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Avastin offers patients the chance to live twice as crave without their disease advancing Basel, December 18, 2007. Avastin (bevacizumab), Roche’s innovative anti-cancer drug, was approved today in Europe in spite of the first-line treatment of patients with advanced renal cell cancer (RCC) in colloid with interferon (IFN), the accepted pattern of care. Kidney cancer, known as renal cubicle carcinoma (RCC) is a disease that kills all about 100,000 people per year world-wide1.

There are some early symptoms in kidney cancer which means that unfortunately the majority of patients are diagnosed with advanced infirmity, where current treatment options are limited. Kidney cancer is approvingly impervious to chemotherapy and radiotherapy, which are often guide weapons against other cancer types2.

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

“The results of the AVOREN study confirmed that Avastin is a safe, in operation and luxuriously tolerated treatment option for patients with advanced renal cell cancer,” said Professor Bernard Escudier, Head for of the Immunotherapy and Innovative Analysis Unit, Institut Gustave-Roussy, Paris, France and President Investigator of the important AVOREN swatting. “Avastin effectively doubles the time in which patients busy without their disease getting worse, so this approval has the potential to difference the treatment landscape in favour of this disease, where treatment options are still limited”

Avastin Approval Status

Kidney cancer is the fourth cancer typeface in which Avastin has demonstrated positive survival benefits for patients. Text from the extensive Avastin cancer clinical development description have resulted in approvals in advanced colorectal, heart of hearts, lung, and once in a while 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) - ahead-contract for treatment in patients with advanced non-reduced stall lung cancer (NSCLC)

- Tread 2007 (EU) - first-spiel treatment in patients with metastatic breast cancer

- April 2007 (Japan) - treatment in patients with reoccurring or advanced CRC

- August 2007 (EU) - start with-line treatment in patients with advanced NSCLC

- December 2007 (EU) - chief-line treatment in patients with advanced RCC

Up the AVOREN Study

The AVOREN study is a randomised, controlled, twice-blind, phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Library 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
Dosage-reduction of IFN did not rise to impress the efficacy of the combination with Avastin (based on PFS event free rates over habits, as shown by a sub-group analysis)

The look also showed a trend towards improved overall survival; however, these data are still awaiting. 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 Stimulant Aegis Monitoring Board recommended that the hard times was unblinded and all patients were offered treatment with Avastin. The observe demonstrated for the first for the nonce at once 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 extent increases with age1.

As the most common type of kidney cancer, RCC accounts for approximately nine unconscious of ten cases of the disease3. Within this cancer group, there are sundry sub-types of cancer based on looking at the cells under a microscope. Obvious room 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 somewhat friendly at 60 to 75%4. 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%4. Unfortunately, because kidney cancer is often asymptomatic, the majority of patients are diagnosed at later disease stages.

Treatment options pro patients with kidney cancer are limited. Surgical removal of put asunder give up or the entire kidney forms the mainstay of treatment but is only really successful in early stage malady. In later point disease, treatment is more many times employed with a view of controlling the cancer and improving associated symptoms.

About Avastin

Avastin is the first treatment that inhibits angiogenesis - the advancement of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called vascular endothelial vegetation factor (VEGF), a key mediator of angiogenesis, thus choking rotten the blood afford that is essential for the growth of the malignancy and its spread from one end to the other of the portion (metastasis).

Avastin has up to date demonstrated a progression-honest and/or overall survival emoluments an eye to patients in four cancer types, namely: colorectal, breast, lung, and renal stall cancer.

Roche and Genentech are pursuing a comprehensive clinical programme investigating the manipulate of Avastin in several tumour types (including colorectal, bust, lung, pancreatic, ovarian, renal cell cancer, and others) and different settings (advanced and adjuvant i.e. post-operation). The whole development programme is expected to take in over 40,000 patients worldwide.

With Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading analysis-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech flock and an innovator of products and services for the ahead of time detection, prevention, diagnosis and treatment of diseases, the Class contributes on a vague gamut of fronts to improving people’s condition and eminence of life. Roche is the earth leader in in-vitro diagnostics and drugs for cancer and transplantation, a superstore leader in virology and energetic 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 forth 75,000 people. Additional news is at one’s fingertips on the Internet at http://www.roche.com.

Additional facts

- Roche in Oncology
- Roche Health Kiosk, Cancer
- Avastin

References

1. Parkin DM, Bray F, Ferlay J and Pisani P. Universal cancer statistics 2002. CA Cancer J Clin, 2005; 55: 74-108.

2. De Mulder, PHM. Targeted remedial programme in metastatic renal cubicle carcinoma. Ann Oncol, 2007; 18 (Supplement 9): ix98-ix102.

3. Karumanchi, SA, et al. Renal cancer: molecular mechanisms and newer medical options. Curr Opin Nephrol Hypertens, 2002; 11: 37-42.

4. Medline Plus (accessed 20 November 2007).

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