Sunday, Oct 14, 2018
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, CA -- October 14, 2018 --
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:
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
Heart problems
Pregnancy
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
Infusion-related reactions
Serious bleeding
Low platelet count
Nerve damage
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, 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:
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 factorReceptor 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:
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:
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:
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:
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.
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