Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that new data on nine approved and 18 investigational
medicines will be presented during the 50th American Society of Clinical
Oncology (ASCO) Annual Meeting. Of the more than 320 abstracts on
Genentech medicines, more than 40 have been accepted for oral
presentation.
“Since the first ASCO Annual Meeting 50 years ago, we are proud to have
contributed practice-changing advances for people with a broad range of
tumors including breast, blood, colorectal, lung, and skin cancers,”
said Sandra Horning M.D., chief medical officer and head of Global
Product Development. “Data from nine approved and 18 investigational
medicines, such as our anti-PDL1 immunotherapy, at ASCO this year
demonstrate our continued commitment to improve outcomes for people with
cancer.”
The data to be presented at ASCO show the depth and strength of
Genentech’s oncology pipeline and include the following highlights:
Cancer Immunotherapy: A Phase I study of anti-PDL1 in advanced
bladder cancer will be presented in an oral session on Saturday, May 31.
The presentation will feature important updates including: overall
response rate, biomarker data and safety information. As part of
Genentech’s global development plan to explore the potential of multiple
immunotherapy targets in oncology, anti-PDL1 represents the company’s
most advanced investigational cancer immunotherapy in development.
Hematology: In addition to data from the anti-CD20 medicines
Rituxan® (rituximab) and GazyvaTM (obinutuzumab),
new data from two investigational medicines will be presented for the
first time at ASCO. These data include interim results of a Phase Ib
study of the BCL-2 inhibitor GDC-0199/ABT-199 in combination with
Rituxan in patients with relapsed/refractory chronic lymphocytic
leukemia and results of a Phase II study of polatuzumab vedotin, an
anti-CD79b antibody-drug conjugate, in relapsed/refractory non-Hodgkin’s
lymphoma.
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Overview of key presentations featuring Genentech medicines:
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Medicine
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Description of study
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Abstract number
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MPDL3280A (anti-PDL1) (investigational)
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Inhibition of PD-L1 by MPDL3280A in patients with metastatic
urothelial bladder cancer.
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Abstract #5011
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Avastin® (bevacizumab)
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CALGB/SWOG 80405: Findings from a Phase III study comparing
chemotherapy in combination with bevacizumab or cetuximab - in
first-line treatment of metastatic colorectal cancer without KRAS
mutations.
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Abstract #LBA3
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Avastin +Tarceva®
(erlotinib) (investigational)
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Erlotinib plus bevacizumab versus erlotinib alone as first-line
treatment for advanced EGFR mutation-positive non-squamous
non-small cell lung cancer (NSCLC): An open-label randomized trial.
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Abstract #8005
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Erivedge® (vismodegib)
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Long-term safety profile and efficacy of vismodegib in patients with
advanced basal cell carcinoma: Final update (30-month) of the
pivotal ERIVANCE BCC study.
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Abstract #9013
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GDC-0199/ABT-199 (investigational)
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GDC-0199/ABT-199 combined with rituximab in patients with
relapsed/refractory chronic lymphocytic leukemia: Interim results
of a Phase Ib study.
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Abstract #7013
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Polatuzumab vedotin (anti-CD79b antibody-drug conjugate) and
pinatuzumab vedotin (anti-CD22 antibody-drug conjugate)
(investigational)
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Preliminary results of a Phase II randomized study (ROMULUS) of
polatuzumab vedotin or pinatuzumab vedotin plus rituximab in
patients with relapsed/refractory non-Hodgkin’s lymphoma.
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Abstract #8519
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Zelboraf (investigational)
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VE-BASKET, a first-in-kind, Phase II, histology-independent “basket”
study of vemurafenib in non-melanoma solid tumors harboring BRAF
V600 mutations.
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Abstract #2533
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Zelboraf + cobimetinib (investigational)
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Metabolic tumor burden for prediction of overall survival following
combined BRAF/MEK inhibition in patients with advanced BRAF mutant
melanoma.
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Abstract #9006
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2014 marks the 50-year anniversary of ASCO. Since the first ASCO Annual
Meeting in 1964, Roche and Genentech medicines have been discussed in
thousands of data presentations, including eight plenary presentations
since 2010, representing a significant contribution for people with many
forms of cancer.
Visit http://www.gene.com/asco
for perspectives from Genentech executives on topics of interest at
ASCO, including immunotherapy, lung cancer and quality of care.
About Avastin
Indication
Avastin is approved for first- and second-line treatment of metastatic
colorectal cancer in combination with intravenous 5-FU-based
chemotherapy. Avastin, in combination with fluropyrimidine-irinotecan or
fluoropyrimidine-oxaliplatin based chemotherapy, is indicated for the
second-line treatment of patients with metastatic colorectal cancer who
have progressed on a first-line Avastin-containing regimen. Avastin is
not indicated for adjuvant treatment of colon cancer.
Avastin is approved for first-line treatment of unresectable, locally
advanced, recurrent or metastatic, non-squamous, non-small cell lung
cancer in combination with carboplatin and paclitaxel.
