New Herceptin results confirm impressive reduction in risk of cancer returning

September 14, 2005

New Herceptin results confirm impressive reduction in risk of cancer returning in women with aggressive form of early-stage breast cancer

Fourth large phase III trial establishes and confirms Herceptin's superiority to chemotherapy alone

Roche announced today that a fourth large phase III trial in early-stage HER2-positive breast cancer has shown that adding Herceptin (trastuzumab) to chemotherapy significantly reduces the risk of cancer coming back compared to chemotherapy alone. This study follows three earlier phase III studies which also confirmed Herceptin's superiority to chemotherapy alone in early-stage breast cancer. HER2-positive breast cancer is a particularly aggressive form of the disease which affects approximately 20 - 30% of women with breast cancer.[a]

"The results from Herceptin's development programme in early breast cancer have been nothing less than remarkable, commented William M. Burns, CEO of Roche's Pharmaceuticals Division. "Four large trials in the past five months have delivered outstanding efficacy and safety from a vast patient pool and with a variety of treatment regimens, more than two years earlier than planned. Roche, the medical community and regulatory authorities around the world are urgently working together to secure access to Herceptin for early-stage HER2-positive breast cancer patients as soon as possible, and filing in Europe could happen as early as the beginning of 2006."

The interim analysis of the BCIRG 006 study shows that Herceptin combined with two chemotherapy regimens significantly reduced the risk of cancer coming back at an early stage for HER2-positive breast cancer patients. Findings from the three earlier trials showed that Herceptin impressively reduced the risk of cancer recurrence by about half. All in all, data from nearly 12,000 patients analysed now provide consistent evidence of Herceptin's effectiveness as adjuvant treatment for early-stage HER2-positive breast cancer, regardless of when or to which type of chemotherapy regimen it is added.

About the BCIRG 006 Study

Enrolment to the BCIRG 006 trial began in March 2001 and approximately 3,200 patients have been enrolled in 43 countries. The study was a randomised, controlled trial that evaluated the combination of doxorubicin and cyclophosphamide (AC) followed by docetaxel, with or without Herceptin, and carboplatin plus docetaxel and Herceptin (TCH), in women with early-stage HER2-positive breast cancer. Both lymph node-positive and lymph node-negative patients were eligible for entry into the trial.

The interim analysis met its primary efficacy endpoint by showing statistically significant improvements in disease-free survival (the length of time after treatment during which no disease is found) for both Herceptin-containing arms. According to the study sponsors, the reduction in the risk of disease recurrence versus chemotherapy alone was 51% in the arm adding Herceptin to docetaxel following AC, and 39% in the TCH arm. Although the secondary endpoint of overall survival had not yet been reached at the interim analysis, an improvement in overall survival is possible as the data mature.

The interim analysis compared each of the two Herceptin-containing arms versus chemotherapy alone and did not include a comparison of the two Herceptin-containing regimens. These data will become available in due time as the study matures.

The BCIRG 006 study has an external Independent Data Monitoring Committee (IDMC) that regularly reviews safety data. No safety concerns were raised by the IDMC. Clinically significant, yet rare, cardiac events were seen in 2.3% of patients who received AC chemotherapy followed by docetaxel and Herceptin, and in 1.2% of those who received carboplatin plus docetaxel and Herceptin, versus 1.2% of those who receive AC chemotherapy followed by docetaxel alone. Patients in this study will continue to be followed for any side effects.

The BCIRG 006 study is supported by sanofi-aventis and Genentech, and conducted by BCIRG, who will work to submit this data for presentation at the 2005 San Antonio Breast Cancer Symposium (SABCS), December 8 to 11, 2005.

About breast cancer and Herceptin

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.[b]

Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year.

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.

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. Herceptin has demonstrated improved survival in the advanced (metastatic) setting, where its addition to chemotherapy allows patients to live up to one-third longer than chemotherapy alone. Herceptin received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein. In addition to being indicated for use in combination with docetaxel as a first-line therapy in HER2-positive patients who have not received chemotherapy for their metastatic disease, it is also indicated as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in third-line therapy. 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 over 230,000 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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries 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 (

All trademarks used or mentioned in this release are legally protected.

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    References: a Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
    b World Health Organization, 2000

    Ketchum UK

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