New Data from Phase III Study Showed that People with HER2-Postive Metastatic Breat Cancer Lived Longer with Genetech's Perjeta
SOUTH SAN FRANCISCO, Calif. – June 21, 2012 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that people with HER2-positive metastatic breast cancer (mBC) lived significantly longer (overall survival) when treated with the combination of Perjeta™ (pertuzumab), Herceptin® (trastuzumab) and docetaxel chemotherapy, compared to Herceptin and docetaxel chemotherapy alone in the Phase III CLEOPATRA study. These data will be submitted for presentation at an upcoming medical meeting.
"We are pleased that Perjeta helped people with HER2-positive metastatic breast cancer live longer and lengthened the time they lived without their disease worsening," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "The improvement in survival seen in the CLEOPATRA study is great news for patients and doctors, and reinforces our belief that Perjeta will improve the outlook for people with this devastating disease."
Perjeta is a personalized medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different places on the HER2 receptor.
The FDA recently approved Perjeta in combination with Herceptin and docetaxel chemotherapy for the treatment of people with HER2-positive mBC who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, based on the results of the CLEOPATRA study. Roche has also submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for Perjeta for people with previously untreated HER2-positive mBC.
CLEOPATRA Study Results
This analysis of overall survival in the CLEOPATRA study crossed the pre-specified boundary showing that the combination of Perjeta, Herceptin and docetaxel chemotherapy significantly improved overall survival in people with HER2-positive mBC, compared with Herceptin and chemotherapy. Overall survival is a secondary endpoint of the CLEOPATRA study.
The final progression-free survival (PFS, the primary endpoint) and safety profile data from the CLEOPATRA study were published in December 2011 in the New England Journal of Medicine and demonstrated that people who received Perjeta in combination with Herceptin and docetaxel chemotherapy had a statistically significant 38 percent reduction in the risk of their disease worsening or death (PFS, HR=0.62, p-value less than 0.0001) compared to people who received Herceptin and chemotherapy plus placebo. The median PFS improved by 6.1 months from 12.4 months for people who received Herceptin and chemotherapy plus placebo to 18.5 months for those who received Perjeta, Herceptin and chemotherapy.
In CLEOPATRA, the most common adverse reactions (rate greater than 30 percent) seen with Perjeta in combination with Herceptin and docetaxel chemotherapy were diarrhea, hair loss, low white blood cell count with or without fever, upset stomach, fatigue, rash and peripheral neuropathy (numbness, tingling or damage to the nerves). The most common Grade 3-4 adverse reactions (rate greater than 2 percent) were low white blood cell count with or without fever, decrease in a certain type of white blood cell, diarrhea, damage to the nerves, decrease in red blood cell count, weakness and fatigue.
About the CLEOPATRA Study
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, Phase III, randomized, double-blind, placebo-controlled study. The study evaluated the efficacy and safety profile of Perjeta combined with Herceptin and docetaxel chemotherapy compared to Herceptin and chemotherapy plus placebo in 808 people with previously untreated HER2-positive mBC or with HER2-positive mBC that had recurred after prior therapy in the adjuvant or neoadjuvant setting.
The primary endpoint of the study was PFS as assessed by an independent review committee. Secondary endpoints were overall survival, PFS by investigator assessment, safety profile, overall response rate (ORR), duration of response and time to symptom progression.
About Perjeta (pronounced per JET uh); pertuzumab (pronounced per TOO zuh mab)
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, Herceptin and docetaxel chemotherapy is thought to provide a more comprehensive blockade of HER signaling pathways.
Perjeta Indication Statement
Perjeta™ (pertuzumab) is approved for use along with trastuzumab and docetaxel (chemotherapy) in people with 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
• Perjeta has been shown to work only in people with HER2-positive breast cancer. Patients must have a HER2 test to know if their breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as Perjeta.
• Because side effects from this treatment are common, it is important to know what side effects may happen and what symptoms patients should watch for.
• A patient's doctor may stop treatment if serious side effects happen. Patients must contact their healthcare team right away if they have questions or are worried about any side effects.
Serious Side Effect of Perjeta
Most Serious Side Effect: 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 six months after a patient's last dose of Perjeta. Patients who are breastfeeding should talk with their doctor about either stopping breastfeeding or stopping Perjeta.
• If a patient is exposed to Perjeta during pregnancy, they are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720.
Other Possible Side Effects
• Heart problems: Perjeta can result in 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.
• 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, trastuzumab, and docetaxel were fatigue, loss of taste, allergic reactions, muscle pain and vomiting.
• Severe allergic reactions: Some people receiving Perjeta may have severe allergic reactions, calledhypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly and may affect many areas of the body.
Most Common Side Effects
The most common side effects of Perjeta when given with trastuzumab and docetaxel are diarrhea, hair loss, low levels of white blood cells with or without a fever, upset stomach, fatigue, rash and damage to the nerves (numbness, tingling, pain in hands/feet).
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visithttp://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Perjeta full Prescribing Information including Most Serious Side Effect for additional Important Safety Information. For more information about Perjeta, visit http://www.perjeta.com.
Herceptin is a personalized medicine designed to specifically block the HER2 protein on the surface of some cancer cells. Based on preclinical studies, this biologic antibody is believed to 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.
Herceptin has two approved uses in metastatic breast cancer (mBC):
• Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of HER2-positive mBC.
• Herceptin alone is approved for the treatment of HER2-positive mBC in patients who have received one or more chemotherapy regimens for metastatic disease.
Important Safety Information
Herceptin treatment can result in heart problems, including for those patients without symptoms (such as reduced heart function) and those patients with symptoms (such as congestive heart failure). One patient died in an adjuvant breast cancer trial from significantly weakened heart muscle. The risk and seriousness of these heart problems were highest in patients 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 multigated acquisition (MUGA) scan. Some early-stage 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), and 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 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.
Because everyone is different, it is not possible to predict what side effects any one patient 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, athttp://www.herceptin.com.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 229,000 people will be diagnosed with breast cancer, and 40,000 will die from the disease in 2012. 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.
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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.