Roche Pharmaceuticals

Xeloda Meets Primary Endpoint in Multinational Phase III Advanced Colorectal Cancer Study

    Basel, Switzerland (ots/PRNewswire) -

    - Roche to Approach World-Wide Regulatory Authorities for a New File Submission

    Roche announced today that a large, international Phase III study (NO16967) of 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival. Study results showed that the chemotherapy combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).

    "This data endorses previous findings that oral Xeloda in combination with oxaliplatin may provide a new treatment choice for colorectal cancer patients" said Eduard Holdener, Head of Global Development at Roche. " These data will be used in the submission to worldwide regulatory authorities to allow patients with colorectal cancer the opportunity to have an effective and more convenient therapy."

    Xeloda is an oral chemotherapy that can be taken at home and as such it has an important convenience benefit for both patients and doctors compared to intravenous infusions which require multiple hospital visits. This targeted cancer medicine is already used in previously untreated colorectal cancer patients and last year Xeloda received the additional approval for the treatment of early (adjuvant) colon cancer.

    Results from the NO16967 study will be submitted for presentation at future major medical meetings.

    "Our data complement the findings of the NO16966 study, suggesting that XELOX is a very reasonable treatment option for patients with recurrent colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor of Medicine at Vanderbilt University Medical Center and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer."

    In 2004, colorectal cancer was one of the leading cancers and accounted for 13 percent of all cancers.(1) It is estimated that more than 394,000 people die worldwide from colorectal cancer each year.(2)

    About the Study

    The NO16967 trial is a large, international phase III trial which randomized 627 patients from 15 countries world-wide who had previously received chemotherapy and whose disease had returned or continued to progress.

    The primary objective was to answer whether the XELOX regimen (Xeloda plus oxaliplatin) is as effective as FOLFOX 4 (intravenous bolus and infusional 5-fluorouracil/leucovorin plus oxaliplatin) in delaying disease progression or death. The secondary outcomes, to be reviewed included overall survival, overall response rates, and safety profile.

    About XELOX

    An abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.

    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 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 (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.

    Additional information

    - Roche in Oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

    - Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs

    References:

    1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Annals of Oncology 2005; 16:481-488

    2. Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology. BMJ 2000; 321:805-808

ots Originaltext: Roche Pharmaceuticals
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Contact:
Roche Group Media Office: Telephone: +41-61-688-8888 / Email:
basel.mediaoffice@roche.com - Baschi Dürr - Alexander Klauser -
Daniel Piller (Head Roche Group Media Office) - Katja Prowald (Head
Science Communications) - Martina Rupp



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