Friday, Sep 27, 2013
South San Francisco, Calif. -- September 27, 2013 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Kadcyla® (ado-trastuzumab emtansine) significantly extended the time people with advanced HER2-positive breast cancer (metastatic and unresectable locally advanced/recurrent) lived without their disease worsening (progression-free survival [PFS], a co-primary endpoint) compared to people who received a treatment of their physician’s choice in an open-label Phase III study called TH3RESA. The data showed the risk of disease worsening or death was reduced by 47 percent for people who received Kadcyla (HR=0.528, p<0.0001). Data for overall survival, the other co-primary endpoint, are not yet mature. No new safety signals were observed with Kadcyla.
The study enrolled people with advanced HER2-positive breast cancer who had progressed despite prior treatment with at least two HER2-targeted medicines. It randomized people to receive either treatment with Kadcyla or a treatment of their physician’s choice. Eighty percent of people treated with physician’s choice received a regimen containing Herceptin® (trastuzumab).
“The TH3RESA study is the second large Phase III study in which Kadcyla has improved the amount of time patients with an advanced form of HER2-positive breast cancer lived without their tumor growing,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are pleased that the data from multiple clinical trials reinforces Kadcyla’s benefit for people with this aggressive disease.”
The late-breaking TH3RESA data will be presented tomorrow at the European Cancer Congress (ECC), by Dr. Hans Wildiers, University Hospital Leuven, Gasthuisberg, Belgium (Abstract #LBA15, Saturday, September 28, 2013 at 1:03 p.m. CEST). The data are also part of the official press program.
In February 2013, Kadcyla was approved by the U.S. Food and Drug Administration for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy. Kadcyla recently received a positive opinion from the European Union’s Committee for Medicinal Products for Human Use (CHMP) as a single agent for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin and a taxane, separately or in combination. A European Commission decision on EU marketing approval is expected by the end of the year.
About the TH3RESA Study
TH3RESA is a Phase III, randomized, open-label study comparing Kadcyla to the physician's choice of treatment in approximately 600 people with advanced HER2-positive breast cancer (metastatic or locally recurrent unresectable) who have received at least two prior treatments including Herceptin, lapatinib and a taxane. The co-primary endpoints are investigator-assessed PFS and OS. The secondary endpoints include objective response rate and safety profile.
Table summarizing PFS results from Kadcyla arm and Herceptin-based regimens from the treatment of physician’s choice arm
Kadcyla is an ADC being studied in HER2-positive cancers. It is the first ADC to result from Genentech’s 30 years of HER2 pathway research and the third medicine Genentech has developed for the treatment of HER2-positive breast cancer. Genentech licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.
Kadcyla Indication Statement
Kadcyla® (ado-trastuzumab emtansine) is approved for the treatment of people with HER2-positive metastatic breast cancer (MBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. People should either:
Important Safety Information
Kadcyla is not the same medicine as trastuzumab (Herceptin).
There are possible serious side effects of Kadcyla. Patients must contact their doctor right away if they experience any of these symptoms. The patient’s doctor may do tests before starting Kadcyla and before each dose to monitor for these side effects. Kadcyla treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects. Patients must contact their doctor right away if they experience any of these symptoms.
Additional Possible Serious Side Effects of Kadcyla
Low Platelet Count
Skin Reactions Around the Infusion Site
HER2 Testing and Kadcyla
Patients must have a HER2 test to determine if their cancer is HER2-positive before taking Kadcyla, as benefit has only been shown in patients whose tumors are HER2-positive.
Most Common Side Effects of Kadcyla
The most common side effects seen in people taking Kadcyla were:
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
For full Prescribing Information and Boxed WARNINGS on Kadcyla, please visit http://www.kadcyla.com.
Herceptin is a medicine designed to specifically block the HER2 protein on the surface of cells that overexpress the HER2 protein. 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 cells.
Adjuvant 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:
*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.
Metastatic Breast Cancer:
Herceptin has two approved uses in MBC:
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 stage) 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, feeling tired, 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.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.
Patients should read the Herceptin Full Prescribing Information including Boxed WARNINGS, 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 235,000 people in the United States will be diagnosed with breast cancer, and 40,000 will die from the disease in 2013. 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.
Founded more than 35 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.