-- Roche Plans to Seek Approval with Health Authorities Based on Encouraging Results --
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that CLEOPATRA, a pivotal Phase III study, met its primary endpoint. The study showed that people with HER2-positive metastatic breast cancer (mBC) who received the combination of two targeted medicines, pertuzumab and Herceptin® (trastuzumab), plus docetaxel chemotherapy lived significantly longer without their disease getting worse (progression-free survival, PFS) than people who received only Herceptin and docetaxel.
No new safety signals were observed and adverse events were consistent with those seen in previous studies of pertuzumab and Herceptin, either in combination or alone. Data from CLEOPATRA will be submitted for presentation at an upcoming medical meeting.
Despite significant progress, HER2-positive mBC remains an incurable disease.
“These results with pertuzumab combined with Herceptin and docetaxel are very encouraging and represent our commitment to developing potential new personalized options for people with this aggressive disease,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We plan to submit the study results for global regulatory approval this year.”
About the CLEOPATRA Study
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is a Phase III, randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety profile of pertuzumab combined with Herceptin and docetaxel chemotherapy compared to Herceptin and docetaxel in people with HER2-positive mBC.
The two-arm study enrolled 808 people with previously untreated HER2-positive mBC from 19 countries worldwide.
- Participants in the pertuzumab arm received:
- Docetaxel 75-100 mg/m2 every three weeks for six cycles or until progression
- Herceptin 8 mg/kg loading dose followed by 6 mg/kg every three weeks
- Pertuzumab 840 mg loading dose followed by 420 mg every three weeks
- Participants in the Herceptin plus docetaxel arm received:
- Docetaxel 75-100 mg/m2 every three weeks for six cycles or until progression
- Herceptin 8 mg/kg loading dose followed by 6 mg/kg every three weeks
The primary study endpoint was PFS as assessed by an independent review. Secondary endpoints are overall survival (OS), safety profile, overall response rate (ORR), duration of remission, quality of life and correlation of biomarkers with clinical outcomes.
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. 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)-negative 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
Metastatic Gastric Cancer:
Herceptin is approved in combination with the chemotherapy drugs cisplatin, and either capecitabine or 5-fluorouracil, for metastatic HER2-positive stomach cancer or cancer of the gastroesophageal junction, in men and women who have not received prior medicines for their 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 or stomach cancer 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.
The most common side effects associated with Herceptin in patients with stomach cancer are low white blood cell counts, diarrhea, fatigue, low red blood cell counts, inflammation of the lining of the mouth, weight loss, upper respiratory tract infections, fever, low platelet counts, swelling of mucus membranes, swelling of the nose and throat, and a change in taste.
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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