- Final data from Phase III CLEOPATRA
study showed people with previously untreated HER2-positive
metastatic breast cancer who received Perjeta, Herceptin and
docetaxel chemotherapy lived a median of 56.5 months compared to
40.8 months for people who received Herceptin and chemotherapy
- Median overall survival of almost five
years is the longest observed to date in people with this
aggressive type of advanced breast cancer
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced final survival results from the Phase III
CLEOPATRA study, which showed that adding Perjeta® (pertuzumab) to
Herceptin® (trastuzumab) and docetaxel chemotherapy extended the
lives (overall survival; OS) of people with previously untreated
HER2-positive metastatic breast cancer (MBC) by 15.7 months
compared to Herceptin and chemotherapy (median OS: 56.5 vs. 40.8
months). No new safety signals were observed in the study. These
data will be presented today in the Presidential Symposium at the
European Society for Medical Oncology (ESMO) 2014 congress in
Madrid, Spain (Abstract #350O_PR; Sunday, September 28, 4:00-5:30
p.m. CEST) and are also featured in the official ESMO Press
Briefing.
“Adding Perjeta to treatment with Herceptin and chemotherapy
resulted in the longest survival observed to date in a clinical
study of people with HER2-positive metastatic breast cancer,” said
Sandra Horning, M.D., chief medical officer and head of Global
Product Development. “The median survival of nearly five years for
people who received the Perjeta regimen is 15.7 months longer than
for people who received Herceptin and chemotherapy alone, a
magnitude of improvement we rarely see in clinical trials in
advanced cancer.”
Perjeta in combination with Herceptin and docetaxel chemotherapy
is approved in the United States and the European Union for people
with previously untreated HER2-positive MBC.
About the CLEOPATRA Study
CLEOPATRA (CLinical
Evaluation Of Pertuzumab And TRAstuzumab) was an international, Phase
III, randomized, double-blind, placebo-controlled study. The study
compared the combination of Perjeta, Herceptin and docetaxel
chemotherapy with placebo, Herceptin and chemotherapy in 808 people
with previously untreated HER2-positive MBC, or with HER2-positive
MBC that had come back after prior therapy in the adjuvant or
neoadjuvant setting. The primary endpoint of the study was
progression-free survival (PFS) as assessed by an independent
review committee. Secondary endpoints included OS and safety
profile.
An interim OS analysis from the CLEOPATRA study was previously
presented at the San Antonio Breast Cancer Symposium (SABCS) in
2012. At the time of the analysis, median OS had not yet been
reached for people receiving the Perjeta regimen as more than half
of these people continued to survive. The results to be presented
today are from the final pre-specified OS analysis after a median
follow-up of 50 months; median OS has now been reached for people
receiving the Perjeta regimen. These data will be submitted to
regulatory authorities around the world for inclusion in the
prescribing information for Perjeta. The safety profile of Perjeta
in this analysis was consistent with that observed previously in
the CLEOPATRA study, including Perjeta’s long-term cardiac safety.
No new safety signals were observed.
Updates to previously reported OS, PFS and safety profile data
from the CLEOPATRA study will also be presented today. These data
showed:
- The risk of death was reduced by 32
percent for people who received the Perjeta regimen, compared to
those who received Herceptin and chemotherapy (hazard ratio
[HR]=0.68, 95 percent CI 0.56-0.84; p=0.0002).
- People who received the Perjeta regimen
had a 32 percent reduction in the risk of their disease worsening
or death (PFS; HR=0.68, 95 percent CI 0.58-0.80) compared to people
who received Herceptin and chemotherapy.
- With longer follow-up, the median PFS
improvement of more than six months was maintained (median PFS of
18.7 months for people who received Perjeta, Herceptin and
chemotherapy compared to 12.4 months for those who received
Herceptin and chemotherapy).
- The most common adverse events (AEs,
rate greater than 50 percent or greater than 5 percent difference
between study groups) seen with the Perjeta regimen were hair loss,
diarrhea, low white blood cell count, rash, mucosal inflammation,
headache, upper respiratory tract infection, itching, low white
blood cell count with fever, dry skin and muscle spasms.
