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

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

June 04, 2007

-- Only First-line Treatment to Demonstrate Extended
Survival in Over a Decade


    CHICAGO, June 4 /Xinhua-PRNewswire/ --

    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:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf


    Roche Health Kiosk, Cancer
    http://www.health-kiosk.ch/start_krebs

    Avastin: http://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.


    For more information, please contact:

     Erica Bersin, Roche
     Tel:    [phone]
     Mobile: [phone] (on-site at ASCO)

     Jon Harris, Galliard Healthcare
     Tel:    [phone]