Second Phase III Study of Avastin in 1st Line Metastatic Breast Cancer Meets its Primary Endpoint



    BASEL, Switzerland, Feb. 13 /CNW/ - Results of This Trial Further Confirm
the Benefit Avastin Brings to Patients With Breast Cancer.
    Roche announced today that a phase III study in metastatic breast cancer
investigating Avastin (bevacizumab) in combination with docetaxel chemotherapy
compared to docetaxel alone, met its primary endpoint of improving the time
patients live without their disease advancing.
    The findings come from the first analysis of the phase III "Avastin and
Docetaxel" ("AVADO", BO17708) study which investigated the addition of
docetaxel to Avastin administered either at 7.5 or 15 mg/kg every 3 weeks.
Both doses of Avastin in combination with chemotherapy showed statistically
significant improvements in the time patients live without their disease
advancing, as measured by progression-free survival, compared to chemotherapy
alone. The study was not designed to compare the two Avastin-containing arms.
    No new safety signals related to Avastin were observed in the trial.
    Dr David Miles, medical oncologist, Mount Vernon Hospital, UK and
principal investigator of AVADO, welcomed the news: "Each year more than one
million women are diagnosed with breast cancer leading to over 400,000 deaths
globally. This study confirms Avastin's effect of prolonging the time in which
patients live without their disease getting worse in combination with a widely
used chemotherapy partner - this time gained is very precious."
    The efficacy and safety data of AVADO will be presented at an upcoming
medical meeting.
    This second positive phase III trial follows the recently published
landmark E2100 study, which formed the basis of European Commission approval
of Avastin in combination with paclitaxel for the 1st line treatment of
metastatic breast cancer in March 2007. Study E2100 showed that the addition
of Avastin to paclitaxel resulted in a doubling of progression-free survival
compared to paclitaxel alone.

    About the BO17708 study

    BO17708 is an international phase III trial which randomized 736 patients
who did not receive previous chemotherapy for their metastatic breast cancer
to one of three groups;

    
    -  Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel
    -  Avastin 15 mg/kg every 3 weeks in combination with docetaxel
    -  docetaxel + placebo 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 overall
survival, response rate, duration of response, quality of life, safety and
tolerability.

    About Avastin

    Data from the comprehensive Avastin cancer clinical development programme
have resulted in approvals in advanced colorectal, breast, lung, and kidney
cancer:

    -  February 2004 (US) and January 2005 (EU) - first-line treatment in
       patients with metastatic colorectal cancer (CRC)
    -  June 2006 (US) - second-line treatment in patients with metastatic CRC
    -  October 2006 (US) - first-line treatment in patients with advanced
       non-small cell lung cancer (NSCLC)
    -  March 2007 (EU) - first-line treatment in patients with metastatic
       breast cancer
    -  April 2007 (Japan) - treatment in patients with recurrent or
       advanced CRC
    -  August 2007 (EU) - first-line treatment in patients with advanced
       NSCLC
    -  December 2007 (EU) - first-line treatment in patients with
       advanced RCC
    -  January 2008 (EU) - first and later-line treatment in patients with
       metastatic CRC in combination with any chemotherapy
    

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

    Additional information

    To access video clips about Avastin, in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com.





For further information:

For further information: Roche: Erica Bersin, +41-61-688-2164,
Erica.Bersin@Roche.com; Galliard Healthcare: Dominic Elliston,
+44-20-7663-2266, Delliston@galliardhealth.com

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