avastin, paclitaxel and carboplatin compared to
placebo plus Avastin, paclitaxel and carboplatin in women with
stage III or IV ovarian cancer who are undergoing neoadjuvant or
adjuvant therapy. Patients were randomized 1:1 either before or
after tumor reductive surgery. The co-primary endpoints are
investigator-determined PFS and OS, both in the intent-to-treat
(ITT) population and PD-L1-positive subpopulation. Key secondary
endpoints include objective response rate, safety and tolerability,
as well as patient-reported improvement in abdominal pain and
bloating.
The IMagyn050 study is being conducted in collaboration with The
GOG Foundation, Inc. (GOG Foundation) [GOG-3015] and the European
Network of Gynaecological Oncological Trial groups (ENGOT) [ENGOT
OV-39].
About ovarian cancer
According to the American Cancer Society, ovarian cancer ranks
fifth in cancer deaths among women. This year, an estimated 21,000
women will be diagnosed with ovarian cancer and 14,000 will die
from the disease. Ovarian cancer remains the leading cause of death
from any gynecological malignancy, as the majority of patients are
not diagnosed until they present with already advanced-stage
disease, resulting in a 5-year survival rate of less than 30%.
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a
protein called PD-L1. Tecentriq is designed to bind to PD-L1
expressed on tumor cells and tumor-infiltrating immune cells,
blocking its interactions with both PD-1 and B7.1 receptors. By
inhibiting PD-L1, Tecentriq may enable the re-activation of T
cells. Tecentriq may also affect normal cells.
About Avastin® (bevacizumab)
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 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).
Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)
Tecentriq is a prescription medicine used to treat adults
with:
A type of bladder and urinary tract cancer called urothelial
carcinoma.
Tecentriq may be used in patients with urothelial carcinoma if
their bladder cancer has spread or cannot be removed by surgery,
and if they have any one of the following conditions:
- They are not able to take chemotherapy that contains a medicine
called cisplatin and their cancer tests positive for “PD-L1”
or
- They are not able to take chemotherapy that contains any
platinum regardless of the levels of “PD-L1” status or
- They have tried chemotherapy that contains platinum and it did
not work or is no longer working
The approval of Tecentriq in these patients is based on a study
that measured the amount of time until patients’ disease worsened.
Continued approval for this use may depend on the results of an
ongoing study to confirm benefit.
A type of lung cancer called non-small cell lung cancer
(NSCLC).
Tecentriq may be used alone as the first treatment in
patients with lung cancer if:
- Their cancer has spread or grown and
- Their cancer tests positive for “high PD-L1,” and
- Their tumor does not have an abnormal “EGFR” or “ALK”
gene.
Tecentriq may be used with the medicines bevacizumab,
paclitaxel, and carboplatin as the first treatment in patients with
lung cancer if:
- Their cancer has spread or grown, and
- Is a type called “non-squamous NSCLC.” and
- Their tumor does not have an abnormal “EGFR” or “ALK”
gene.
Tecentriq may be used with the medicines paclitaxel
protein-bound and carboplatin as the first treatment in patients
with lung cancer if:
- Their cancer has spread or grown, and
- Is a type called “non-squamous NSCLC,” and
- Their tumor does not have an abnormal “EGFR” or “ALK”
gene.
Tecentriq may be used alone in patients with lung cancer
if:
- Their cancer has spread or grown and
- They have tried chemotherapy that contains platinum, and it did
not work or is no longer working If a patient’s tumor has an
abnormal EGFR or ALK gene, they should have also tried an
FDA-approved therapy for tumors with these abnormal genes, and it
did not work or is no longer working.
A type of breast cancer called triple-negative breast cancer
(TNBC).
Tecentriq may be used with the medicine paclitaxel
protein-bound in patients with TNBC when their breast
cancer:
- Has spread or cannot be removed by surgery and
- Their cancer tests positive for “PD-L1”
The approval of Tecentriq in these patients is based on a study
that measured the amount of time until patients’ disease worsened.