- The most common Grade 3-4 AEs (rate
greater than 10 percent) were low white blood cell count, low white
blood cell count with fever and a decrease in a certain type of
white blood cell.
About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein
found on the outside of many normal cells and in high quantities on
the outside of cancer cells in HER2-positive cancers. Perjeta is
designed specifically to prevent the HER2 receptor from pairing (or
“dimerizing”) with other HER receptors (EGFR/HER1, HER3 and HER4)
on the surface of cells, a process that is believed to play a role
in tumor growth and survival. Binding of Perjeta to HER2 may also
signal the body’s immune system to destroy the cancer cells. The
mechanisms of action of Perjeta and Herceptin are believed to
complement each other, as both bind to the HER2 receptor, but to
different places. The combination of Perjeta and Herceptin is
thought to provide a more comprehensive blockade of HER signaling
pathways.
Perjeta Indication Statement
Perjeta is approved for use in combination with Herceptin and
docetaxel chemotherapy in people who have HER2-positive breast
cancer that has spread to different parts of the body (metastatic)
and who have not received anti-HER2 therapy or chemotherapy for
metastatic breast cancer.
Important Safety Information
Most Serious Side Effects of Perjeta
Perjeta may cause heart problems, including those without
symptoms (such as reduced heart function) and those with symptoms
(such as congestive heart failure).
- A patient’s doctor may run tests to
monitor the patient’s heart function before and during treatment
with Perjeta.
Receiving Perjeta during pregnancy can result in the death of
an unborn baby and birth defects.
- Patients who think they may be pregnant
should contact their healthcare provider immediately.
- If patients are exposed to Perjeta
during pregnancy, they are encouraged to enroll in the MotHER
Pregnancy Registry by contacting (800) 690-6720.
Perjeta should not be used in patients who are allergic to
pertuzumab or to any of the ingredients in Perjeta.
Other Possible Serious Side Effects
- Infusion-related reactions: Perjeta is
a medicine that is delivered into a vein through a needle. This
process can cause reactions known as infusion-related reactions.
The most common infusion-related reactions when receiving Perjeta,
Herceptin and docetaxel chemotherapy were feeling tired, abnormal
or altered taste, allergic reactions, muscle pain and
vomiting.
- Severe allergic reactions: Some people
receiving Perjeta may have severe allergic reactions, called
hypersensitivity reactions or anaphylaxis. This reaction may be
severe, may happen quickly and may affect many areas of the
body.
Perjeta has only been shown to work in people with HER2-positive
breast cancer.
Most Common Side Effects
The most common side effects of Perjeta when given with
Herceptin and docetaxel chemotherapy for treatment of breast cancer
that has spread to other parts of the body (metastatic) are:
- Diarrhea
- Hair loss
- Low levels of white blood cells with or
without a fever
- Nausea
- Feeling tired
- Rash
- Damage to the nerves (numbness,
tingling, pain in hands/feet)
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 Perjeta full Prescribing Information, including Most
Serious Side Effects, for additional Important Safety Information
at http://www.perjeta.com.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide.
According to the American Cancer Society, approximately 235,000
people in the United States will be diagnosed with breast cancer,
and 40,000 will die from the disease in 2014. In HER2-positive
breast cancer, increased quantities of the Human
Epidermal growth factor Receptor 2 (HER2) are
present on the surface of the tumor cells. This is known as “HER2
positivity” and affects approximately 25 percent of people with
breast cancer. HER2-positive cancer is a particularly aggressive
form of breast cancer.
About Genentech and Roche in HER2-positive Breast
Cancer
Genentech and Roche have spent more than 30 years studying the
role of HER2 in cancer, and Perjeta is a result of this research. A
companion diagnostic test is used to determine if a person is
HER2-positive and whether treatment with Perjeta and Herceptin is
appropriate.
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 300 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 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:Susan Willson, 650-467-6800Advocacy
Contact:Sonali Chopra, 650-467-0842Investor Contacts:Nina Goworek,
650-467-8737Karl Mahler, 011 41 61 687 8503
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