Avastin's (bevacizumab) role in the treatment of patients with metastatic colorectal cancer (mCRC), the world's second most common cancer, was strengthened at the 33rd European Society of Medical Oncology (ESMO) meeting with a compelling data set including:

- the final overall survival analysis of a 2,000 patient community-based study
- further analyses of the bevacizumab and cetuximab combination study highlighting K-Ras Findings
- strong and consistent outcome for elderly patients on bevacizumab -based therapy

Long-term overall survival reported from First BEAT 1

The long term benefits of bevacizumab use in combination with chemotherapy were confirmed in the 1,965 patient First BEAT study, which combined bevacizumab with commonly used chemotherapies in mCRC. First BEAT data confirmed:

-Bevacizumab-based therapy delivers a median overall survival benefit of almost two years (22.7 months).

- Patients who received bevacizumab plus chemotherapy and underwent complete resection of their tumor had double the chance of surviving at 2 years compared to those who did not at 89% versus 44%, respectively.

- Importantly, long-term bevacizumab treatment did not increase the risk of patients suffering from bevacizumab -specific side effects, which were consistent with those reported in other clinical trials.

K-Ras findings from bevacizumab and cetuximab combination study to be presented 2

On September 14, key K-Ras findings will be presented at ESMO on bevacizumab-based treatment plus or minus cetuximab from the CAIRO-2 study. These findings are expected to compliment the recently reported data confirming that bevacizumab is the only biologic that significantly improves survival in patients with mCRC regardless of the patient's K-Ras gene mutation status.

- Specifically, the data showed that patients with the normal (wildtype) K-Ras gene had an 82% increase in the time they lived without their disease getting worse and a 57% improvement in overall survival when given bevacizumab and chemotherapy compared to chemotherapy alone.

- Similarly, bevacizumab -based therapy improved outcomes in patients with mutated K-Ras compared to chemotherapy alone by increasing the time patients live without their disease getting worse by 69% and extending life by 46%.

Avastin's survival benefit in mCRC is unmatched in patients with either normal or mutated K-Ras. Between 40 and 45% of patients will have a mutated form of K-Ras4, where many other treatments have been shown to provide no benefit.

Bevacizumab efficacy is unaffected by age 3

A new analysis of 4 key trials which included more than 3,000 patients showed that the benefits of bevacizumab-based therapy are independent of age. Considering that the majority of colorectal cancer patients are over 65 years in age, the magnitude of this finding becomes clear. The analysis demonstrated:

- Patients on bevacizumab-based therapy that were under 65 years old had a 70% increased chance of being alive without their disease advancing compared to those on chemotherapy alone. If the patient was 65 or older this chance increased slightly to 72%.

- Furthermore, these findings were not impacted by the physician's choice of chemotherapy to use with bevacizumab.

In January 2008, bevacizumab received a broad label in the EU allowing it to be used in combination with fluoropyrimidine-based chemotherapy for first and later treatment lines in patients with mCRC. This means that virtually all patients with metastatic colorectal cancer, without contraindications, could be eligible for bevacizumab's benefits.

Bevacizumab has a well-established tolerability profile and the most frequently observed drug reactions in clinical trials were hypertension, fatigue, neuropathy and proteinuria. Bevacizumab does not increase chemotherapy-related toxicities, and the most common side effects are generally manageable. For example, hypertension can be managed with conventional antihypertensive treatment.

About bevacizumab (Avastin)

Bevacizumab is the first licensed treatment that was specifically designed to inhibit angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. It 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).

Bevacizumab has now demonstrated a progression-free and/or overall survival benefit for patients in four types of metastatic/advanced cancer: colorectal, breast cancer, lung and renal cell cancer. 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 ie post-operation). The total development programme is expected to include over 40,000 patients worldwide.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Find out more at rocheuk

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