Herceptin(R) Used Pre-Operatively Can Eradicate the Tumour in Nearly Twice as Many Patients as Chemotherapy Alone

CHICAGO, Illinois, June 3 /PRNewswire/ --

- Substantial Shrinkage of Cancer Tissue Increases Rate of Breast Conserving Surgery in Patients With Advanced HER2-Positive Disease

- FOR NON US MEDIA ONLY

New data presented today demonstrate that the addition of Herceptin(R) (trastuzumab) to chemotherapy prior to breast cancer surgery can significantly increase the response to therapy, resulting in substantial tumour shrinkage and even complete disappearance of the tumour. The phase III study presented at the American Society of Clinical Oncology (ASCO) Annual Meeting investigated the use of neoadjuvant (treatment given prior to surgery) Herceptin in combination with chemotherapy in patients with locally advanced HER2-positive breast cancer, a particularly aggressive form of the disease.

The NeOAdjuvant Herceptin (NOAH) study results demonstrated that Herceptin plus chemotherapy completely eradicated the tumour (a pathological complete response to treatment) in nearly twice as many patients (43%), compared with only 23% of patients treated with chemotherapy alone.(1) The study results are highly promising as this increased response to therapy not only results in breast conserving surgery, but could also translate into improved survival for patients.

"HER2-positive breast cancer remains a serious clinical diagnosis, as many patients will experience disease recurrence and progression. Neoadjuvant chemotherapy is administered to patients to help render inoperable tumours removable" said Professor L. Gianni, Director of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, in Milan. "The addition of Herceptin to neoadjuvant chemotherapy shows extremely positive benefits for patients".

HER2-positive breast cancer affects approximately 20-30 percent of women with breast cancer.(2) It demands special attention because the tumours are typically fast-growing and there is a high likelihood of relapse.

"These exciting results add to the substantial body of evidence of Herceptin as the foundation of care for HER2-positive breast cancer," said Dr. Jean-Jacques Garaud, Head of Global Drug Development at Roche. "As well as providing proven survival benefits in advanced HER2-positive breast cancer, and the best chance of a cure in early breast cancer, Herceptin has now demonstrated its potential to lessen the extent of surgery required for patients with locally advanced disease, which is very welcome news for patients with this particularly aggressive form of breast cancer."

Notes to Editors:

About NOAH

NOAH is a phase III trial assessing neoadjuvant Herceptin in combination with chemotherapy in patients with HER2-positive locally advanced breast cancer (LABC). 228 patients with centrally confirmed HER2-positive LABC were enrolled in the study. 115 patients received standard chemotherapy plus Herceptin (for one year) and 113 patients received chemotherapy alone before surgery. In parallel, 99 patients with HER2-negative breast cancer were treated with chemotherapy alone.

Adding Herceptin to chemotherapy significantly increased pathological complete response rate (43% vs 23%; p=0.002) and total pathological complete response rate (including eradication of tumour from lymph nodes) (38% vs 20%; p=0.003). Treatment was well tolerated with acceptable cardiac safety.

The trial is ongoing and event-free survival data are maturing.

The NOAH protocol is a joint effort of Fondazione Michelangelo, Grupo SOLTI and Roche.

About breast cancer

Breast cancer is the most common cancer among women worldwide.(3) 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.(4)

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 20-30 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. It has demonstrated efficacy in treating both early and advanced (metastatic) 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. In April 2007, Herceptin received European approval for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive breast cancer.

In the early setting, Herceptin is approved for use following standard (adjuvant) chemotherapy. 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 nearly 400,000 HER2-positive breast cancer patients 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, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.

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(1) Gianni L, et al., Neoadjuvant trastuzumab in locally advanced breast cancer (NOAH):antitumor and safety analysis. Abstract # 532. American Society of Clinical Oncology Annual Meeting 2007

(2) Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

(3) World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/

(4) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004

For further information please contact: Nils Eckardt F. Hoffmann-La Roche Ltd Mobile: [phone] [e-mail] Harriet Farmer Ketchum Mobile: [phone] [e-mail]