Halozyme Therapeutics announced positive results from its Phase 3 HannaH study of subcutaneous (SC) Herceptin (trastuzumab) for the treatment of HER2-positive early breast cancer. HannaH is an open-label trial involving 596 women with HER2-positive early breast cancer. It was designed to compare trastuzumab concentration in the blood (pharmacokinetics), efficacy (pathologic complete response) and safety of Herceptin SC to that of Herceptin IV (Genentech). The trial met its co-primary endpoints that were trastuzumab serum concentrations and efficacy. Secondary endpoints included event-free survival and overall survival. In the trial the most common side effects seen were infections and abnormal blood counts (anemia and low white blood count) similar to other trials with chemotherapy and Herceptin IV.
The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.
Herceptin SC uses Enhanze Technology, developed by Halozyme which enables the injection of large volumes of a medication under the skin and enhances pharmacokinetics. It works by reversibly breaking down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.
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