Genentech’s Kadcyla Reduced the Risk of Disease Recurring in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

– Phase III KATHERINE study shows Kadcyla®
significantly improved invasive disease-free survival compared to
Herceptin
® in people with HER2-positive early breast
cancer with residual disease after neoadjuvant treatment –

– Data will be submitted to health authorities around the world,
including the U.S. Food and Drug Administration and European Medicines
Agency –

– Results will be presented at the 2018 San Antonio Breast Cancer
Symposium in December –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced the Phase III KATHERINE study met its primary endpoint,
showing Kadcyla® (ado-trastuzumab emtansine) as a single
agent significantly reduced the risk of disease recurrence or death
(invasive disease-free survival, iDFS) compared to Herceptin®
(trastuzumab) as an adjuvant (after surgery) treatment in people with
HER2-positive early breast cancer (EBC) who have residual disease
(pathological invasive residual disease in the breast
and/or axillary nodes) present following neoadjuvant (before surgery)
treatment. The safety profile of Kadcyla in the KATHERINE study was
consistent with previous clinical trials and no new safety signals were
identified.

“We are highly encouraged by these positive results with adjuvant
Kadcyla treatment in people with HER2-positive early breast cancer who
have residual disease after neoadjuvant therapy,” said Sandra Horning,
M.D., chief medical officer and head of Global Product Development. “We
look forward to discussions with regulatory authorities with the goal of
bringing this new treatment option to patients as soon as possible.”

Full results will be submitted to health authorities around the world,
and will be presented at the 2018 San Antonio Breast Cancer Symposium on
Wednesday, December 5, 2018 at 11:00 a.m. CST.

The KATHERINE trial investigated a population of people with
HER2-positive EBC who did not achieve a pathological complete response
to neoadjuvant treatment. This state of residual disease is associated
with a worse prognosis.

The goal in treating early breast cancer is to provide people with the
best chance for a cure. While we come closer to this goal with each
advance, many people still have a disease recurrence in the long-term.
Neoadjuvant treatment is given before surgery with the goal of shrinking
tumors and helping to improve surgical outcomes. Adjuvant treatment is
given after surgery as part of a complete EBC treatment regimen and is
aimed at eliminating any remaining cancer cells in the body to help
reduce the risk of the cancer returning.

About the KATHERINE study

KATHERINE is an international, multi-center, two-arm, randomized,
open-label, Phase III study evaluating the efficacy and safety of
Kadcyla versus Herceptin as an adjuvant therapy in people with
HER2-positive EBC who have pathological invasive residual disease in the
breast and/or axillary lymph nodes following neoadjuvant therapy that
included Herceptin and taxane-based chemotherapy. The primary endpoint
of the study is iDFS, which in this study is defined as the time from
randomization to invasive breast cancer recurrence or death from any
cause. Secondary endpoints include disease-free survival and overall
survival.

About HER2-positive breast cancer

Breast cancer is the most common cancer among women worldwide. According
to the American Cancer Society, approximately 269,000 people in the
United States will be diagnosed with breast cancer, and more than 41,000
will die from the disease in 2018. Breast cancer is not one, but many
diseases based on the biology of each tumor. In HER2-positive breast
cancer, there is excess HER2 protein on the surface of tumor cells.
Approximately 15-20 percent of breast cancers are HER2-positive based on
the result of a diagnostic test.

About Kadcyla

Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent
chemotherapy directly to HER2-positive cancer cells, designed to limit
damage to healthy tissues, although it can still affect them. Kadcyla
can cause serious side effects. It combines two anti-cancer agents using
a stable linker: the HER2-targeting trastuzumab (the active ingredient
in Herceptin) and the chemotherapy agent DM1. Kadcyla is the only ADC
approved for the treatment of HER2-positive metastatic breast cancer. In
the U.S., Genentech licenses technology for Kadcyla under an agreement
with ImmunoGen, Inc.

Kadcyla Indication Statement

Kadcyla® (ado-trastuzumab emtansine), as a single agent, is
indicated for the treatment of patients with HER2-positive, metastatic
breast cancer who previously received trastuzumab and a taxane,
separately or in combination. Patients should have either:

  • Received prior therapy for metastatic disease, or
  • Developed disease recurrence during or within six months of completing
    adjuvant therapy.

Important Safety Information

What is the most important safety information patients should know
about Kadcyla?

Kadcyla is not the same medicine as trastuzumab (Herceptin).

Liver problems

  • Kadcyla may cause severe liver problems that can be life threatening.
    Symptoms of liver problems may include vomiting, nausea, eating
    disorder (anorexia), yellowing of the skin (jaundice), stomach pain,
    dark urine or itching.

