Phase III APHINITY Study Shows Genentech’s Perjeta® Regimen Helped People with an Aggressive Type of Early Breast Cancer Live Longer Without Their Disease Returning Compared to Herceptin® and Chemotherapy

– Perjeta plus Herceptin and chemotherapy showed a
statistically significant improvement in invasive disease-free survival
(iDFS) for people with HER2-positive early breast cancer (EBC) compared
to Herceptin and chemotherapy alone –

– Data will be discussed with health authorities, including
the U.S. Food and Drug Administration (FDA) and European Medicines
Agency (EMA) –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the
Breast International Group (BIG), Breast European Adjuvant Study Team
(BrEAST) and Frontier Science Foundation (FS) today announced positive
results from the Phase III APHINITY study. The study met its primary
endpoint and showed that adjuvant (after surgery) treatment with the
combination of Perjeta^® (pertuzumab), Herceptin^®
(trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a
statistically significant reduction in the risk of recurrence of
invasive disease or death (invasive disease-free survival; iDFS) in
people with HER2-positive early breast cancer (EBC) compared to
Herceptin and chemotherapy alone. The safety profile of the
Perjeta-based regimen was consistent with that seen in previous studies,
and no new safety signals were identified. Full results from the
APHINITY trial will be presented at an upcoming medical meeting in 2017.

“These results from the positive APHINITY study represent an important
addition to the body of data for Perjeta in the treatment of people with
HER2-positive early breast cancer,” said Sandra Horning, M.D., chief
medical officer and head of Global Product Development. “We look forward
to discussing these adjuvant results with global regulatory authorities.”

Gunter von Minckwitz, M.D., study coordinator from the Breast
International Group and academic study partners, added, “APHINITY
provides yet another example of the importance of industry-academic
collaborations and their value in advancing cancer care for people
affected by this challenging disease.”

HER2-positive breast cancer is an aggressive form of the disease, which
affects approximately one in five people with breast cancer and is
associated with a poor prognosis if left untreated. Despite advancements
in the treatment of HER2-positive EBC, up to one in three people treated
with Herceptin and chemotherapy may eventually see their cancer return.
Treatment options are needed to improve the outcomes of people with this
aggressive disease. Treating breast cancer early, before it has spread,
may improve the chance of preventing the disease from returning and
potentially reaching an incurable stage. Adjuvant therapy is given after
surgery and is aimed at killing any remaining cancer cells to reduce the
risk of the cancer returning.

In the U.S., the combination of Perjeta, Herceptin and docetaxel
chemotherapy is currently available under accelerated approval for
neoadjuvant treatment of patients with HER2-positive, locally advanced,
inflammatory, or early stage breast cancer (either greater than 2 cm in
diameter or node-positive) as part of a complete treatment regimen for
early breast cancer. This approval is based primarily on data from a
Phase II study showing that nearly 40 percent of people receiving the
combination of Perjeta, Herceptin and docetaxel chemotherapy had no
evidence of microscopic tumor tissue detectable at the time of surgery
(known as a pathological complete response, or pCR) compared to almost
22 percent in the Herceptin and docetaxel chemotherapy arm. The APHINITY
trial reflects the commitment to evaluate the Perjeta-based regimen as
part of a complete treatment approach for EBC. These data will be
discussed with the FDA with the hope to convert the current accelerated
approval to a full approval.

About APHINITY

APHINITY (Adjuvant Pertuzumab and Herceptin IN
Initial TherapY in Breast Cancer, NCT01358877/
BO25126/ BIG 4-11) is an international, Phase III, randomized,
double-blind, placebo-controlled, two-arm study evaluating the efficacy
and safety of Perjeta plus Herceptin and chemotherapy compared to
Herceptin and chemotherapy as an adjuvant therapy in 4,805 people with
operable HER2-positive EBC.

People enrolled in the study underwent surgery and were randomized to
one of two arms (1:1) to receive either:

• Six to eight cycles of chemotherapy (anthracycline or
  non-anthracycline-containing regimen) with Perjeta and Herceptin,
  followed by Perjeta and Herceptin every three weeks for a total of one
  year (52 weeks) of treatment.
• Six to eight cycles of chemotherapy (anthracycline or
  non-anthracycline-containing regimen) with placebo and Herceptin,
  followed by placebo and Herceptin every three weeks for a total of one
  year (52 weeks) of treatment.

