Herceptin Given Prior To Surgery Improves The Chance Of Survival Without Relapse

[dr-awale]

Standard one year Herceptin treatment provides long-term benefit to patients with high risk of recurrence

About 70% of women with locally advanced HER2-positive breast cancer were free of their disease three years after initiation of therapy when treated with Herceptin plus chemotherapy before surgery, compared to only around 50% of patients receiving pre-operative chemotherapy alone. These results from the final analysis of the NOAH (NeOAdjuvant Herceptin) phase III study will be presented today at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). This is welcome news as patients with this early, but locally advanced breast cancer whose disease has spread to tissues around the breast such as the skin, muscle or lymph nodes generally face a high chance of recurrence and short life-expectancy.

"The positive results of the NOAH study show that starting Herceptin treatment prior to surgery offers long-term benefits to women with HER2-positive breast cancer," said William M. Burns, CEO Division Roche Pharmaceuticals. "Herceptin continues to provide women with early breast cancer a much improved prognosis, even if their cancer has advanced locally."

"Women with locally advanced HER2-positive breast cancer are difficult to treat" said Professor Luca Gianni from the Istituto Nazionale Tumori Milano, Milan, Italy, a leading investigator of the NOAH trial. "The results of the NOAH study imply that starting chemotherapy with one year of Herceptin should become the standard of care for women with locally advanced HER2-positive breast cancer".

The aim of pre-surgery (neoadjuvant) therapy given to women with breast cancer is to improve the local control of the tumour to facilitate surgery. At the same time, the objective is to determine the sensitivity of the tumour towards a specific treatment. The NOAH study is the largest randomized Phase III trial evaluating the benefits of giving neoadjuvant Herceptin in combination with chemotherapy versus chemotherapy alone to women with locally advanced HER2-positive breast cancer. The results of this study demonstrate that starting Herceptin treatment prior to surgery helps shrink locally advanced breast cancer and improve long term outcomes.

About the NOAH study

The NOAH (NeOAdjuvant Herceptin) trial is a multicentre, randomised, open-label trial of 228 patients with centrally confirmed locally Advanced HER2-positive Breast Cancer (LABC), a particularly aggressive form of the disease. 115 patients received standard chemotherapy plus Herceptin (for one year) and 113 patients received chemotherapy alone before surgery. The primary end point was event-free survival (EFS), defined as the time between randomisation and disease recurrence or progression, or death from any cause. Secondary end points were pathological complete response (pCR), overall response rate (ORR), overall survival (OS) and safety.

The final NOAH phase III study results demonstrated that Herceptin plus chemotherapy improved event free survival at 3 years to 70% vs 53% with chemotherapy alone - the addition of Herceptin to chemotherapy reduced the relative risk of recurrence by about half (HR 0.56, p=0.006). In addition, Herceptin plus chemotherapy was shown to completely eradicate the tumour (a pathological complete response to treatment) in nearly twice as many patients, 39%, compared with only 20% of patients treated with chemotherapy alone (p=0.002). The overall response rate was also significantly increased (89% vs 77%, p=0.02).

About breast cancer

Breast cancer is the most common cancer among women worldwide.1 Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually.2

In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as 'HER2-positivity.' High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20 percent of women with breast cancer.

About Herceptin (trastuzumab)

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. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2-positive breast cancer.

Herceptin received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000, and for early HER2-positive breast cancer in 2006. In the advanced setting, Herceptin is now approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In the early setting, Herceptin is approved for use following standard (adjuvant) chemotherapy.

Herceptin is currently being evaluated for treatment of HER2-positive gastric cancer through an extensive international clinical trial programme.

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 more than half a million patients with HER2-positive breast cancer worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com