Media Release

Basel, 12 December 2006

Avastin shows positive outcomes in patients with advanced kidney cancer
Exciting new results add to Avastin’s track record of success in patients with colorectal, lung and breast cancer

An interim analysis of a phase III study in advanced renal cell cancer has shown that Avastin significantly prolongs the time patients live without their disease progressing. In addition, this early analysis indicated a trend towards an improvement in overall survival. Renal cell cancer is the most common form of kidney cancer accounting for nine out of ten cases and treatment options are limited. Due to the benefits observed, the independent Drug Safety Monitoring Board (DSMB) has recommended that the study be unblinded and all patients will be offered treatment with Avastin. Safety was in line with what has been observed for Avastin in previous studies.

"The results have shown that Avastin works effectively as a first-line treatment for renal cell cancer. This is the fourth cancer type in which Avastin’s unique mode of action translates into a progression-free survival benefit for patients," said Eduard Holdener, Head of Roche Pharmaceuticals Development. "Current treatment options in advanced kidney cancer are limited and we are planning to work with health authorities in Europe to make Avastin available to patients with renal cell carcinoma as soon as possible."

In the AVOREN study patients received treatment with either Avastin and interferon alpha-2a or interferon alone, a standard of care in advanced kidney cancer. This is the first time that Avastin has demonstrated benefits for patients also in combination with an immunotherapeutic.

Further analyses of the AVOREN study are underway and results will be presented at an upcoming oncology conference.


About AVOREN
AVOREN is an international phase III trial which included 649 patients with advanced renal cell cancer. Patients were divided into two arms to receive either standard therapy of interferon alpha-2a or interferon alpha-2a plus Avastin. Avastin was administered every two weeks at a dose of 10mg/kg. The primary endpoint of the study was to demonstrate overall survival when Avastin was added to interferon alpha-2a therapy. The study protocol specified an interim overall survival analysis be performed at approximately 50 percent of events. Secondary endpoints included progression free survival (PFS), time to progression, time to treatment failure, overall response rate and safety profile.

In line with previous feedback from health authorities, Roche is planning to file Avastin in Renal Cell Carcinoma based on results from the AVOREN study. In the US, in prior consultation with the FDA, the primary analysis endpoint was revised to assess improvement in PFS, defined as the length of time the tumour did not grow or patient death did not occur.

About Kidney Cancer
On an annual basis in excess of 200,000 people will receive a diagnosis and more than 100,000 people will loose their lives to kidney cancer. This figure is expected to increase. Kidney cancer is more common in men than women (approximately 62% of renal cell carcinoma occurs in males) and incidence increases with age¹.  

Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for nine out of ten cases. 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 – 75%. 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%². 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. These treatments are of limited success and include interferon alpha and interleukin or less commonly chemotherapy or radiotherapy.

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 VEGF (Vascular Endothelial Growth Factor), 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).

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant ie 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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

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References
1 Parkin DM, Bray F, Ferlay J and Pisani P. Global cancer statistics 2002. CA Cancer J Clin 2005; 55; 74 – 108.
2 Medline Plus www.nlm.nih.gov/medlineplus/ency/article/000516.htm (accessed on 23rd October 2006)