Radiotherapy and/or endocrine therapy could be initiated at the end of
adjuvant chemotherapy. The APHINITY study allowed for a range of
standard chemotherapy regimens to be used and both lymph node-positive
and lymph node-negative participants were eligible for enrollment. The
primary efficacy endpoint of the APHINITY study is iDFS, which is the
time a patient lives without return of invasive breast cancer at any
site or death from any cause after adjuvant treatment. Secondary
endpoints include cardiac and overall safety, overall survival,
disease-free survival and health-related quality of life.

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, dual blockade of
HER signaling pathways, thus preventing tumor cell growth and survival.

Perjeta Indication Statement

Perjeta is approved for use prior to surgery in combination with
Herceptin and docetaxel chemotherapy in people with HER2-positive,
locally advanced, inflammatory, or early stage (tumor is greater than
two centimeters in diameter or node-positive) breast cancer. Perjeta
should be used as part of a complete treatment regimen for early stage
breast cancer. This use of Perjeta is based on an improvement in the
percentage of patients whose cancer shrinks or disappears after
treatment. Currently, no data have shown whether or not treatment with
Perjeta prior to surgery improves survival.

• The safety of Perjeta in combination with doxorubicin-containing
  regimens has not been established.
• The safety of Perjeta administered for greater than six cycles for
  early stage breast cancer has not been established.

Important Safety Information

Side effects with Perjeta

• Not all people have serious side effects; however, side effects with
  Perjeta therapy are common. It is important for a patient to know what
  side effects may happen and what symptoms a patient should watch for.
• A patient’s doctor may stop treatment if serious side effects happen.
  A patient should be sure to contact their healthcare team right away
  if they have questions or are worried about any side effects.

Most serious side effects

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.
• Based on test results, a patient’s doctor may hold or discontinue
  treatment with Perjeta.

Receiving Perjeta during pregnancy can result in the death of an
unborn baby and birth defects.

• Birth control should be used while receiving Perjeta and for seven
  months after a patient’s last dose of Perjeta. If a patient is a
  mother who is breastfeeding, the patient should talk with her doctor
  about either stopping breastfeeding or stopping Perjeta.
• If a patient thinks she may be pregnant, the patient should contact
  her healthcare provider immediately.
• If a patient is exposed to Perjeta during pregnancy, or becomes
  pregnant while receiving Perjeta or within seven months following the
  last dose of Perjeta in combination with Herceptin, the patient is
  encouraged to enroll in the MotHER Pregnancy Registry by contacting
  (800) 690-6720 or visiting http://www.motherpregnancyregistry.com,
  and to report Perjeta exposure to Genentech at (888) 835-2555.

Other possible serious side effects

• Perjeta should not be used in patients who are allergic to pertuzumab
  or to any of the ingredients in Perjeta.
• 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 were feeling tired, abnormal or altered taste, allergic
  reactions, muscle pain and vomiting. The most common infusion-related
  reactions when receiving Perjeta alone were fever, chills, feeling
  tired, headache, weakness, allergic reactions 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.

Knowing if Perjeta is right for the patient

Perjeta has only been shown to work in people with HER2-positive breast
cancer. A patient must have a HER2 test to know if their breast cancer
is HER2-positive before receiving an anti-HER2 treatment, such as
Perjeta.

Most common side effects

The most common side effects of Perjeta when given with Herceptin and
docetaxel as part of an early breast cancer regimen before surgery are:

• Hair loss
• Diarrhea
• Nausea
• Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin and
docetaxel following three cycles of epirubicin, cyclophosphamide and
fluorouracil as part of an early breast cancer regimen before surgery
are:

• Feeling tired
• Hair loss
• Diarrhea
• Nausea
• Vomiting
• Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin,
docetaxel and carboplatin as part of an early breast cancer regimen
before surgery are:

• Feeling tired
• Hair loss
• Diarrhea
• Nausea
• Vomiting
• Low levels of white blood cells with or without a fever
• Low platelet count
• Low levels of red blood cells

Patients are encouraged to report side effects to Genentech and the FDA.
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, including most serious side effects, at http://www.perjeta.com.

Herceptin Indication Statements

Early Breast Cancer

Herceptin is approved for the treatment of early stage breast cancer
that is HER2-positive and has spread into the lymph nodes, or is
HER2-positive and has not spread into the lymph nodes. If it has not
spread into the lymph nodes, the cancer needs to be estrogen
receptor/progesterone receptor (ER/PR)-negative or have one high risk
feature.* Herceptin can be used in several different ways:

• As part of a treatment course including the chemotherapy drugs
  doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel.
  This treatment course is known as “AC→TH.”
• With the chemotherapy drugs docetaxel and carboplatin. This treatment
  course is known as “TCH.”
• Alone after treatment with multiple other therapies, including an
  anthracycline-based therapy (a type of chemotherapy).

