Xeloda filed in Europe for treatment of advanced stomach cancer

Oral cancer drug offers patients with stomach cancer a highly effective and safe treatment option compared to current standard therapy

Basel, 21 July 2006, The European Medicines Agency informed Roche today that the filing for a new indication in Europe for the oral cancer drug Xeloda (capecitabine) in combination with another chemotherapy (cisplatin) for the treatment of patients with advanced gastric (stomach) cancer has been accepted. Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide.1

The filing is based on results from the first-ever phase III study investigating the efficacy and safety of Xeloda/cisplatin compared to the current standard therapy of infusional 5-fluorouracil (5-FU) plus cisplatin as first-line treatment of the disease. The study results confirmed that patients receiving the Xeloda/cisplatin combination therapy lived at least as long without the cancer progressing as those treated with the current standard therapy. Furthermore, for the first time in any cancer, Xeloda/cisplatin response rate (percentage of patients whose cancer shrinks after treatment) was superior, when compared to infusional 5-FU. Xeloda greatly simplifies the treatment regimen due to its oral form, reducing the need for hospital visits and allowing patients more precious time to spend with family and friends.

“Today marks a significant milestone for Roche. We are setting in motion the necessary steps to make this new and effective treatment available for European patients fighting advanced stomach cancer – a particularly painful and debilitating form of cancer,” said Eduard Holdener, Head of Roche Pharmaceuticals Development.

“These new robust data are very encouraging – for the first time a viable alternative to the current standard intravenous treatment will become available for stomach cancer patients in Europe,” stated lead investigator Prof. Y. K. Kang of the Asan Medical Center, Seoul, South Korea.

In Europe alone, nearly 140,000 people die from stomach cancer each year.2 Stomach cancer affects twice as many men as women and occurs more frequently in people aged over 55 years.3 Amongst tumours of the upper gastrointestinal tract, oesophagogastric cancer is more common in the West, whilst stomach cancer is predominant in the East.4

About the ML17032 study
The study, conducted by Prof. Kang and his team, is a large international phase III study in advanced stomach cancer. Some key highlights from this remarkable study, ‘Randomised phase III trial of capecitabine/cisplatin vs. continuous infusion of 5-FU/cisplatin as first-line therapy in patients with advanced gastric cancer: efficacy and safety results’ include:
• This phase III study was conducted in 316 advanced gastric cancer patients who were enrolled in 46 centres across 13 countries in Asia, South America, and Eastern Europe.
• The study compared the efficacy and safety of the Xeloda plus cisplatin combination (XP) with the intravenous 5-FU plus cisplatin combination (FP); FP is a standard treatment for gastric cancer, and accepted by regulatory agencies as the reference regimen against which all other regimens should be compared.
• The primary endpoint was non-inferiority in progression-free survival; patients receiving the XP combination therapy lived at least as long without the cancer progressing as those treated with FP (median progression-free survival 5.6 vs. 5 months, HR= 0.81, p=<0.001, demonstrating non-inferiority),
• The level of toxicity was similar between the two treatment arms. Gastrointestinal adverse events were among the most frequent adverse events in both treatment groups with nausea and vomiting being the most predominant adverse events.
• XP patients also lived at least as long overall (10.5 vs. 9.3 months, HR=0.85, p=0.008, demonstrating non-inferiority).
• XP response rate based on investigator assessment was superior to FP – this is the first time that Xeloda has shown superiority to infusional 5-FU rather than bolus 5-FU (overall response rate 41 vs. 29 percent, p=0.030).
• XP reduces the amount of time a patient needs to visit the clinic by 80 percent compared to FP (1 day vs. 5 days per 3 weeks).

About Xeloda
Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada and has been shown to be 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 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 diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome.

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).

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References:
1. Ajani, J. Evolving Chemotherapy for Advanced Gastric Cancer. The Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-582.
2. Boyle, P & Ferlay, J. Cancer incidence and mortality in Europe. 2004. Annals of Oncology 2005; 16(3):481-4883.
3. Oncology Channel. www.oncologychannel.com/gastriccancer/. Visited on 15th March 2006
4. Crew, K & Neugut, A. Epidemiology of gastric cancer. World J Gastroenterol. 2006 Jan 21; 12(3):354-62

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Roche

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