European Commission approves Herceptin + Taxotere as 1st-line therapy in HER2-positive breast cancer

June 22, 2004

Roche announced today that the European Commission has approved the use of Herceptin® (trastuzumab) in combination with Taxotere® (docetaxel) in the European Union as a first-line therapy in HER2-positive metastatic breast cancer patients who have not yet received chemotherapy for their disease. HER2-positive breast cancer patients suffer from a particularly aggressive form of breast cancer which traditionally has a poor prognosis.

The approval is based on study results(1) which showed that for women with HER2-positive breast cancer, the combination of Herceptin and Taxotere significantly improved median life expectancy by more than one-third (31 months with Herceptin plus Taxotere vs. 22 months for Taxotere alone). The study also showed that 61% of patients treated with the combination responded to treatment, compared to 34% of patients who received Taxotere alone.

"The early use of this new combination therapy represents a vital life-extending treatment option for patients, and highlights the critical importance of verifying HER2 status upon diagnosis of breast cancer," said William M. Burns, Head of Roche's Pharmaceuticals Division. "Now that this combination therapy will be made available to women across Europe, this further consolidates the position of Herceptin as the foundation of care in HER2-positive metastatic breast cancer."

In an earlier trial, Herceptin also showed a survival benefit when used as a first-line therapy in combination with Taxol® (paclitaxel). Both Taxol and Taxotere belong to the most commonly used class of chemotherapy agents for metastatic breast cancer in Europe, known as 'taxanes'. This trial with Herceptin and Taxotere firmly establishes Herceptin in combination with taxanes as the foundation of care for women with HER2-positive metastatic breast cancer.

The aggressive nature of HER2-positive breast cancer makes both the survival and response rates highly meaningful. In HER2-positive breast cancer, increased quantities of the HER2 (Human Epidermal growth factor Receptor 2) protein are present on the surface of the tumour cells. This is known as 'HER2 overexpression'. High levels of HER2 overexpression are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2 overexpression affects approximately 20-30% of women with breast cancer.
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Editor's Notes

About the study

188 patients were recruited into the study (M77001), 94 patients randomised to receive Herceptin plus Taxotere and 94 randomised to receive Taxotere alone. Two patients in the combination arm did not receive study drug and were excluded from the final analysis. Taxotere was scheduled at a dose of 100 mg/m2 every 3 weeks for at least 6 cycles. Herceptin was administered in 2mg/kg weekly doses until disease progression (after an initial loading dose of 4mg/kg). Patients in the Taxotere arm of the study were given the option to cross over to receive Herceptin, following disease progression.

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(2). 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.

Herceptin is a targeted humanised antibody treatment that 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 Taxotere 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 Taxol, and as a single agent in second- and third-line therapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche.

Roche in Oncology Within the last five years the Roche Group including its partners Genentech in the US and Chugai in Japan has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin's Lymphoma, and Avastin in Colorectal Carcinoma. In the United States Herceptin and Avastin are marketed by Genentech alone and MabThera/Rituxan by Genentech together with Biogen Idec Inc. Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these drugs.

The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. The Roche Group's cancer medicines generated sales of more than 6 billion Swiss francs in 2003.

In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer. Tarceva is being developed by Roche, Genentech and OSI Pharmaceuticals. Chugai is pursuing its development and regulatory approval for the Japanese market. Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

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

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

About Genentech

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Eighteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 12 biotechnology products directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For press releases and additional information about the company, please visit http://www.gene.com.

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

Please visit www.HER2status.com and www.heratrial.com for further information about Herceptin.

(1) M77001 12-month update results, presented at the European Breast Cancer Conference in March 2004

(2) World Health Organisation, 2000

Ketchum UK

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