Roche Pharmaceuticals

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

    Basel (ots/PRNewswire) -

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

    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:

@@start.t1@@      - 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.@@end@@

    '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:

@@start.t2@@      - 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@@end@@

    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:

@@start.t3@@      - 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.@@end@@

    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

ots Originaltext: Roche Pharmaceuticals
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Contact:
For more information please contact: Amy Brice, Roche,
+41-61-687-4054 or Jon Harris, Galliard Healthcare, +44-207-663-2261



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