Important Safety Information
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
2.4 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, 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.
Treatment with Avastin should be permanently stopped if serious bleeding
occurs.
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 2.6
percent of people. Too much protein in the urine that led to kidney
problems was seen in less than one 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 five 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 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.
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.
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 Erivedge
Indication
Erivedge capsule is a prescription medicine used to treat
adults with a type of skin cancer, called basal cell carcinoma, that has
spread to other parts of the body or that has come back after surgery or
that their healthcare provider decides cannot be treated with surgery or
radiation.
It is not known if Erivedge is safe and effective in children.
Important Safety Information
Erivedge can cause a baby to die before it is born (be stillborn) or
cause a baby to have severe birth defects.
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For females who can become pregnant, they must talk with their
healthcare provider about the risks of Erivedge to their unborn child.
Their healthcare provider should do a pregnancy test within seven days
before the patient starts taking Erivedge to find out if the patient
is pregnant. Patients must avoid pregnancy by using highly effective
birth control before starting Erivedge, and continue during treatment
and for seven months after their last dose. Patients must tell their
healthcare provider right away if they have unprotected sex or think
that their birth control has failed.
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For males, they must always use a condom with a spermicide during sex
with female partners while they are taking Erivedge and for two months
after their last dose, even if they have had a vasectomy.
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Patients must tell their healthcare provider right away if they or
their female partner could be pregnant or thinks she is pregnant while
they are taking Erivedge.
Exposure to Erivedge during pregnancy:
Pregnant women are encouraged to participate in a program that collects
information about exposure and the effects on the mother and her unborn
child by calling the Genentech Adverse Event Line at (888) 835-2555.
Patients must tell their healthcare provider before taking Erivedge if
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they are pregnant or plan to become pregnant
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if they are breastfeeding or plan to breastfeed
Patients must not donate blood or blood products while they are taking
Erivedge and for seven months after their last dose.
The most common side effects of Erivedge are: muscle spasms, hair loss,
change in how things taste or loss of taste, weight loss, tiredness,
nausea, diarrhea, decreased appetite, constipation, vomiting and joint
aches.
These are not all the possible side effects of Erivedge. For more
information, patients should ask their healthcare provider or pharmacist.
Because everyone is different, it is not possible to predict what side
effects any one person will have or how severe they may be. Patients
should tell their healthcare provider if they have any side effect that
bothers them or that does not go away.
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.
Please see the full Prescribing Information and the Medication Guide for
serious side effects and additional important safety information at http://www.erivedge.com.
About Tarceva
Indication
Tarceva is approved as a first-line treatment, maintenance treatment,
and second- or third-line treatment for advanced-stage non-small cell
lung cancer (NSCLC).
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Tarceva is prescribed as initial treatment for patients with NSCLC,
whose cancer has spread to other parts of the body and that has
certain types of Epidermal Growth Factor Receptor (EGFR) mutations.
(First-line treatment)
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Tarceva is prescribed as maintenance treatment for advanced-stage
NSCLC in patients whose cancer has not spread or grown after prior
treatment with certain types of chemotherapy.
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Tarceva is prescribed as second- or third-line treatment for
advanced-stage NSCLC in patients whose cancer has spread or grown
after receiving at least one round of chemotherapy.
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Tarceva is not meant to be used at the same time as certain types of
chemotherapy for advanced NSCLC.
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For initial treatment with NSCLC whose cancer has not spread to other
parts of the body, it is not known if Tarceva is safe and effective in
other EGFR mutations.
Important Safety Information
The following serious adverse reactions, which include deaths, were
reported in patients taking Tarceva: Interstitial Lung Disease (ILD)
events; liver and/or kidney problems; gastrointestinal (GI) perforations
(the development of a hole in the stomach, small intestine, or large
intestine); serious skin conditions; blood, bleeding and clotting
problems (heart attack or stroke); eye disorders (dry eyes, eye
irritation, and damage to the cornea); bleeding events when taking
warfarin or non-steroidal anti-inflammatory drugs (NSAIDs); pregnancy
(women should avoid becoming pregnant and avoid breastfeeding while
taking Tarceva).
Patients should call their doctor right away if they have these signs
or symptoms: Serious or ongoing diarrhea, nausea (feeling sick to
the stomach), loss of appetite, or vomiting; new or worsening shortness
of breath or cough; eye irritation; new or worsening rash, blistering or
peeling of the skin; any changes in smoking habits.
The most common side effects include:
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First-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness
of breath, and loss of appetite.
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Maintenance/Second- or Third-Line NSCLC treatment: Rash and diarrhea.
Patients should call their doctor for medical advice about side effects.
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 see the full Prescribing Information for additional important
safety information at http://www.tarceva.com.
About Zelboraf
Indication
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.
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.
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, abnormal
liver function tests 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 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.
Copyright Business Wire 2014