Tuesday, Nov 29, 2011

Genentech to Present Important New Data for HER2-Positive Breast Cancer at 2011 San Antonio Breast Cancer Symposium

South San Francisco, Calif. -- November 29, 2011 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the company will present results from studies of its investigational medicine pertuzumab in HER2-positive breast cancer at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium December 6-10. This includes data from the first randomized Phase III study of pertuzumab in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy (CLEOPATRA). The mechanisms of action of pertuzumab and Herceptin are believed to complement each other, as both bind to the HER2 receptor but on different regions.

"We are making additional substantial progress against HER2-positive breast cancer, a disease for which we have already dramatically changed the standard of care and improved patient outcomes," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Data at this conference reaffirm our commitment to discovering new treatments for HER2-positive breast cancer."

Data from the VIRGO metastatic breast cancer registry will also be presented. These data emphasize the importance of accurate HER2 diagnostic testing in ensuring that the HER2 status of breast cancer is accurately identified, and that people subsequently receive appropriate treatment for their disease.

Key Study Results to be Presented at SABCS
Pertuzumab

• Full results from CLEOPATRA, a randomized Phase III pivotal study that compared the combination of pertuzumab, Herceptin and docetaxel chemotherapy to Herceptin and chemotherapy alone in people with previously untreated HER2-positive metastatic breast cancer, will be presented by Professor Jose Baselga, M.D., Ph.D., chief of hematology/oncology and associate director of the Massachusetts General Hospital Cancer Center. Pertuzumab is an investigational medicine known as a HER2 dimerization inhibitor (HDI). This is the first time progression-free survival (PFS) data from a randomized study of pertuzumab will be presented, and study results will be featured in a SABCS press briefing.

  
  CLEOPATRA: A Phase III, Randomized, Double-Blind, Placebo-Controlled Registration Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Patients with Previously Untreated HER2-Positive Metastatic Breast Cancer (CLEOPATRA). (Abstract #S5-5). SABCS press briefing, Thursday, December 8, 7:30 a.m. CST. Oral presentation, General Session 5, Friday, December 9, 10:30 a.m. CST, Exhibit Hall D.

  
  

• Biomarker analyses from NEOSPHERE, a four-arm randomized Phase II neoadjuvant study evaluating the combination of pertuzumab, Herceptin and chemotherapy in people with newly diagnosed, early-stage HER2-positive breast cancer will be presented by Luca Gianni, M.D., director of medical oncology at the San Raffaele Cancer Center in Milan, Italy. At the 2010 SABCS, the NEOSPHERE data showed giving this combination to people in the neoadjuvant setting significantly improved the rate of complete tumor disappearance (pathological complete response rate, pCR) in the breast by more than half, compared to Herceptin plus chemotherapy without pertuzumab.

  
  NEOSPHERE: Neoadjuvant pertuzumab (P) and trastuzumab (H): Biomarker analyses of a 4-arm randomized Phase II study ('NeoSphere') in patients (pts) with HER2-positive breast cancer (BC). (Abstract #S5-1). Oral presentation, General Session 5, Friday, December 9, 9:30 a.m. CST, Exhibit Hall D.

  
  

• Results from TRYPHAENA, a randomized Phase II neoadjuvant study investigating the combination of pertuzumab and Herceptin with or without an anthracycline-based chemotherapy regimen, will be presented by Professor Andreas Schneeweiss, director of gynecological oncology at the National Center for Tumor Diseases, University Hospital Heidelberg, Germany.

  
  TRYPHAENA: Neoadjuvant pertuzumab and trastuzumab concurrent or sequential with an anthracycline-containing regimen or concurrent with an anthracycline-free standard regimen: a randomized Phase II study (TRYPHAENA). (Abstract #S5-6). Oral presentation, General Session 5, Friday, December 9, 10:45 a.m. CST, Exhibit Hall D.

HER2 Testing

• Data from the VIRGO metastatic breast cancer registry will be presented. The results underscore the importance of accurate diagnostic testing, which could potentially impact treatment decisions for many people with breast cancer. Results being presented will specifically address rates of people misdiagnosed with HER2-negative breast cancer.

  
  VIRGO: Discordance between central and local laboratory HER2 testing from a large HER2-negative population in VIRGO, a metastatic breast cancer registry. (Abstract #P1-07-02). Poster Session 1, Prognosis/Response Predictions: Biomarkers - Methods, Wednesday, December 7, 5:00 p.m. CST, Exhibit Halls A-B.

About Pertuzumab
Pertuzumab is a monoclonal antibody being studied in early-stage and metastatic 
HER2-positive breast cancer. It is an investigational HER2-targeted medicine called a HER2 dimerization inhibitor (HDI). HER dimerization (pairing) is believed to play an important role in the growth and formation of several different cancer types. Pertuzumab is the first investigational medicine developed to specifically prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3 and HER4). In doing so, pertuzumab is thought to block cell signaling, which may inhibit cancer cell growth or lead to the death of the cancer cell. Binding of pertuzumab to HER2 may also signal the body's immune system to destroy the cancer cells. The mechanisms of action of pertuzumab and Herceptin are believed to complement each other, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with Herceptin and chemotherapy is to determine if the combination may provide a more comprehensive blockade of HER signaling pathways.

About Breast Cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 230,000 women will be diagnosed with breast cancer, and 40,000 will die from the disease in 2011. 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 15-25 percent of women with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.

About Herceptin
Herceptin is a targeted medicine (not a chemotherapy) designed to specifically block the HER2 protein on the surface of some cancer cells. Based on preclinical studies, Herceptin may work by attaching to HER2 receptors to stop signals that make the tumor cells grow and divide, and also by signaling the body's immune system to destroy the cancer cells.

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-based therapy (a type of chemotherapy)

^*High risk is defined as estrogen receptor/progesterone receptor (ER/PR)-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer:
Herceptin has two approved uses in metastatic breast cancer:

• Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of HER2-positive metastatic breast cancer
• Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

Important Safety Information
Herceptin treatment can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). One patient died in an adjuvant (early) breast cancer trial from significantly weakened heart muscle. The risk and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline).

Before taking the first dose of Herceptin and during treatment, a patient's doctor should check to see if there are any health conditions that may increase the patient's chance of having serious heart problems. This includes a review of the patient's health history and tests to see how well the heart muscle is working. These tests may include an echocardiogram or a MUGA scan. Some early breast cancer patients may also need to have a test done after they have finished taking Herceptin to see how well their heart muscle is working.

Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported. These reactions usually occur during or within 24 hours of receiving Herceptin.

The patient's doctor may need to completely stop Herceptin treatment if the patient has a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath.

Herceptin can cause harm to the fetus (unborn baby), in some cases death to the fetus, when taken by a pregnant woman. Women who could become pregnant need to use effective birth control methods during Herceptin treatment and for at least six months after treatment with Herceptin. Nursing mothers treated with Herceptin should discontinue nursing or discontinue Herceptin.

Worsening of low white blood cell counts associated with chemotherapy has also occurred.

Patients must have a HER2 test to determine if their breast is HER2-positive before using Herceptin, as benefit has only been shown in patients who are HER2-positive.

The most common side effects associated with Herceptin in patients with breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. Patients with questions or concerns about side effects should talk to their doctor.

Patients should read the Herceptin Full Prescribing Information including Boxed WARNINGS, at http://www.herceptin.com.

About Genentech
Founded more than 30 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.

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