New data from two large studies observing the routine use of Avastin-based therapy in more than 3,200 patients will be announced showing impressive treatment benefits in a non-selected patient population. Key findings included high rates of tumour shrinkage and overall survival beyond 2 years when Avastin is combined with the most common chemotherapy regimens. The data will be presented at the ASCO GI congress in Orlando (22 – 24 January 2010).

In a large, prospective German observational study, which included 1,620 patients, the average rate of tumour shrinkage (response rate) was 60 per cent for Avastin combined with chemotherapy. Successfully reducing the size of metastatic lesions may increase the chance of having them surgically removed, which could lead to long term survival or even a cure.

In the same German study, median overall survival exceeded 25 months. In the group of patients treated with oxaliplatin-based chemotherapy, the most commonly used chemotherapy in this setting, median overall survival was 27 months. Historically, median overall survival with chemotherapy alone did not exceed 20 months.

A similarly sized (1,658 patients) observational study carried out in the Czech Republic showed that elderly patients treated with Avastin combined with chemotherapy achieved similar results. Patients over the age of 65 years had a median survival time of 29.5 months. Patients under 65 years old had a similar median survival of 29.3 months.

“Since its introduction 5 years ago Avastin has changed the way metastatic colorectal cancer is treated and has become a standard of care”, said Niko Andre, Global Medical Director for Avastin. “These results confirm survival in routine practice can now exceed 2 years, which is great news for patients”.

In both studies Avastin’s established side effect profile was confirmed and no new safety signals were identified.

The German community-based study is a large prospective observational cohort study and included 1,620 eligible patients, between January 2005 and June 2008, with previously untreated metastatic colorectal cancer. Patients in the study received Avastin, every 2 weeks, with various standard first-line chemotherapy regimens, the choice of which was at the physicians’ discretion. The majority of chemotherapy regimens selected were oxaliplatin or irinotecan based. Patients were observed for up to 4 years after the initiation of treatment. Pre-defined efficacy endpoints were; response rate, PFS, and overall survival. Adverse events were recorded and assessed as potentially related to treatment or as severe.

The Czech study included 1,658 patients with previously untreated metastatic colorectal cancer who received Avastin, every 2 or 3 weeks, in combination with various chemotherapy regimens between October 2005 and October 2009. The study aimed to determine possible differences in efficacy and safety of Avastin between the age groups of <65 years and >65 years. In the study one-quarter of diagnosed patients were 65 years of age or older. Patients received Avastin combined with chemotherapy at the physicians’ discretion. The most common chemotherapy partners for Avastin were XELOX, FOLFOX and FOLFIRI with oxaliplatin-based regimens being the most frequent with more than 60 per cent.

Avastin is an antibody that specifically binds and blocks VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis – an essential process of development and maintenance of blood vessels which is required for a tumour to grow and to spread (metastasize) to other parts of the body. Avastin’s precise mode of action helps control tumour growth and metastases with only a limited impact on side effects of chemotherapy.

Avastin has proven survival benefits across multiple tumour types. Avastin is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer,non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause nearly 3 million deaths each year. In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and is now approved for the treatment of five tumour types: colorectal cancer, non-small cell lung cancer, breast cancer, glioblastoma, and renal cell carcinoma.

More than 500,000 patients have been treated with Avastin so far. A comprehensive clinical programme with over 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease).