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Roche Pharmaceuticals

Avastin(R) Significantly Prolongs Progression Free Survival in Patients With Advanced Lung Cancer

Chicago, Illinois (ots/PRNewswire)

- Only First-line Treatment to Demonstrate Extended Survival in
Over a Decade
Avastin (bevacizumab), significantly improves the time patients
with advanced non-small cell lung cancer (NSCLC) live without their
disease advancing ("progression free survival") when added to
cisplatin/gemcitabine chemotherapy, compared with chemotherapy alone.
NSCLC is the most common form of the disease and accounts for more
than 80 percent of all lung cancers(ii), with histology other than
squamous cell as the most common subtype accounting for approximately
60 percent of NSCLC cases. These findings were presented for the
first time, today at the 43rd annual meeting of the American Society
of Clinical Oncology (ASCO) in Chicago.
The results of the Avastin in Lung ("AVAiL", BO17704) trial showed
that by adding Avastin to a cisplatin/gemcitabine regimen:
- Progression free survival was significantly prolonged by 20
    to 30 % over chemotherapy alone
    - Tumour response rate was increased by up to 70% compared with
    chemotherapy alone
    - Duration of tumour response was increased from 4.7 to 6.1 months
    compared with chemotherapy alone
"Avastin is the only treatment in over a decade which has extended
survival for patients with previously untreated advanced NSCLC as
demonstrated by the pivotal E4599 trial. AVAiL now shows that Avastin
is also effective when administered with a different chemotherapy
regimen" said Professor Christian Manegold, Professor of Medicine,
Heidelberg University, University Medical Center, Mannheim, Germany
and Principal Investigator of the study. "Lung cancer is an extremely
difficult disease to treat and this will give real hope to many
patients."
Two doses of Avastin were investigated in the study (7.5 and 15
mg/kg) and both demonstrated similar benefits. No new or unexpected
adverse events were observed. Overall survival data are still pending
and will be presented at a future oncology conference.
Lung cancer accounts for 1 in 3 cancer related deaths in men and 1
in 4 in women. Worldwide, there are more than 1.2 million new cases
of lung and bronchial cancer diagnosed each year, (i) and new
treatment options are urgently needed as the disease has a very high
mortality rate.
About AVAiL
The AVAiL study is a randomised, controlled, double-blind Phase
III study that includes more than 1,000 patients with previously
untreated advanced NSCLC, the most common form of lung cancer, with
histology other than squamous cell. The primary objective of the
study was to demonstrate superiority in progression-free survival of
both Avastin containing treatment arms versus the control regimen.
In the AVAiL study patients received treatment with either Avastin
at 7.5mg/kg or 15mg/kg + cisplatin-gemcitabine or placebo +
cisplatin-gemcitabine and a similar treatment effect was observed
between the two arms.
About Lung Cancer
The majority of NSCLC cases are still diagnosed at an advanced
stage when the cancer is inoperable or has already spread to another
part of the body. In spite of the use of chemotherapy as the
first-line treatment option, less than five percent of people with
advanced NSCLC survive for five years after diagnosis and most die
within twelve months(i)(ii).
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).
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 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 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
    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
References
(i) Stewart BW and Kleihues P. World Cancer Report. IARC
Press, Lyon, pp.183-87, 2003
(ii) Wilking N and Jonsson B. A Pan-European comparison regarding
patient access to cancer drugs. Karolinska Institute in collaboration
with Stockholm School of Economics, Stockholm, Sweden, 2005.

Contact:

For more information please contact: Roche, Erica Bersin,
+41-61-688-2164 (direct), +41-79-618-7672 (mobile on-site at ASCO);
Galliard Healthcare, Jon Harris, +44-(0)207-663-2261 (direct)

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