Roche files Herceptin plus hormonal therapy for advanced HER2-positive breast cancer with European Authorities

Basel, 13 October 2006 - Roche announced today the submission of a Marketing Authorisation to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as treatment for advanced HER2-positive and hormone receptor-positive breast cancer. The application is based on data from the international TAnDEM study which showed that the addition of Herceptin to hormonal therapy doubles the median progression-free survival (amount of time a patient’s cancer is kept under control), from 2. 4 months to 4.8 months.1

HER2-positive breast cancer, which affects 20 to 30 percent of women with breast cancer, is an aggressive form of the disease that requires special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse.2 Up to a half of HER2-positive breast cancers are also hormone receptor-positive, a form of the disease that has typically been considered ‘lower-risk,’ due to successful treatment with hormonal therapies.3 However, TAnDEM is the first randomised study to show that this specific subset of ‘co-positive’ patients (both HER2- and hormone receptor positive) is actually ‘higher-risk’, making the positive results with Herceptin even more meaningful.

“The results from the TAnDEM study show once again that Herceptin should be the backbone for all HER2-positive breast cancer patients – it consistently benefits patients regardless of whether it is given in the early- or advanced-stage settings, or whether it is in combination with chemotherapy, hormonal therapy, or as a single agent,” said Eduard Holdener, Global Head of Roche Pharma Development. “This combination offers a new treatment regimen for patients who suffer from a particularly aggressive form of breast cancer, and we are pleased to have been able to progress this application so quickly.”

About the study
TAnDEM, conducted by Roche, is a randomised, phase III trial, which evaluated Herceptin in combination with the hormonal therapy anastrozole versus anastrozole alone as first-line therapy (or second-line hormonal therapy) in postmenopausal women with advanced (metastatic), HER2-positive and hormone receptor-positive (ER-positive and/or PR-positive) breast cancer. Enrolment to the trial began in 2001, and 208 HER2 and hormone receptor co-positive patients were randomized at 77 centres in 22 countries across the world.

Median progression-free survival, the primary endpoint of the trial, was 4.8 months for patients who received the combination compared to 2.4 months for patients who received hormonal therapy alone (p = 0.0016). Patients in the combination arm also responded significantly better to treatment (overall response rate was 20.3% versus 6.8%; p = 0.018). There was also a positive trend in median overall survival (28.5 months versus 23.9 months; p = 0.325); this is despite the fact that in the hormonal therapy alone arm, more than half of patients (58/104) crossed over to receive Herceptin during the trial when their disease had progressed, and an additional 15 (out of 104) patients received Herceptin at a later time point.

Overall safety data in both arms of the trial were acceptable given the known safety profile of each of the drugs in the advanced breast cancer setting. Patients in this study will continue to be followed for any side-effects.

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.4 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 percent 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. 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 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.

To date, over 310,000 patients with HER2-positive breast cancer have been treated with Herceptin 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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, while the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 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 (www.roche.com).

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References
1 Kaufman, B. Trastuzumab plus anastrozole prolongs progression-free survival in postmenopausal women with HER2 positive, hormone-dependent metastatic breast cancer (MBC). European Society for Medical Oncology (ESMO) Congress, Abstract no. LBA2, 2006
2 Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
3 Marty M, Cognetti F, Maraninchi D, et al. Efficacy and Safety of Trastuzumab Combined with Docetaxel in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Administered as First-Line Treatment: Results of a Randomised Phase II Trial by the M77001 Study Group. J Clin Oncol. 2005;23:4265-4274
4 World Health Organization, 2000.

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Katja Prowald

Head R&D Communications

Roche Group

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