Basel, 2 November 2005

Xeloda now shown to extend survival for patients with pancreatic cancer

First Xeloda data to show survival benefit in this deadly cancer

The interim analysis of one of the largest phase III studies investigating the 1st line treatment of advanced pancreatic cancer shows that adding Xeloda (capecitabine) to standard chemotherapy (gemcitabine) significantly extends patient survival. The study showed that after a year, 1 patient out of 4 was still alive when treated with Xeloda plus standard chemotherapy compared to 1 in 5 taking standard chemotherapy alone. These remarkable findings were unveiled for the first time at the European Cancer Conference (ECCO) in Paris today.

“This encouraging Xeloda data provides further survival benefit and quality of life for patients with this deadly disease and very limited treatment options. The latest results come on top of the recent positive recommendation by the FDA for Tarceva in pancreatic cancer. In addition, Roche has initiated studies with Avastin in this disease”, commented William M. Burns, CEO Roche Pharma. “We have also filed Tarceva in pancreatic cancer in the European Union and other countries world-wide.”

Pancreatic cancer is one of the most aggressive forms of cancer and is the fifth leading cause of all cancer deaths in the developed world. Approximately 78,000 new cases of pancreatic cancer are diagnosed per year in Europe and 30,000 new cases in the US¹. Very few treatment options exist.

“These data are very exciting and give new hope for pancreatic cancer sufferers who in general have a very short life expectancy,” said Professor John Neoptolemos, Surgical Oncologist, Division of Surgery and Oncology, at the Royal Liverpool University Hospital. “Since the study began in May 2002, I have more patients who are still alive on the Xeloda combination after 12 months and longer - I have never seen so many patients achieve this before,” he added.

Lead investigator, Professor David Cunningham said, “This is the first time that adding another cytotoxic drug to gemcitabine has improved the outcome for patients with inoperable pancreatic cancer and the trial results are therefore an important milestone. The combination of gemcitabine and capecitabine should now be considered one of the standard options for patients with advanced pancreatic cancer.“

About the study
This randomised study, funded and designed by Cancer Research UK, compared the survival of gemcitabine with gemcitabine plus Xeloda and involved 533 previously untreated patients with locally advanced or metastatic pancreatic cancer. Patients receiving the combination therapy lived significantly longer than those with standard therapy alone (median survival 7.4 vs. 6 months, HR= 0.80) with acceptable levels of toxicity. A higher percentage of patients were alive at 12 months in the group treated with Xeloda plus gemcitabine, compared to those treated with chemotherapy alone (26% vs. 19%).

About Xeloda
Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada. 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 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 is licensed for the first-line treatment of stomach cancer that has spread, in South Korea.

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.

1  References: Ferlay j et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevelance Worldwide. IARC CancerBase No5, version 2.0, Lyon; IARC Press 2004

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Further Information
- Xeloda Factsheet
- Roche in Oncology