Continued approval for this use may depend on the results of an
ongoing study to confirm benefit.
A type of lung cancer called small cell lung cancer
(SCLC).
- Tecentriq may be used with the chemotherapy medicines
carboplatin and etoposide as the first treatment in patients with
SCLC when their lung cancer is a type of lung cancer called
“extensive-stage small cell lung cancer,” which means that it has
spread or grown.
A type of liver cancer called hepatocellular carcinoma
(HCC).
- Tecentriq may be used with the medicine bevacizumab when a
patient’s liver cancer:
- has spread or cannot be removed by surgery, and
- the patient has not received other medicines by mouth or
injection through their vein (IV) to treat their cancer.
It is not known if Tecentriq is safe and effective in
children.
Important Safety Information
The most important information about Tecentriq is:
Tecentriq can cause the immune system to attack normal organs
and tissues and can affect the way they work. These problems can
sometimes become serious or life-threatening and can lead to
death.
Patients should call or see their healthcare provider right
away if they get any symptoms of the following problems or these
symptoms get worse.
Tecentriq can cause serious side effects, including:
- Lung problems (pneumonitis)–signs and symptoms of
pneumonitis may include new or worsening cough, shortness of breath
and chest pain
- Liver problems (hepatitis)–signs and symptoms of
hepatitis may include yellowing of the skin or the whites of the
eyes, severe nausea or vomiting, pain on the right side of the
stomach area (abdomen), drowsiness, dark urine (tea-colored),
bleeding or bruising more easily than normal and feeling less
hungry than usual
- Intestinal problems (colitis)–signs and symptoms of
colitis may include diarrhea (loose stools) or more bowel movements
than usual; blood or mucus in stools or dark, tarry, sticky stools;
and severe stomach area (abdomen) pain or tenderness
- Hormone gland problems (especially the thyroid, adrenal
glands, pancreas, and pituitary)–signs and symptoms that the
hormone glands are not working properly may include headaches that
will not go away or unusual headaches, extreme tiredness, weight
gain or weight loss, dizziness or fainting, feeling more hungry or
thirsty than usual, hair loss, changes in mood or behavior (such as
decreased sex drive, irritability, or forgetfulness), feeling cold,
constipation, the voice gets deeper, urinating more often than
usual, nausea or vomiting and stomach area (abdomen) pain
- Problems in other organs–signs and symptoms may include
severe muscle weakness, numbness or tingling in hands or feet,
confusion, blurry vision, double vision, or other vision problems,
changes in mood or behavior, extreme sensitivity to light, neck
stiffness, eye pain or redness, skin blisters or peeling, chest
pain, irregular heartbeat, shortness of breath or swelling of the
ankles
- Severe infections–signs and symptoms of infection may
include fever, cough, flu-like symptoms, pain when urinating and
frequent urination or back pain
- Severe infusion reactions–signs and symptoms of infusion
reactions may include chills or shaking, itching or rash, flushing,
shortness of breath or wheezing, swelling of the face or lips,
dizziness, fever, feeling like passing out and back or neck
pain
Getting medical treatment right away may help keep these
problems from becoming more serious. A healthcare provider may
treat patients with corticosteroid or hormone replacement
medicines. A healthcare provider may delay or completely stop
treatment with Tecentriq if patients have severe side effects.
Before receiving Tecentriq, patients should tell their
healthcare provider about all of their medical conditions,
including if they:
- Have immune system problems (such as Crohn’s disease,
ulcerative colitis, or lupus); have had an organ transplant; have
lung or breathing problems; have liver problems; have a condition
that affects the nervous system (such as myasthenia gravis or
Guillain-Barre syndrome); or are being treated for an
infection
- Are pregnant or plan to become pregnant. Tecentriq can harm an
unborn baby.
- Patients should tell their healthcare provider right away if
they become pregnant or think they may be pregnant during treatment
with Tecentriq.
