Healthcare Industry News:  Herceptin 

Biopharmaceuticals Oncology

 News Release - October 2, 2006

Patients With HER2-Positive Breast Cancer Significantly Benefit From Addition of Xeloda to Herceptin and Taxotere Therapy

New combination provides effective option for women with advanced stage of aggressive breast cancer

ISTANBUL, Turkey, Oct. 2 (Healthcare Sales & Marketing Network) -- New data presented today at the European Society for Medical Oncology (ESMO) show that the addition of Xeloda (capecitabine) to the combination of Herceptin (trastuzumab) and Taxotere (docetaxel) significantly increases the amount of time patients with HER2- positive advanced breast cancer have without their disease progressing. The median time to progression increased significantly from 13.8 to 18.2 months (p-value (equal sign) 0.045).

HER2-positive breast cancer, which affects approximately 20-30 percent(1) of women with breast cancer, demands immediate attention because the tumours are fast-growing and there is a high likelihood of relapse. These results provide the first evidence that adding a third chemotherapy to the most commonly used first-line regimen of Herceptin and taxanes provides a considerable extra benefit for patients with a particularly aggressive form of the disease. The drug combination was also generally well tolerated.

"Patients with advanced stage HER2-positive breast cancer often have a poor prognosis as their type of cancer does not always respond well to standard chemotherapy regimens," said Dr Andrew Wardley, lead investigator of the study and Consultant Medical Oncologist Hospital from Christie Hospital in the UK. "We need to continue to assess the potential benefits of new treatments and treatment combination therapies in order to find better options for patients. These results show encouraging signs for triple combination therapies, and further follow-up from this study and others will help us continue to explore their potential."

The study evaluated the addition of oral Xeloda to Herceptin and Taxotere in patients with HER2-positive breast cancer who were previously untreated for their locally advanced, or metastatic, disease. In addition to the significant results for time to progression (amount of time from randomisation until tumour growth) for patients on the triple combination, there was also a positive trend in progression-free survival (amount of time from randomisation until tumour growth or death) from a median of 12.8 to 14.8 months (p-value (equal sign) 0.060). For the primary endpoint of overall response rate (tumour shrinkage), patients in both arms achieved similarly high results of approximately 70%, with no statistical difference between the study groups (p-value (equal sign) 0.717). At the time of the analysis, overall survival results were immature due to short follow-up. Follow-up of this study is ongoing and final data analysis is expected in 2007.

Notes to editors:

About the CHAT study

222 patients were randomised into the phase II study: 112 received Xeloda plus Herceptin and Taxotere and 110 received Herceptin and Taxotere alone. Herceptin was administered at a dose of 6 mg/kg every 3 weeks until disease progression (after an initial loading dose of 8 mg/kg). Taxotere was administered at a dose of 100mg/m2 every 3 weeks with Herceptin alone, and 75mg/m2 when Xeloda was added, until disease progression. Xeloda was administered at a dose of 950 mg/m2 twice daily for the first 14 days of each 3-week cycle. Patients in the Herceptin and Taxotere alone arm of the study were given the option to cross over to receive Xeloda, following disease progression.

The CHAT study has an external Data Safety Monitoring Board (DSMB) that regularly reviews safety data. No unexpected safety concerns were raised by the DSMB, and the incidence of cardiac heart failure was low (one patient in each treatment arm).

About breast cancer

Breast cancer is the most common cancer among women worldwide.(2) Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually.(3)

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.

About Herceptin (trastuzumab)

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. Since 1998, Herceptin has been used to treat over 310,000 HER2-positive breast cancer patients worldwide.

About Xeloda (capecitabine)

Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada and has been shown to be an effective, safe, simple and convenient oral chemotherapy in treating over 1 million patients to date.

Roche received marketing authorisation for Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001. Xeloda has also been approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration (FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June 2005, respectively.

Xeloda is licensed in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following intravenous (i.v.) chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda recently received approval in South Korea for the first-line treatment of patients with locally advanced (metastatic) pancreatic cancer, in combination with gemcitabine. Xeloda is licensed for the first-line treatment of stomach cancer that has spread, in South Korea.

The most commonly reported adverse events with Xeloda include diarrhea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar erythrodysesthaesia).

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, and 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).

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

References:
    (1) Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
    (2) World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/
    (3) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004


Source: Roche

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