Phase III study of Avastin in advanced stomach cancer did not meet primary endpoint

RocheRoche (SIX: RO, ROG; OTCQX: RHHBY) announced today the topline results from a global phase III trial investigating the use of Avastin (bevacizumab) in combination with Xeloda (capecitabine) or fluorouracil and cisplatin chemotherapy in patients with inoperable, advanced or metastatic gastric cancer (stomach cancer). The study, known as AVAGAST, did not meet its primary endpoint of extending overall survival in patients treated with Avastin in combination with chemotherapy compared to the same chemotherapy plus placebo.

The safety of Avastin in the study was consistent with previous trials across different types of cancer and no new safety signals were observed. Data from the study will be submitted for presentation at the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.

"We are disappointed with these results because treatment options for stomach cancer are limited. However, we look forward to sharing the data with the medical community, including secondary endpoints," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "We are committed to developing medicines for people with stomach cancer, including Herceptin and Xeloda."

These findings do not impact Avastin's approved indications such as advanced colorectal cancer, where Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment. Avastin's broad development programme in other tumour types will also continue as planned.

Approximately one million people are diagnosed each year with stomach cancer making it the fourth most common cancer and the second leading cause of cancer related death worldwide with an estimated 800,000 deaths caused by the disease.(1) The incidence of stomach cancer varies widely according to geographic region and is particularly common in Asia and South America. It is less common in North America and Europe. Advanced stomach cancer is associated with a poor prognosis; the median survival time after diagnosis is approximately 10 months with conventional chemotherapy.

About the AVAGAST study
AVAGAST is a multicentre, randomised, double-blinded, placebo-controlled phase III study designed to evaluate Avastin plus Xeloda or fluorouracil and cisplatin chemotherapy compared to Xeloda or fluorouracil and cisplatin chemotherapy alone in 774 patients with inoperable, locally advanced or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction, who have received no prior treatment for advanced or metastatic gastric cancer. Patients were randomised to receive either chemotherapy with placebo or chemotherapy with Avastin.

The primary endpoint of the study is overall survival. Secondary endpoints include progression free survival (PFS), time to progression (TTP), overall response rate, duration of response during first line therapy, disease control rate and safety.

About Avastin: Over 5 Years of Transforming Cancer Care
With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US for the treatment of patients with advanced brain cancer (glioblastoma). Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today - over half a million 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).

About Avastin: Mode of Action
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis - a fundamental process required for a tumour to grow and to spread (metastasise) to other parts of the body. Avastin's precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumour growth and extend survival with only a limited impact on the side effects of chemotherapy.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

1. Garcia M et al. Global cancer facts and figures 2007. Atlanta, GA: American Cancer Society, 2007.

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