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Investor Update

Basel, 15 September 2008

Final analysis of Phase III trial confirms benefit of Avastin in Lung cancer

The final analysis of the pivotal phase III Roche-sponsored AVAiL (Avastin in lung) study in patients with previously untreated, advanced non-small cell lung cancer (NSCLC), presented today at the European Society of Medical Oncology (ESMO) in Stockholm confirmed that Avastin (bevacizumab) combined with gemcitabine-cisplatin chemotherapy offers a significant improvement by up to 30% in the time that patients live without their disease progressing (progression-free survival; PFS).  Tumour response rate was increased by up to 70% compared with chemotherapy alone.

Although the study was not powered to demonstrate an overall survival (OS) benefit, this measure was analysed as a secondary endpoint. All treatment groups in the study (i.e. with and without Avastin) demonstrated a median OS of more than 13 months, but as announced earlier, with no statistical difference for Avastin. The overall survival shown in this study is the longest survival reported when compared to other regimens used in similar patient groups.

Exploratory analysis of overall survival of patients without second-line therapies showed a trend towards improvement of survival in the combined Avastin groups (n=272 patients) as compared to chemotherapy alone (n=123 patients) from 7.3 months to 8.7 months (hazard ratio: 0.84, p-value: 0.20).

AVAiL is the second randomised phase III trial to demonstrate the significant clinical benefits of Avastin in NSCLC. Previously, the E4599 study, conducted in the US showed that adding Avastin to a different platinum based chemotherapy (carboplatin-paclitaxel) resulted in a significant improvement in overall survival, its primary endpoint, compared to chemotherapy alone.

“AVAiL confirms for the second time that Avastin provides important clinical benefits and the longest survival reported for patients with advanced non-squamous NSCLC.” said Professor Christian Manegold, Professor of Medicine at the Heidelberg University in Mannheim, Germany and Principal Investigator of the study.

Data from the E4599 and AVAiL studies formed the basis of Avastin’s European approval in lung cancer in August 2007 which meant, for the first time, patients could benefit from a treatment with proven ability to extend survival beyond one-year.

About AVAiL

The AVAiL study is a randomised, controlled, double-blind Phase III study that included more than 1,000 patients with previously untreated advanced NSCLC, the most common form of lung cancer, with histology other than squamous cell. In the AVAiL study patients received treatment with either Avastin at 7.5 mg/kg or 15 mg/kg + cisplatin-gemcitabine or placebo + cisplatin-gemcitabine.

The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms versus gemcitabine-cisplatin chemotherapy alone.

  • The results of the AVAiL trial showed that by adding Avastin to a cisplatin/gemcitabine regimen patients benefited from a significant increase in progression-free survival (PFS) over chemotherapy alone.   PFS was significantly prolonged by 20 to 30 % over chemotherapy alone (p-value: 0.003 for the 7.5 mg/kg Avastin group, 0.0456 for the 15 mg/kg Avastin group).
  • Tumour response rate was increased by up to 70% compared with chemotherapy alone (p-value: <0.0001 for the 7.5 mg/kg Avastin group, 0.0023 for the 15 mg/kg Avastin group).
  • There was a trend towards improvement of survival by adding Avastin, although it did not reach statistical significance. Median overall survival was as follows: 13.3 months in the placebo group, 13.6 months in the 7.5 mg/kg Avastin group, and 13.4 months in the 15 mg/kg Avastin group.

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 renal cell cancer.

  • February 2004 (US) and January 200(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 80,000 people. Additional information is available on the Internet at www.roche.com.

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