Roche Reports Positive Herceptin Results
Swiss pharmaceutical company, Roche, yesterday announced that the Phase III HannaH study demonstrated comparable efficacy of a new, investigational subcutaneous formulation of Herceptin (trastuzumab) to the standard intravenous infusion of Herceptin in women with HER2-positive early breast cancer.
HannaH is a Phase III, open-label study consisting of 596 women with HER2 positive early breast cancer. The study was designed to compare trastuzumab concentration in the blood (pharmacokinetics), efficacy and safety of Herceptin SC to that of Herceptin IV.
The subcutaneous administration takes around 5 minutes to administer whereas the intravenous 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 compared to the intravenous method. The ready to use formula may also significantly reduce pharmacy time as no medicine preparation time is needed.
Herceptin subcutaneous uses Enhanze Technology, developed by Halozyme Therapeutics, which enables the injection of large volumes of a medication under the skin (subcutaneous). It works by reversibly breaking down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.
Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development, commented that “Herceptin given by subcutaneous injection has the potential to offer patients an effective, more convenient delivery option for this proven medicine.” “As a leader in innovative treatments for cancer, Roche is committed to a broad research program, including the development of new ways to administer our medicines.”
The study met its co-primary endpoints which were trastuzumab concentration in the blood (serum concentrations) and efficacy. Secondary endpoints included event-free survival and overall survival. In the study the most common side effects seen were infections and abnormal blood counts. No new safety signals were observed and adverse events were consistent with Herceptin IV.
Data from the study will be submitted for presentation at an upcoming medical meeting and will support a marketing application to regulatory authorities in the European Union.