Roche reports positive study of Herceptin given by subcutaneous injection

RocheRoche (SIX: RO, ROG; OTCQX: RHHBY) announced that the Phase III HannaH study demonstrated comparable efficacy of a new, investigational subcutaneous (SC) formulation of Herceptin (trastuzumab) to the standard intravenous (IV) infusion of Herceptin in women with HER2-positive early breast cancer. 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 given by subcutaneous injection has the potential to offer patients an effective, more convenient delivery option for this proven medicine," said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. "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."

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.

About the HannaH study
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 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 (anaemia and low white blood count).

About subcutaneous delivery
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.

About Herceptin
Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumour. The initial loading dose for IV Herceptin should be administered as a 90 minute infusion. If the initial loading dose is well tolerated, the subsequent doses can be administered as a 30-minute infusion. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer as well as HER2-positive advanced (metastatic) stomach cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve disease-free survival overall survival and response rates while maintaining quality of life in people with HER2-positive breast and stomach cancer. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat almost one million patients with HER2-positive breast and stomach cancer worldwide and is approved in more than 150 countries.

About Breast Cancer
Breast cancer is the most common cancer among women worldwide. Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 people will die of the disease annually.(1)

In HER2-positive breast cancer, increased quantities of the HER2 receptor are present on the surface of the tumour cells. This is known as 'HER2 positivity' and affects approximately 15-20 percent of people with breast cancer.(2)

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80'000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.

1. Ferlay J, et al. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10. Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr
2. Wolff A.C et al American Society of Clinical Oncology/ College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med—Vol 131, January 2007 Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

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