HERA (HERceptin Adjuvant) trial recruitment begins

October 24, 2001

HERA (HERceptin Adjuvant) Trial Recruitment Begins One of the largest ever breast cancer studies to look at the benefits of Herceptin® (trastuzumab) in Adjuvant Breast Cancer

11th European Cancer Conference, Lisbon, Portugal - Enrollment into one of the most challenging breast cancer trials ever will begin in November from over 600 trial sites across the world. It is hoped that more than 3000 patients will be recruited to take part in a study designed to determine if earlier use of the breast cancer drug Herceptin® (trastuzumab), increases disease-free survival for women with early breast cancer. The Breast International Group (BIG) and Roche are collaborating to conduct the HERceptin Adjuvant (HERA) Study, and it is anticipated that recruitment for this large-scale international Phase III clinical trial (HERA) will take place over a 48 month period.

Herceptin has already been shown to increase survival and improve quality of life in patients with metastatic breast cancer who strongly express HER2-positive disease.1 In this new study, HERA investigators will assess improvements in disease-free survival at an earlier stage of the disease.

Dr. Martine Piccart, Chair of BIG and Head of the Chemotherapy Department at the Jules Bordet Institute in Brussels, commented on the study, "HERA is one of the most challenging studies ever carried out in the treatment of breast cancer and therefore its results will be of great significance to the way in which patients are treated in the future. We hope that positive results will mean a greater number of patients will be able to take advantage of the benefits associated with Herceptin treatment."

In patients randomised to receive Herceptin, the treatment will be given sequentially after completion of established chemotherapy and, if indicated, radiotherapy, following surgery. Patients recruited for the study must have had definitive breast cancer surgery, completed their chemotherapy and have HER2-positive disease.

Herceptin is the first oncogene-targeted treatment for metastatic breast cancer with proven survival benefit. It is a monoclonal antibody designed to target specific cancer cells in the human body. Herceptin targets the abnormal cancer cells and blocks the function of HER2. A high level of HER2 can result in the uncontrollable growth of breast cancer cells. Approximately one in five patients with metastatic breast cancer are estimated to have HER2-positive disease (i.e. have high levels of HER2).

Eight to nine percent of women will develop breast cancer during their lifetime, making it one of the most common types of cancer in women.2 Each year, more than 250,000 new cases of breast cancer are diagnosed in Europe and approximately 175,000 in the United States.2 According to the World Health Organisation, an estimated 1.2 million women will be diagnosed with breast cancer worldwide, and more than 700,000 will die from the disease this year.2 Breast cancer is the primary cause of cancer-related deaths in women and the third-leading cause overall in the United States and Europe, with more than 165,000 patients in Europe and 44,000 in the United States dying from the disease.2

Notes to Editors
1. NEJM results summary1 -- A total of 469 patients were enrolled from 119 sites between June 1995 and March 1997. Patients were evenly distributed between the Herceptin (trastuzumab) plus chemotherapy and chemotherapy alone groups. When compared to chemotherapy, the addition of Herceptin (trastuzumab) to chemotherapy significantly prolonged median time to disease progression (7.6 versus 4.6 months), increased median duration of response (9.3 versus 5.9 months) and increased overall survival (25.1 versus 20.3 months). In general, Herceptin was well tolerated and adverse events were usually of mild to moderate severity.

2. Due to the proven clinical benefits Herceptin can offer patients with HER2-positive disease, Herceptin is now recommended within the EU for the treatment of women with high levels of HER2. It should only be used in those patients whose tumours have specifically been diagnosed as HER2-positive. Clinical trials have shown that careful selection of patients with HER2-positive disease results in superior efficacy from Herceptin treatment.

3. Studies have shown Herceptin, added to chemotherapy, extends survival for those who were strongly HER2-positive when compared to standard chemotherapy use alone. As a result of this dramatic improvement in patients with HER2-positive disease, it is essential that patients are tested to see if they could receive similar benefits from Herceptin treatment.

4. Herceptin is now approved in more than 60 countries throughout the world for the treatment of metastatic breast cancer.

5. Herceptin was discovered and developed by Genentech, a leading US biotechnology company in which Roche holds a 58 percent stake. In July 1998, Genentech granted Roche exclusive marketing rights for Herceptin outside the USA.

6. About Roche - Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of diseases, thus enhancing well-being and quality of life.
-end-
Roche is a world leader in oncology. Its franchise includes Xeloda (colorectal cancer, breast cancer), Herceptin (breast cancer), MabThera (non-Hodgkin's lymphoma), NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma), Neupogen (neutropenia) and Kytril (chemotherapy and radiotherapy-induced nausea).

Roche Oncology has four research sites (two in the US, Germany and Japan) and four HQ Development sites (two in the US, UK and Switzerland) dedicated to Oncology.

References:

1. Slamon DJ, Leyland-Jones B, Shak S et al. New England Journal of Medicine 2001; 344: 783 - 792. 2. World Health Organisation, 2000.

For further information please visit www.her2status.com or contact:

Carrie Deverell
Roche
Tel: +41 61 688 9848
Mobile: +41 795 069 940
E-mail: carrie.deverell@roche.com

Carrie Monaghan
Ketchum
Tel: +44 20 7611 3613
Mobile: +44 7884 265 413
E-mail: carrie.monaghan@ketchum.com

Rina Amin
Ketchum
Tel: +44 20 7611 3513
Mobile: +44 7770 794 235
E-mail: rina.amin@ketchum.com

Sally Cresswell
Ketchum
Tel: +44 20 7611 3554
E-mail: sally.cresswell@ketchum.com

Ketchum UK

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