New Phase III Trials to Begin for Trastuzumab in 2013


trastuzumabExemplary results in the 2012 Phase III trial coined EMILIA has led Roche Pharmaceuticals to initiate additional Phase III trials evaluating trastuzumab emtansine. The New Year brings registration trials for newly diagnosed as well as previously treated metastatic HER2-positive breast cancer patients. Trastuzumab will be evaluated in this 2013 study for three settings in earlier-stage disease: adjuvant use, neoadjuvant use and the treatment of patients with residual invasive disease following standard neoadjuvant therapy. As a type of immunotherapy known as a monoclonal antibody, trastuzumab is a man-made version of an immune system protein. Trastuzumab is uniquely designed to seek out and lock onto the protein called human epidermal growth factor receptor 2, or HER2. Roughly one out of every four breast and stomach cancers have abnormally higher numbers of these receptors on their cells’ surfaces. As soon as trastuzumab attaches to these cells it intervenes by initiating other immune cells to help kill these abnormal cells. The process is efficacious and successful. Trastuzumab is also useful in adjuvant therapy, alongside chemotherapeutic agents such as anthracyclines, as well as alongside surgery and radiation treatments.

HER-2The administration of trastuzumab in combination with or following chemotherapy has proven to be life saving for scores of patients with early stage HER2 gene amplification breast cancer.  Oncology Practice reported in mid- December 2012 that women who received paclitaxel and trastuzumab after anthracycline chemotherapy for HER2-positive breast cancer had roughly a 40% less risk of dying from the disease. These extremely encouraging statistics compared those patients who were administered paclitaxel and trastuzumab after anthracycline chemotherapy with those patients who were given only paclitaxel. This pair of landmark clinical trials assessed the risk of death by the ten year mark after initial treatment. Theranostics also play a significant part in the utilization of trastuzumab. Known as the brand name Herceptin, researchers are currently exploring the use of theranostics to individualize patient care and treatment. Defined as diagnostics that are closely tied to a specific drug treatment,  theranostics are an effectual part of testing and treatment for patients who are HER2 positive. If the patient is subsequently tested and diagnosed as HER-2 positive, a targeted treatment plan is implemented using trastuzumab. The advent of developing both diagnostic tests and targeted therapeutics in a collaborative manner is quickly becoming an integral option for individualizing patient treatment. Genentech’s Herceptin and DakoCytomation’s HercepTest are examples of this specific process in action, however, further research and development is greatly needed. Companies responding to this need can rest assured that LGM Pharma supplies trastuzumab, and other Monoclonal Antibodies (mAbs), with their complete support throughout the research and development process.

Trastuzumab-resultsIn addition to theranostics, strides are being made in gene identification and cancer risk. Oncology Nurse Advisor published an article on December 27, 2012 which offered exciting news regarding the genetic impact and cancer risk for patients. Results from a pivotal study led by Dr. Edith Perez, and researchers at the Mayo Clinic Comprehensive Cancer Center, announced that 25 genes have been identified that are considerably associated with a positive outcome, when the use of trastuzumab and chemotherapy are used concurrently in treatment. This eye opening study is thought to be the first to use gene expression profiling for predicting outcomes for trastuzumab as part of adjuvant breast cancer therapy. Trastuzumab is dosed based on height, weight, patient health and the type of cancer being treated.  Intravenous infusion is the typical method of delivery, and the first dose is usually given over a 90 minute time period. As a provider of API Trastuzumab CAS# 180288-69-1, LGM Pharma will assist clients with the entire process of research and development.

 

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