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Avastin and Xeloda meet primary endpoints in large Phase III first line metastatic colorectal cancer study


Basel, 31st July 2006, Roche announced today that a large, international Phase III study (NO16966) enrolling 2, 035 previously untreated metastatic colorectal patients met both primary endpoints.
Results of the study showed that:
• The chemotherapy combination Xeloda plus oxaliplatin, called XELOX is as effective in terms of progression-free survival (PFS) – a measure of the time patients live without their disease progressing – as infused 5-FU/leucovorin plus oxaliplatin, called FOLFOX;
• The addition of Avastin to chemotherapy (FOLFOX and XELOX) significantly improved progression-free survival compared to chemotherapy alone.
Some variability in treatment benefit was observed in subgroups. No new safety signals related to Avastin were observed in the trial.

“This is the first time that we have significant data showing that oral Xeloda in combination with oxaliplatin is as effective as FOLFOX, demonstrating that XELOX provides a new treatment option for colorectal cancer patients” said Ed Holdener, Head of Global Development at Roche. “These data again show the benefit of adding Avastin to chemotherapy. In this trial Avastin combined with FOLFOX and XELOX improved the chance of delaying progression of the disease by 20% in patients with metastatic colorectal cancer.”

Results from the study will be submitted to a future international cancer congress.

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 NO16966 trial is a large, international phase III trial which randomized 2,035 patients and compared as first line colorectal cancer treatment initially:
• XELOX (Xeloda plus oxaliplatin) vs FOLFOX (intravenous bolus and infusional 5-fluorouracil plus oxaliplatin)
After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate in a 2 by 2 factorial design:
• XELOX + placebo vs XELOX + Avastin (7.5 mg/kg q3w)vs FOLFOX + placebo vs FOLFOX + Avastin (5.0 mg/kg q2w).
The primary objectives were to answer two questions: firstly whether the XELOX regimen is non-inferior to FOLFOX and secondly whether the addition of Avastin to chemotherapy is superior to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, and safety profile.

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 Avastin (bevacizumab)
Avastin is the first treatment that inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

In Europe, Avastin was approved in January 2005 and in the US in February 2004 for the first-line treatment of patients with metastatic colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer. The first filing for Avastin in Japan occurred in April 2006 for the treatment of metastatic colorectal cancer. More recently, Avastin was filed for the treatment of women with metastatic breast cancer in the EU in July 2006, which followed the US May 2006 filing.

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.

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 (

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

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


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