New Data Confirms Avastin (R) as the Only Biologic to Demonstrate Overall Survival When Used First-Line in Metastatic Colorectal Cancer Patients With K-RAS (Wild-Type) Gene Status



    BASEL, SWITZERLAND, Sept. 16 /CNW/ - Avastin (bevacizumab) remains the
only biologic to provide overall survival (OS) benefit when used as first-line
treatment in combination with chemotherapy for patients with K-Ras wild type
metastatic colorectal cancer (mCRC). Avastin's strong position was confirmed
today following new data from a cetuximab (Erbitux) study presented at the
33rd Congress of the European Society for Medical Oncology (ESMO). "K-Ras
wild-type" describes the normal gene status seen in around 60% of colorectal
cancer patients where the K-Ras oncogene has not mutated.
    This confirmation of Avastin's survival benefit is important because
overall survival is of key importance for patients with advanced colorectal
cancer.
    The data presented came from a cetuximab study called the CRYSTAL trial
which showed that cetuximab in combination with chemotherapy failed to deliver
a significant overall survival benefit in either the general population or in
patients tested for K-Ras status. In contrast, an earlier analysis of Avastin
first-line in combination with chemotherapy achieved significant overall
survival for over two years (27.7 months) for patients with mCRC with K-Ras
wild-type. Avastin therefore remains the best treatment option for patients
with mCRC, regardless of oncogene mutations (e.g. K-Ras).
    "Extending the lives of my patients remains a key goal for me as a
treating physician," said Dr Mark Kozloff, Associate Professor, Department of
Oncology, University of Chicago, School of Medicine, US. "Avastin is the only
biologic in combination with chemotherapy which allows us to achieve this
essential outcome and should therefore be used first-line in the majority of
patients with metastatic colorectal cancer regardless of their K-Ras status."

    
    Main findings from CRYSTAL were:

    -   There was no statistical difference in overall survival (OS) in the
        K-Ras wild-type population - the study was negative for this
        secondary endpoint (24.9 vs. 21.0 months in the cetuximab and control
        arm respectively) (HR 0.84, p 0.22)

    -   There was no statistical difference in OS in the general study
        population - the study therefore failed to meet this key secondary
        endpoint (19.9 vs. 18.6 months in the cetuximab and control arm
        respectively) (HR 0.93, p 0.30)

    Main outcomes from pivotal Avastin 2107 study which demonstrated
    Avastin's superior K-Ras data:

    -   Avastin provides a statistically significant OS advantage in the
        K-Ras wild-type population (27.7 vs. 17.6 months in the Avastin and
        Control arm respectively) (HR 0.58, p 0.04)

    -   Avastin also provides statistically significant improvements in the
        time patients live without their disease worsening for both K-Ras
        wild-type (PFS improved by 82%, from 7.4 to 13.5 months, hazard
        ratio: 0.44, p(less than)0.0001) and K-Ras mutant patients (PFS
        improved by 69%, from 5.5 to 9.4 months, hazard ratio: 0.41,
        p=0.0008).

    -   Avastin provides a statistically significant gain in OS in the
        general population (20.3 vs. 15.6 months in the Avastin and control
        arm respectively) (HR 0.66, p(less than)0.001)

    -   The overall survival benefit of Avastin has been confirmed in two
        large community-based studies (First BEAT/BRiTE), including some
        4,000 patients

    In January 2008, Avastin received a broad label in the EU allowing it to
be used in combination with fluoropyrimidine-based chemotherapy for first and
later treatment lines in patients with mCRC. This means that virtually all
patients with metastatic colorectal cancer have access to Avastin's benefits.

    Additional information

    http://www.avastin-info.com
    http://www.Roche.com
    http://www.thenewsmarket.com (video clips about Avastin in broadcast
    standard, free of charge)
    





For further information:

For further information: please contact, Galliard Healthcare, Dominic
Elliston, +44-20-7663-2266, delliston@galliardhealth.com

Organization Profile

Roche

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890