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Investor Update

Basel, 31 May 2008

Second phase III study of Avastin plus chemotherapy shows improved progression-free survival in women with advanced HER2-negative breast cancer
Positive AVADO results support efficacy and safety of Avastin in first-line metastatic breast cancer

Roche today announced that Avastin® (bevacizumab), in combination with docetaxel chemotherapy, significantly increased the time women with metastatic breast cancer receiving first-line therapy lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS).  In this placebo-controlled Phase III trial (AVADO), two dose levels of Avastin in combination with docetaxel chemotherapy showed a statistically significant improvement in PFS compared to docetaxel chemotherapy alone, according to an investigator-assessed analysis. No new safety signals for Avastin were observed in the study.

The results were featured today during a press briefing at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“These results build upon previous data and expand our understanding of Avastin’s efficacy and safety when combined with another commonly used taxane chemotherapy,” said Dr. David Miles, principal investigator of the study.  “Importantly, this study supports that Avastin can be used with taxane-based chemotherapy to provide a meaningful benefit for patients with advanced HER2-negative breast cancer.”

Avastin combined with chemotherapy improved PFS by up to 64 percent (hazard ratio of 0.61; p=0.0001) in the 15 mg/kg treatment arm and by up to 45 percent (hazard ratio of 0.69; p=0.0035) in the 7.5 mg/kg treatment arm, compared to chemotherapy alone. Up to two thirds of patients (63%) experienced major shrinkage of their tumor, which is unprecedented (p=0.0001). After one year, 83 percent and 78 percent of patients were alive in the 15mg/kg and 7.5 mg/kg Avastin treatment arms, compared to 73 percent of patients receiving chemotherapy alone.

“The positive results of the AVADO study are encouraging news for patients suffering from metastatic breast cancer and confirm Avastin’s benefits as a treatment against this devastating disease” said William M. Burns, CEO Pharmaceuticals Division of Roche. “With our Avastin development program – the biggest trial program in oncology ever – we will continue to develop the best possible treatment approaches to increase survival and improve quality of life of cancer patients.”

This second large phase III trial follows the recently published E2100 study. Results from E2100 formed the basis of European Commission approval and FDA accelerated approval of Avastin in combination with the widely used chemotherapy paclitaxel for the first-line treatment of metastatic (HER-2 negative) breast cancer in March 2007 and February 2008 respectively. Study E2100 showed that the addition of Avastin to paclitaxel doubled patients’ chance of being alive without disease progression compared to paclitaxel alone.

Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally.

About the AVADO study
AVADO was an international, multicenter, randomized, double-blind, placebo-controlled clinical trial that enrolled 736 patients with locally recurrent or metastatic HER2-negative breast cancer who had not received chemotherapy for their metastatic disease.  Patients were randomized to one of two doses of Avastin (15 mg/kg or 7.5 mg/kg) or placebo given every three weeks in combination with docetaxel chemotherapy for a maximum of nine cycles.  Patients discontinuing docetaxel for toxicity or after nine cycles were to continue on Avastin only or placebo until disease progression.  The AVADO study was not designed to compare the two dose levels of Avastin.

In the 15 mg/kg and 7.5 mg/kg Avastin treatment arms, the 64 percent and 45 percent improvements in PFS observed can also be referred to as 39 percent and 31 percent reductions in the risk of cancer progression or death.  Median PFS was 8.8 months, 8.7 months and 8.0 months in the 15 mg/kg and 7.5 mg/kg Avastin plus chemotherapy arms and the chemotherapy alone arm, respectively.  Overall response rates were 63 percent (p=0.0001) and 55 percent (p=0.0295) in the 15 mg/kg and 7.5 mg/kg Avastin plus chemotherapy arms, compared to 44 percent in the chemotherapy alone arm.

The study protocol specified analyses for overall survival at the time of primary endpoint analysis and 24 months after the last patient was enrolled.  The final analysis for overall survival is expected in 2009.  Hazard ratios for the preliminary analysis of overall survival are 0.68 and 0.92 for the 15 mg/kg and 7.5 mg/kg Avastin arms, respectively. These initial results for overall survival are  based on early information.

No new safety signals related to Avastin were observed. Furthermore, Avastin did not have a major impact on the known toxicity profile of docetaxel.


About Avastin
Avastin directly inhibits vascular endothelial growth factor (VEGF), a key mediator of angiogenesis (the growth of new blood vessels). Blocking tumor angiogenesis with Avastin starves the tumor of the blood supply that is critical for its growth and spread throughout the body (metastasis). Because Avastin directly blocks tumor angiogenesis, a process common to all types of tumor development, it has the potential to deliver patient survival benefits in a variety of different cancer types. Roche is therefore pursuing a comprehensive clinical trial program investigating the use of Avastin in over 20 tumor types and different settings (advanced, post surgical). The total development program is expected to include over 40,000 patients world-wide and has already resulted in approvals in advanced colorectal, breast, lung, and kidney cancer.

  • February 2004 (US) and January 2005 (EU) – first-line treatment in patients with metastatic colorectal cancer (CRC)
  • June 2006 (US) – second-line treatment in patients with metastatic CRC
  • October 2006 (US) and August 2007 (EU) – first-line treatment in patients with advanced non-small cell lung cancer
  • March 2007 (EU) – first-line treatment in patients with metastatic breast cancer (BC)
  • April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
  • December 2007 (EU) – first-line treatment in patients with advanced renal cell cancer
  • January 2008 (EU) – first and later-line treatment in patients with metastatic CRC in combination with any chemotherapy
  • February 2008 (US) - first line treatment in patients with HER-2 negative metastatic BC

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 the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.com.

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