- Females who are able to become pregnant:
- Should have a healthcare provider do a pregnancy test before
they start treatment with Tecentriq and
- Should use an effective method of birth control during their
treatment and for at least 5 months after the last dose of
Tecentriq
- Are breastfeeding or plan to breastfeed. It is not known if
Tecentriq passes into breast milk. Patients should not breastfeed
during treatment and for at least 5 months after the last dose of
Tecentriq.
Patients should tell their healthcare provider about all the
medicines they take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq when used alone
include:
- Feeling tired or weak
- Nausea
- Cough
- Shortness of breath
- Decreased appetite
The most common side effects of Tecentriq when used in lung
cancer with other anti-cancer medicines include:
- Feeling tired or weak
- Nausea
- Hair loss
- Constipation
- Diarrhea
- Decreased appetite
The most common side effects of Tecentriq when used in TNBC
with paclitaxel protein-bound include:
- Hair loss
- Tingling or numbness in hands and feet
- Feeling tired
- Nausea
- Diarrhea
- Low red blood cells (anemia)
- Constipation
- Cough
- Headache
- Low white blood cells
- Vomiting
- Decreased appetite
The most common side effects of Tecentriq when used in
hepatocellular carcinoma with bevacizumab include:
- High blood pressure
- Feeling tired or weak
- Too much protein in the urine
Tecentriq may cause fertility problems in females, which may
affect their ability to have children. Patients should talk to
their healthcare provider if they have concerns about
fertility.
These are not all the possible side effects of Tecentriq.
Patients should ask their healthcare provider or pharmacist for
more information. Patients should call their doctor for medical
advice about side effects of Tecentriq.
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.
Please visit http://www.Tecentriq.com for the full
Prescribing Information and for additional Important Safety
Information.
Avastin U.S. Indications
Avastin is approved for:
- Metastatic colorectal cancer (mCRC) for first- or
second-line treatment in combination with intravenous
fluorouracil–based chemotherapy. It is also approved to treat mCRC
for second-line treatment, when used with fluoropyrimidine-based
(combined with irinotecan or oxaliplatin) chemotherapy, after
cancer progresses following a first-line treatment that includes
Avastin
- Avastin is not approved for use after surgery was used as the
primary treatment in patients with colon cancer which has not
spread to other parts of the body.
- Advanced nonsquamous non–small cell lung cancer (NSCLC)
in combination with carboplatin and paclitaxel, in people who have
not received chemotherapy for their advanced disease
- Metastatic kidney cancer (mRCC) when used with
interferon alfa
- Glioblastoma (GBM) in adult patients whose cancer has
progressed after prior treatment (recurrent or rGBM)
- Advanced cervical cancer (CC) in combination with
paclitaxel and cisplatin or paclitaxel and topotecan, is approved
to treat persistent, recurrent, or metastatic cancer of the
cervix
- Hepatocellular Carcinoma (HCC) - Avastin, in combination
with atezolizumab, is indicated for the treatment of patients with
unresectable or metastatic hepatocellular carcinoma (HCC) who have
not received prior systemic therapy
- Ovarian cancer (OC) - Avastin, in combination with
carboplatin and paclitaxel, followed by Avastin alone, is used for
the treatment of patients with advanced (Stage III or IV)
epithelial ovarian, fallopian tube, or primary peritoneal cancer
following initial surgery Avastin in combination with paclitaxel,
pegylated liposomal doxorubicin or topotecan, is approved to treat
platinum-resistant recurrent epithelial ovarian, fallopian tube or
primary peritoneal cancer (prOC) in women who received no more than
two prior chemotherapy treatments. Avastin, either in combination
with carboplatin and paclitaxel or with carboplatin and
gemcitabine, followed by Avastin alone, is approved for the
treatment of patients with platinum-sensitive recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer (psOC).
Possible serious side effects
Everyone reacts differently to Avastin therapy. So, it’s
important to know what the side effects are. Although some
people may have a life-threatening side effect, most do not.
