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Media Release
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
Basel, December 18, 2007. 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 care*. Kidney cancer, known
as renal cell carcinoma (RCC) is a disease that kills over 100,000 people per year world-wide1.
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 types2.
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.
“The results of the AVOREN study confirmed that Avastin is a safe, effective and well tolerated
treatment option for patients with advanced renal cell cancer,” said Professor Bernard Escudier,
Head of the Immunotherapy and Innovative Therapy Unit, Institut Gustave-Roussy, Paris, France
and Principal Investigator of the pivotal AVOREN study. “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 are still limited”
*
The approval is for the use of Avastin in patients with advanced and/or metastatic RCC in combination with IFN.
CH-4070 Basel
International Communications Manager Tel. +41 61 688 2164
F. Hoffmann-La Roche Ltd.
Erica Bersin
http://www.roche.com
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.
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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 age1.
As the most common type of kidney cancer, RCC accounts for approximately nine out of ten
cases of the disease3. 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%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 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.
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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.
Additional information
- Roche in Oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
- Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs
- Avastin: www.avastin-info.com
To access video clips about Avastin in broadcast standard free of charge, please go to:
www.thenewsmarket.com.
For more information please contact
Roche
Erica Bersin
+41.61.688.2164 (direct)
+41.79.618.7672 (mobile)
Galliard Healthcare
Jon Harris
+44.20.7663.2261 (direct)
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Parkin DM, Bray F, Ferlay J and Pisani P. Global cancer statistics 2002. CA Cancer J Clin, 2005; 55:
74-108.
De Mulder, PHM. Targeted therapy in metastatic renal cell carcinoma. Ann Oncol, 2007; 18
(Supplement 9): ix98–ix102.
Karumanchi, SA, et al. Renal cancer: molecular mechanisms and newer therapeutic options. Curr Opin
Nephrol Hypertens, 2002; 11: 37-42.
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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