Heart problems

  • Kadcyla may cause heart problems, including those without symptoms
    (such as reduced heart function) and those with symptoms (such as
    congestive heart failure). Symptoms may include swelling of the ankles
    or legs, shortness of breath, cough, rapid weight gain of greater than
    five pounds in less than 24 hours, dizziness or loss of consciousness,
    or irregular heartbeat.

Pregnancy

  • Receiving Kadcyla during pregnancy can result in the death of an
    unborn baby and birth defects. Birth control should be used while
    receiving Kadcyla and for seven months after the last dose of Kadcyla.
  • If a patient is exposed to Kadcyla during pregnancy, or becomes
    pregnant within seven months of their last dose of Kadcyla, she should
    contact her healthcare provider right away; she is also encouraged to
    enroll in the MotHER Pregnancy Registry by calling (800) 690-6720 or
    visiting http://www.motherpregnancyregistry.com.
  • Patients are also encouraged to report exposure to Kadcyla during
    pregnancy, or if they become pregnant within seven months of their
    last dose, to Genentech by calling (888) 835-2555.
  • If the patient is a mother who is breastfeeding, she should talk with
    her doctor about either stopping breastfeeding or stopping Kadcyla.

Patients should contact their doctor right away if they experience
symptoms associated with these side effects.

Additional possible serious side effects of Kadcyla

Lung problems

  • Kadcyla may cause lung problems, including inflammation of the lung
    tissue, which can be life-threatening. Signs of lung problems may
    include trouble breathing, cough, tiredness and fluid in the lungs.

Infusion-related reactions

  • Symptoms of an infusion-related reaction may include one or more of
    the following: the skin getting hot or red (flushing), chills, fever,
    trouble breathing, low blood pressure, wheezing, tightening of the
    muscles in the chest around the airways or a fast heartbeat. A
    patient’s doctor will monitor the patient for infusion-related
    reactions.

Serious bleeding

  • Kadcyla can cause life-threatening bleeding. Taking Kadcyla with other
    medications used to thin the blood (antiplatelet) or prevent blood
    clots (anticoagulation) can increase the risk of bleeding. A patient’s
    doctor should provide additional monitoring if the patient is taking
    one of these other drugs while on Kadcyla. Life-threatening bleeding
    may also happen with Kadcyla, even when blood thinners are not also
    being taken.

Low platelet count

  • Low platelet count may happen during treatment with Kadcyla. Platelets
    help the blood to clot. Signs of low platelets may include easy
    bruising, bleeding, and prolonged bleeding from cuts. In mild cases
    there may not be any symptoms.

Nerve damage

  • Symptoms may include numbness and tingling, burning or sharp pain,
    sensitivity to touch, lack of coordination, muscle weakness, or loss
    of muscle function.

Skin reactions around the infusion site

  • Kadcyla may leak from the vein or needle and cause reactions such as
    redness, tenderness, skin irritation, or pain or swelling at the
    infusion site. If this happens, it is more likely to happen within 24
    hours of the infusion.

HER2 testing and Kadcyla

Patients must have a HER2 test to determine if their cancer is
HER2-positive before taking Kadcyla, because benefit has been shown only
in patients whose tumors are HER2-positive.

Most common side effects of Kadcyla

The most common side effects seen in people taking Kadcyla were:

  • Tiredness
  • Nausea
  • Pain that affects the bones, muscles, ligaments and tendons
  • Bleeding
  • Low platelet count
  • Headache
  • Liver problems
  • Constipation
  • Nosebleeds

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.kadcyla.com.

Herceptin Indication Statement

Adjuvant Breast Cancer

Herceptin is approved for the treatment of early-stage breast cancer
that is Human Epidermal growth factor Receptor 2-positive
(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 (doxorubicin) based therapy (a type of chemotherapy)

Patients are selected for therapy based on an FDA-approved test for
Herceptin.

*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 an unborn baby or birth defects.
Contraception should be used while receiving Herceptin and for seven
months 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
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.

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 Genentech in breast cancer

Genentech has been advancing breast cancer research for more than 30
years with the goal of helping as many people with the disease as
possible. Our medicines, along with companion diagnostic tests, have
substantially improved outcomes for HER2-positive breast cancer. As our
understanding of breast cancer biology rapidly improves, we are working
to identify new biomarkers and approaches to treatment for other
subtypes of the disease, including triple-negative and hormone
receptor-positive.

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.

Contacts

Genentech
Media Contact:
Courtney Aberbach, (650) 467-6800
or
Advocacy
Contact:
Katie Creme Henry, (202) 258-8228
or
Investor
Contacts:
Loren Kalm, (650) 225-3217
Karl Mahler, 011 41 61
687 8503