2012 San Antonio Breast Cancer Meeting Highlights
Survival results of the CLEOPATRA Study were presented at the annual Breast Cancer Symposium held in San Antonio, U.S. These findings showed that the combination of Perjeta, Herceptin, and chemotherapy significantly extended the lives of women with HER2-positive metastatic breast cancer, compared to the standard treatment.
The study findings indicate that the risk of death was reduced by 34 percent for women who received Perjeta.
Adding Perjeta to baseline treatment made a major contribution towards achieving significant improvement in overall survival for patients with HER2-positive metastatic breast cancer.
Analysis of the results, after 3 years of follow-up, showed that most of the patients who were treated with Perjeta survived, constituting a 30% improvement in survival, compared to women who were treated with standard therapy alone.
Based on the impressive results of the CLEOPATRA study, women who received the Herceptin and chemotherapy combination have been offered the option to add Perjeta to the treatment combination.
According to Dr. Noa Efrat Ben-Baruch, Head, Department of Oncology at Kaplan Medical Center: "Up until 10 years ago, HER2-positive metastatic breast cancer was considered to be a violent, untreatable tumor. The arrival of Herceptin and its inclusion in the treatment equation constituted a genuine breakthrough, bringing about unprecedented improvement in survival of these patients. The results of the CLEOPATRA study illustrate an additional breakthrough, as the combination of Perjeta and Herceptin has led to significant improvement in survival without any side effects. Women who have HER2-positive metastatic breast cancer now have a treatment solution, which in many cases can keep the disease in check for an extended period."
The U.S. Federal Drug Administration approved Perjeta in June 2012 combined with Herceptin and Taxotere chemotherapy for the treatment for women who have HER2-positive breast cancer but have not received previous treatment for Stage IV (late-stage) disease. This treatment was approved in an accelerated-approval regulatory process reserved solely for drugs that have shown noteworthy and significant progress in treatment compared to previous treatments.
The European Union recently gave a positive recommendation for the use of the Perjeta label.
Today in Israel, the label registration is in its final stages, and an application was submitted for Perjeta's inclusion in the health package. Until the drug is officially approved for the health package, women who have HER2-positive metastatic cancer may receive treatment with Perjeta in a clinical study underway at 14 medical centers.
Perjeta is a biological personalized drug that targets the HER2 receptor, a protein found in large quantities on the outside of cancer cells in HER2-positive cancers. Perjeta operates using an innovative and targeted mechanism of action, which manifests itself in the delayed HER2 protein pairing. This process is deemed to be of great importance, delaying chain reactions within the cell, thereby preventing cancer cells from multiplying. Additionally, Perjeta, as an antibody, marks cancer cells as foreign cells in the body, thereby activating the body's immune response against them, and also induces tumor cell death.
Perjeta, used in combination with Herceptin, works according to two mechanisms of action that complement one another, and thus enable a more comprehensive obstruction of the intra-cellular signaling pathways of HER family receptors, which in turn results in a more effective delay of the growth and spread of malignancy.