European Regulator Gives Positive Opinion for the use of Avastin in Combination With docetaxel for the First-Line Treatment of Advanced Breast Cancer



    - For non-US, non-UK and non-Austrian Media

    BASEL, June 26 /CNW/ - Patients with advanced (metastatic) breast cancer
will be able to benefit from treatment with Avastin (bevacizumab) as a result
of a new broader label recommendation in Europe, Roche announced today. The
positive opinion issued by the European Committee for Medicinal Products for
Human Use (CHMP) is for the use of Avastin in combination with paclitaxel or
docetaxel chemotherapy for the first-line treatment of patients with
metastatic breast cancer.
    Avastin was granted European approval for use in combination with
paclitaxel in metastatic breast cancer in March 2007.
    The CHMP positive opinion is based on the results from the pivotal phase
III 'Avastin and Docetaxel' (AVADO) study. Based on the updated analysis the
combination of Avastin and docetaxel resulted in:

    
    -   Up to 49% increase in patient's chance of being alive without their
        disease progressing ('progression free survival') when treated with
        Avastin plus docetaxel compared to docetaxel alone.

    -   Over half the patients were alive without their disease progressing
        for more than 10 months when treated with Avastin plus docetaxel.

    -   In the 1-year survival analysis there were significantly more
        patients alive when treated with Avastin + docetaxel (84%) compared
        to docetaxel (76%).

    -   Overall survival data, reflecting ~ 45% of events, show no difference
        between the treatment arms.

    -   Up to two thirds of patients (64%) receiving Avastin based therapy
        experienced major shrinkage in their tumour.

    -   No new safety signals, confirming the safety and tolerability profile
        seen in previous studies.
    

    'This is the second, large phase III study to confirm that Avastin in
combination with a widely used taxane chemotherapy agent extends the time in
which patients live without disease progression,' said Principal investigator
for AVADO, Dr David Miles, medical oncologist, Mount Vernon Hospital, UK. 'The
CHMP opinion reflects the view that Avastin is an important part of the breast
cancer management strategy and gives us more flexibility when selecting the
treatment with our patients.'
    In addition, based on the results from AVADO the CHMP recommended that
the standard dose of Avastin for the treatment of metastatic breast cancer
remains at 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks.
    Despite the treatment improvements that have already been made, breast
cancer continues to be the leading cause of cancer death in women under age of
55 and more than one million women are diagnosed each year, this leading to
more than 500,000 deaths from the disease worldwide.(1),(2)
    In addition to breast cancer, Avastin is approved in Europe for the
treatment of the advanced stages of other three common types of cancer:
colorectal cancer, non-small cell lung cancer and kidney cancer. These types
of cancer collectively cause nearly 3 million deaths each year. In the US
Avastin is now approved for the treatment of four tumour types: breast,
colorectal, glioblastoma, and non-small cell lung cancer (NSCLC).

    About AVADO (BO17708)

    AVADO is an international phase III trial where 736 patients who did not
receive previous chemotherapy for their metastatic breast cancer were
randomised to one of three groups:

    
    -   Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel
        100 mg/m2

    -   Avastin 15 mg/kg every 3 weeks in combination with docetaxel
        100 mg/m2

    -   Placebo in combination with docetaxel 100 mg/m2 as control arm
    

    The primary objective of the study was to demonstrate superiority in
progression free survival of both Avastin containing treatment arms compared
to the control arm. Secondary endpoints for the study included response rate,
duration of response, time to treatment failure, overall survival, 1-year
survival, quality of life, safety and tolerability. Based on the updated
analysis the combination of Avastin and docetaxel resulted in:

    
    -   49% increase in a patient's chance of being alive without disease
        progression when Avastin was used at a dose of 15 mg/kg every 3 weeks
        compared to docetaxel alone.

    -   25% increase in a patient's chance of being alive without disease
        progression when Avastin was used at a dose of 7.5 mg/kg every 3
        weeks compared to docetaxel alone.

    -   Response rates (percentage of tumour shrinkage) were significantly
        increased only for the 15mg/kg every 3 week Avastin arm (46%
        (placebo) v 55% (7.5 mg/kg) and 64% (15 mg/kg)).

    -   Overall survival data, reflecting ~ 45% of events, show no difference
        between the treatment arms. The pre-specified landmark survival
        analysis at 1 year is significantly increased only for the 15 mg/kg
        every 3 week Avastin arm (76% (placebo) v 81% (7.5 mg/kg)) and 84%
        (15 mg/kg)).

    -   No new safety signals related to Avastin were observed. Furthermore,
        Avastin had only a limited impact on the known toxicity profile of
        docetaxel.
    

    About Avastin

    Avastin is an antibody that specifically binds and blocks VEGF (vascular
endothelial growth factor). VEGF is the key driver of tumour angiogenesis - an
essential process of development and maintenance of blood vessels which is
required for a tumour to grow and to spread (metastasise) to other parts of
the body. Avastin's precise mode of action helps control tumour growth and
metastases with only a limited impact on side effects of chemotherapy.
    Avastin has proven survival benefits across multiple tumour types.
Avastin is approved in Europe for the treatment of the advanced stages of four
common types of cancer: colorectal cancer, breast cancer, non-small cell lung
cancer and kidney cancer. These types of cancer collectively cause nearly 3
million deaths each year. In the US, Avastin was the first anti-angiogenesis
therapy approved by the FDA and is now approved for the treatment of four
tumour types: breast, colorectal, glioblastoma, and non-small cell lung cancer
(NSCLC).
    More than 500,000 patients have been treated with Avastin so far. A
comprehensive clinical programme with more than 450 clinical trials is
investigating the use of Avastin in various tumour types (including
colorectal, breast, lung, brain, gastric, ovarian, prostate and others) and
different settings (advanced or early stage disease).

    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, and is a market
leader in virology. It is also active in other major therapeutic areas such as
autoimmune diseases, inflammatory and metabolic disorders and diseases of the
central nervous system. In 2008 sales by the Pharmaceuticals Division totaled
36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7
billion francs. Roche has R&D agreements and strategic alliances with numerous
partners, including majority ownership interest in Chugai, and invested nearly
9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about
80,000 people. Additional information is available on the Internet at
http://www.roche.com.

    All trademarks used or mentioned in this release are legally protected.

    
    References

    (1) Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American
        Cancer Society, 2007.

    (2) WHO Cancer Factsheet No 297 - updated July 2008. Last accessed 24
        March 2009 at
        http://www.who.int/mediacentre/factsheets/fs297/en/index.html
    





For further information:

For further information: Amy Brice, Roche, +41-61-687-4054 or Jon
Harris, Galliard Healthcare, +44-207-663-2261

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