*High risk is defined as ER/PR-positive with one of the following
features: tumor size greater than 2 cm, age less than 35 years, or tumor
Grade 2 or 3.

Important Safety Information

Possible serious side effects with Herceptin

Not all people have serious side effects, but side effects with
Herceptin therapy are common.

Although some people may have a life-threatening side effect, most do
not.

A patient’s doctor will stop treatment if any serious side effects occur.

Herceptin is not for everyone. A patient should be sure to contact
their doctor if they are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced
heart function—with or without symptoms. The risk for and seriousness of
these heart problems were highest in people who received both Herceptin
and a certain type of chemotherapy (anthracycline). In a study of
adjuvant (early) breast cancer, one patient died of significantly
weakened heart muscle. A patient’s doctor will check for signs of heart
problems before, during, and after treatment with Herceptin.

INFUSION REACTIONS, including:

• Fever and chills
• Feeling sick to your stomach (nausea)
• Throwing up (vomiting)
• Pain (in some cases at tumor sites)
• Headache
• Dizziness
• Shortness of breath

These signs usually happen within 24 hours after receiving Herceptin.

A patient should be sure to contact their doctor if they:

Are a woman who could become pregnant, or may be pregnant

Herceptin may result in the death of unborn baby and birth defects.
Birth control should be used while receiving Herceptin and after a
patient’s last dose of Herceptin. If a patient is exposed to Herceptin
during pregnancy or within seven months of becoming pregnant, the
patient is encouraged to enroll in the MotHER Pregnancy Registry by
contacting (800) 690-6720 or visiting http://www.motherpregnancyregistry.com
and to report Herceptin exposure to Genentech at (888) 835-2555.

Have any signs of SEVERE LUNG PROBLEMS, including:

• Severe shortness of breath
• Fluid in or around the lungs
• Weakening of the valve between the heart and the lungs
• Not enough oxygen in the body
• Swelling of the lungs
• Scarring of the lungs

A patient’s doctor may check for signs of severe lung problems when he
or she examines the patient.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood
cell counts were seen more often in patients receiving Herceptin plus
chemotherapy than in patients receiving chemotherapy alone.

A patient’s doctor may check for signs of low white blood cell counts
when he or she examines the patient.

Other important information

Before taking Herceptin, a patient must have a HER2 test to determine if
their cancer is HER2-positive. This is because the benefit of treatment
with Herceptin has been shown only in patients whose tumors are
HER2-positive.

Side effects seen most often with Herceptin

Some patients receiving Herceptin for breast cancer had the following
side effects:

• Fever
• Feeling sick to your stomach (nausea)
• Throwing up (vomiting)
• Infusion reactions
• Diarrhea
• Infections
• Increased cough
• Headache
• Feeling tired
• Shortness of breath
• Rash
• Low white and red blood cell counts
• Muscle pain

A patient should contact their doctor immediately if they have any of
the side effects listed above.

Patients are encouraged to report side effects to Genentech and the FDA.
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, including Boxed WARNINGS and
additional Important Safety Information, at http://www.herceptin.com.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. According
to the American Cancer Society, approximately 255,180 people in the
United States will be diagnosed with breast cancer, and 41,070 will die
from the disease in 2017. In HER2-positive breast cancer, increased
quantities of the Human Epidermal growth factor Receptor
2 (HER2) are present on the surface of tumor cells. This is known
as “HER2 positivity” and affects approximately 15-20 percent of people
with breast cancer. HER2-positive cancer is a particularly aggressive
form of breast cancer.

About Genentech in HER2-positive Breast Cancer

Genentech has spent more than 30 years studying the role of HER2 in
cancer, and Perjeta is a result of this research. A diagnostic test is
used to determine if a person’s tumor is HER2-positive and whether
treatment with HER2-targeted medicines 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 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 1.5
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 40 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.

Contacts

Genentech
Media Contact:
Courtney Aberbach, 650-467-6800
or
Advocacy
Contact:
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or
Investor Contacts:
Neera
Dahiya Ravindran, M.D., 650-491-5281
Karl Mahler, Ph.D., 011 41 61
687 8503