Avastin approved in Europe for first-line treatment of patients with advanced kidney cancer

Avastin offers patients the chance to live twice as long without their disease advancing

Avastin (bevacizumab), Roche’s innovative anti-cancer drug, was approved today in Europe for the first-line treatment of patients with advanced renal cell cancer (RCC) in combination with interferon (IFN), the current standard of care1. Kidney cancer, known as renal cell carcinoma (RCC) is a disease that kills over 100,000 people per year world-
wide2.

There are few early symptoms in kidney cancer which means that unfortunately the majority of patients are diagnosed with advanced disease, where current treatment options are limited. Kidney cancer is highly resistant to chemotherapy and radiotherapy, which are often key weapons against other cancer types3.

The approval was based on data from the pivotal phase III AVOREN trial, which showed that patients with advanced RCC who received Avastin in combination with IFN lived nearly twice as long without their disease progressing (“progression free survival”), as those who received IFN alone.

“Today’s approval by European health authorities is a significant step forward in the treatment of advanced renal cell cancer. Avastin effectively doubles the time in which patients live without their disease getting worse, so this approval has the potential to change the treatment landscape for this disease, where treatment options have been limited” said William M. Burns, CEO of Roche’s Pharmaceutical Division.

Avastin Approval Status
Kidney cancer is the fourth cancer type in which Avastin has demonstrated positive survival benefits for patients. Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in advanced colorectal, breast, lung, and now 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) – first-line treatment in patients with advanced non-small cell lung cancer (NSCLC)
* March 2007 (EU) – first-line treatment in patients with metastatic breast cancer
* April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
* August 2007 (EU) – first-line treatment in patients with advanced NSCLC
* December 2007 (EU) – first-line treatment in patients with advanced RCC

About the AVOREN Study
The AVOREN study is a randomised, controlled, double-blind, phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Study participants received treatment with either Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in patients with advanced kidney cancer.

The results of the AVOREN trial showed that by adding Avastin to IFN:

* Progression free survival (PFS) was almost doubled from a median of 5.4 to 10.2 months
* Tumour response was significantly increased from 12.8% with IFN alone to 31.4% when Avastin was added
* Dose-reduction of IFN did not appear to affect the efficacy of the combination with Avastin (based on PFS event free rates over time, as shown by a sub-
group analysis)

The study also showed a trend towards improved overall survival; however, these data are still pending. No new or unexpected adverse events were observed.

An interim analysis of AVOREN was performed in December 2006 and the benefits provided by Avastin were so positive that the Drug Safety Monitoring Board recommended that the trial was unblinded and all patients were offered treatment with Avastin. The study demonstrated for the first time that Avastin benefits patients in combination with an immunotherapeutic, the class of drugs to which IFN belongs.

About Kidney Cancer
Kidney cancer is more common in men than women (approximately 62% of patients with kidney cancer are men) and incidence increases with age2.

As the most common type of kidney cancer, RCC accounts for approximately nine out of ten cases of the disease4. Within this cancer type, there are several sub-types of cancer based on looking at the cells under a microscope. Clear cell renal cell cancer is the most common type. If RCC is diagnosed at an early stage when the cancer is still confined to the kidney, the 5-year survival rates are relatively good at 60 to 75%5. However, if diagnosis is made at a later stage and the cancer has already spread to distant sites the 5-year survival rate is less than 5%5. Unfortunately, because kidney cancer is often asymptomatic, the majority of patients are diagnosed at later disease stages.

Treatment options for patients with kidney cancer are limited. Surgical removal of part or the entire kidney forms the mainstay of treatment but is only really successful in early stage disease. In later stage disease, treatment is more often employed with a view of controlling the cancer and improving associated symptoms.

About Avastin
Avastin is the first treatment that inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called vascular endothelial growth factor (VEGF), 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).

Avastin has now demonstrated a progression-free and/or overall survival benefit for patients in four cancer types, namely: colorectal, breast, 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, ovarian, renal cell cancer, and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.

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, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006, sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at www.roche.com.

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1. The approval is for the use of Avastin in patients with advanced and/or metastatic RCC in combination with IFN.
2. Parkin DM, Bray F, Ferlay J and Pisani P. Global cancer statistics 2002. CA Cancer J Clin, 2005; 55: 74-108.
3. De Mulder, PHM. Targeted therapy in metastatic renal cell carcinoma. Ann Oncol, 2007; 18 (Supplement 9): ix98–ix102.
4. Karumanchi, SA, et al. Renal cancer: molecular mechanisms and newer therapeutic options. Curr Opin Nephrol Hypertens, 2002; 11: 37-42.
5. Medline Plus http://www.nlm.nih.gov/medlineplus/ency/article/000516.htm#Causes,
%20incidence,%20and%20risk%20factors (accessed 20 November 2007).

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