Investor Update
Basel, 29 March 2007
Avastin
approved in Europe for first line treatment of women with metastatic breast cancer
Breakthrough
therapy offers women the chance to live twice as long without their cancer progressing
Roche
today announced that their innovative cancer drug Avastin (bevacizumab) has been approved in Europe
for the treatment of women with metastatic breast cancer.
The European
Commission has approved Avastin for the first line treatment of women with metastatic breast cancer
in combination with a standard chemotherapy paclitaxel (originally branded Taxol). The approval is based
on pivotal Phase III trial data (E2100) which show that women with metastatic breast cancer have the
chance to live twice as long without their cancer progressing if treated with Avastin plus paclitaxel
compared to paclitaxel alone.
"Today’s approval represents a significant
advancement in breast cancer therapy,"said William M. Burns, CEO Division Roche Pharmaceuticals.
"We are proud to launch this significant new treatment option. We will now work to ensure that
Avastin is being made widely available to European physicians and patients with metastatic breast cancer
as quickly as possible."
David Cameron, medical oncologist, Lothian
University Hospitals NHS Trust and Clinical Lead for the South East Scotland Cancer Research Network,
welcomed the news: "It is devastating for a woman to be diagnosed with advanced breast cancer.
Despite
all the improvements in treatment that have already been made, the remarkable effect of Avastin in prolonging
the time to progression of metastatic breast cancer will be welcomed by patients - this time gained
is very precious."
Each year more than one million new cases of
breast
cancer are diagnosed worldwide, resulting in over 400,000 deaths per year. Metastatic breast cancer
is the number one cause of cancer death worldwide in women under the age of 551.
Avastin
is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall
and/or progression-free survival benefit for colorectal, lung, breast and renal cell cancer patients.
Additional
phase III trials are ongoing to explore Avastin in the first line treatment of metastatic breast cancer
in combination with docetaxel (AVADO) and other commonly used chemotherapies including Xeloda (RIBBON-1).
Recently, a phase III 1st line trial (AVEREL) in HER2-positive breast cancer evaluating Avastin in combination
with docetaxel plus Herceptin was initiated.
In Europe, Avastin was
approved in January 2005 and in the US in February 2004 for first-line treatment of patients with metastatic
colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for
patients with advanced colorectal cancer. Following priority review, the world’s first angiogenesis
inhibitor was approved by the FDA in October 2006 for the treatment of non-small cell lung cancer (NSCLC);
a filing for the same indication was submitted to EU authorities in August 2006. Most recently (in February
2007), a positive recommendation was received in Japan for the use of Avastin in patients with advanced
or recurrent colorectal cancer.
About the E2100 study
Study
E2100 was the first Phase III study set to evaluate Avastin in combination with paclitaxel versus paclitaxel
alone for the first-line treatment of patients with locally recurrent or metastatic breast cancer. This
randomised, controlled, multi-centre study enrolled 722 women. The study was sponsored by the National
Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers
led by the Eastern Cooperative Oncology Group (ECOG). The patients were randomised to receive treatment
with paclitaxel with or without Avastin. The trial was designed to give Avastin at a dose of 10mg/kg
every two weeks until disease progression. The results showed that patients receiving Avastin plus paclitaxel
had a median progression-free survival (PFS) of more than a year (13.3 months) while patients receiving
paclitaxel alone had a median PFS of approximately 7 (6.7 months) months. PFS is a measure of the time
patients live without their disease progressing. Overall in the trial, patients treated with Avastin
plus paclitaxel had a 52 percent reduction in the risk of disease progression or death, as expressed
by a hazard ratio of 0.48 (1-0.48=0.52 or 52%), which is also identical to doubling PFS (1/0.48= ~2).
Roche will submit OS data analysis during 2007 to EU regulatory authorities based on the all randomized
patient population with a still to be defined cut-off date.
Overall,
in the E2100 study, Avastin in combination with paclitaxel was generally well tolerated and had a favourable
safety profile in patients with locally recurrent or metastatic breast cancer at the recommended dose
of 10 mg/kg every two weeks.
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,
prostate 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 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 diagnostics and drugs for cancer and transplantation,
a market leader in virology and active in other major therapeutic areas such as autoimmune diseases,
inflammation, metabolism and 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
employs roughly 75,000 worldwide 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 at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Additional information:
- Genentech: www.gene.com
- Roche in Oncology
- Roche Health Kiosk on cancer
- Video clips, in broadcast standard, free of charge
1) Ferlay J, et al. Globocan 2002: Cancer incidence, mortality and prevalence worldwide, Version 2.0 (IARC, Cancerbase No. 5) Lyon, France, IARC Press, 2004