HERA trial continues to demonstrate significant patient benefits from Herceptin

New 23-month follow-up data from HERA, one of the largest breast cancer trials ever carried out, show that Herceptin (trastuzumab) following standard chemotherapy significantly reduced the risk of death by 34% for women with early-stage HER2-positive breast cancer.

The data also show that Herceptin continues to provide patients with a reduced risk of their cancer coming back. HER2-positive breast cancer, which affects approximately 20% - 30% of women with breast cancer, demands special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse.

The data from the international HERA (HERceptin Adjuvant) study were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Atlanta, the biggest conference for oncologists worldwide. These follow-up data showed that Herceptin taken for 12 months increases the chance of long-term survival by preventing the development of advanced (metastatic) disease. Similar disease-free and overall survival benefits from Herceptin in this setting have also been seen in two large US trials, but the HERA study allowed for the use of a wide range of standard chemotherapy regimens before treatment with Herceptin, making these results highly meaningful to many parts of the world.

Professor Ian Smith, Head of the Breast Unit at Royal Marsden Hospital, London, UK, and investigator of the HERA study, commented, "These significant survival results for Herceptin in the early breast cancer are very important. Last year's HERA results showed that Herceptin could reduce the risk of recurrence; now we have confirmation for the first time that this means a better chance of staying alive. HER2-positive breast cancer is a more aggressive form of the disease, and it is very important that women diagnosed with early breast cancer have a HER2 test to see if they would benefit from Herceptin."

Roche filed for an indication of Herceptin in early-stage HER2-positive breast cancer in February 2006 based on the interim analysis of the 12-month arm of the HERA data. The European Commission granted approval for this indication on May 22, 2006.

The HERA study is a randomised, phase III trial, which evaluated the use of Herceptin versus observation following a wide range of primary chemotherapy (chemotherapy given before or after surgery) and radiotherapy (if applicable) for 12 or 24 months in women with early-stage HER2-positive breast cancer. The 23-month follow-up data show that patients who received Herceptin in the 12- month arm had statistically significant reductions in the risk of death (hazard ratio = 0.66), as well as the risk of cancer coming back (hazard ratio = 0.64).

The HERA study has an external Independent Data Monitoring Committee (IDMC) that regularly reviews safety data. No safety concerns were raised by the IDMC, and the incidence of severe congestive heart failure was very low (0.6% in the Herceptin arm vs. 0% in the observation arm). Patients in this study continue to be followed for any side effects.

HERA, conducted by the Roche and the Breast International Group (BIG), is one of the largest adjuvant studies ever carried out among breast cancer patients; enrolment to the trial began in December 2001, and nearly 5,100 HER2-positive patients were enrolled at 480 sites in 39 countries across the world. The HERA study allowed for the use of a wide range of chemotherapy regimens, and both lymph node-positive and lymph node-negative patients were eligible for entry into the trial.

The analysis of the 23-month follow-up compared Herceptin versus observation and did not include a comparison of 12 months versus 24 months treatment duration. The trial will continue to assess this comparison and data will become available in due time as the study matures.

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. 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. Research shows that HER2-positivity affects approximately 20-30% of women with breast cancer.

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. In addition to its efficacy in the early-stage breast cancer setting, Herceptin also 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 (advanced) breast cancer, whose tumours overexpress the HER2 protein. It is indicated for use as first-line therapy in combination with docetaxel in patients who have not received chemotherapy for their metastatic disease, first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, and third-line therapy as a single agent. As of May 2006, Herceptin is also approved in the European Union as adjuvant therapy following standard chemotherapy for early-stage HER2-positive breast 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 over 230,000 HER2-positive breast cancer patients worldwide.