Roche announced last month (October 2011) that the Phase III HannaH study demonstrated that a new, subcutaneous (SC) formulation of Herceptin (trastuzumab) performed similarly to the standard intravenous (IV) infusion of Herceptin in women with HER2-positive early breast cancer.
The SC administration takes around five 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 of Herceptin SC may also significantly reduce pharmacy time as no medicine preparation time is required.
BCAC Chair Libby Burgess says “The obvious advantage of the SC administration of Herceptin is that it may offer patients a less time-consuming and more convenient way of receiving their treatment while not compromising its effectiveness. An added benefit will be that reduced treatment time would free up medical teams and facilities, allowing more patients to be treated in a timely manner.”
Herceptin SC uses Enhanze™ Technology, developed by Halozyme Therapeutics, Inc. 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.
HannaH is a Phase III, open-label study involving 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 study met both its 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 (anaemia and low white blood count).
Further clinical trials will be undertaken before the new formulation can be registered and made available to patients.
Source: Roche press release, Basel, October 18, 2011 http://www.roche.com/media/media_releases/med-cor-2011-10-18.htm