Their doctor will stop treatment if any serious side effects occur.
Patients should contact their health care team if there are any
signs of these side effects.
- GI perforation. A hole that develops in the
stomach or intestine. Symptoms include pain in the abdomen, nausea,
vomiting, constipation, or fever
- Abnormal passage in the body. This type of
passage-known as a fistula-is an irregular connection from one part
of the body to another and can sometimes be fatal
- Wounds that don’t heal. A cut made during surgery can be
slow to heal or may not fully heal. Avastin should not be used for
at least 28 days before or after surgery and until surgical wounds
are fully healed
- Serious bleeding. This includes vomiting or coughing up
blood; bleeding in the stomach, brain, or spinal cord; nosebleeds;
and vaginal bleeding. If a patient has recently coughed up blood or
had serious bleeding, they should be sure to tell their doctor
- Severe high blood pressure. Blood pressure that severely
spikes or shows signs of affecting the brain. Blood pressure should
be monitored every 2 to 3 weeks while on Avastin and after stopping
treatment
- Kidney problems. These may be caused by too much protein
in the urine and can sometimes be fatal
- Infusion-related reactions. These were uncommon with the
first dose (less than 3% of patients). 0.2% of patients had severe
reactions. Infusion reactions include high blood pressure or severe
high blood pressure that may lead to stroke, trouble breathing,
decreased oxygen in red blood cells, a serious allergic reaction,
chest pain, headache, tremors, and excessive sweating. The
patient’s doctor or nurse will monitor for signs of infusion
reactions
- Severe stroke or heart problems. These may include blood
clots, mini-stroke, heart attack, chest pain, and the heart may
become too weak to pump blood to other parts of the body
(congestive heart failure). These can sometimes be fatal
- Nervous system and vision problems. Signs include
headache, seizure, high blood pressure, sluggishness, confusion,
and blindness
Side effects seen most often
In clinical studies across different types of cancer, some
patients experienced the following side effects:
- High blood pressure
- Too much protein in the urine
- Nosebleeds
- Rectal bleeding
- Back pain
- Headache
- Taste change
- Dry skin
- Inflammation of the skin
- Inflammation of the nose
- Watery eyes
Avastin is not for everyone
Patients should talk to their doctor if they are:
- Undergoing surgery. Avastin should not be used for 28
days before or after surgery and until surgical wounds are fully
healed
- Pregnant or think they are pregnant. Data have shown
that Avastin may harm a woman’s unborn baby. Birth control should
be used while patients are on Avastin. If Avastin is stopped,
patients should keep using birth control for 6 months before trying
to become pregnant
- Planning to become pregnant. Taking Avastin could cause
a woman’s ovaries to stop working and may impair her ability to
have children
- Breastfeeding. Breastfeeding while on Avastin may harm
the baby, therefore women should not breastfeed during and for 6
months after taking Avastin
Patients should talk with their doctor if they have any
questions about their condition or treatment.
Report side effects to the FDA at 1-800-FDA-1088 or
http://www.fda.gov/medwatch. Report side effects to Genentech at
1-888-835-2555.
For full Prescribing Information and Boxed WARNINGS on
Avastin please visit http://www.avastin.com.
About Genentech in cancer immunotherapy
Genentech has been developing medicines to redefine treatment in
oncology for more than 35 years, and today, realizing the full
potential of cancer immunotherapy is a major area of focus. With
more than 20 immunotherapy molecules in development, Genentech is
investigating the potential benefits of immunotherapy alone, and in
combination with various chemotherapies, targeted therapies and
other immunotherapies with the goal of providing each person with a
treatment tailored to harness their own unique immune system.
In addition to Genentech’s approved PD-L1 checkpoint inhibitor,
the company’s broad cancer immunotherapy pipeline includes other
checkpoint inhibitors, individualized neoantigen therapies and T
cell bispecific antibodies. For more information visit
http://www.gene.com/cancer-immunotherapy.
About Genentech
Founded more than 40 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious and
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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