Avastin(R) Shows Unprecedented Benefits in Colorectal Cancer Patients, Irrespective of K-Ras Gene Mutation



    BASEL, Switzerland, June 26 /CNW/ -

    - For Non-US Media Only

    - Avastin is the Only Biologic Proven to Extend Life in Patients With
    Normal K-Ras Gene

    Data presented today at the 10th World Congress on Gastrointestinal
Cancer (WCGC) in Barcelona confirm that Avastin (bevacizumab) significantly
improves survival in patients with metastatic colorectal cancer regardless of
whether they have mutation in a gene known as K-Ras. This outcome is important
because other biologic combinations have been found to be ineffective in
patients with a mutation in the K-Ras gene, which is found in up to half of
patients with colorectal cancer.

    Analyses of the randomized, controlled phase III AVF2107 study, showed
Avastin-based treatment resulted in:

    Unprecedented efficacy in patients with normal K-Ras gene (wild type)

    - a 82% increase in the time patients live without their disease getting
    worse (7.4 vs 13.5 months) vs chemotherapy alone

    - a 57% increase in overall survival (17.6 vs. 27.7 months) vs
    chemotherapy alone confirming that Avastin is the only biologic with
    proven survival benefit in this patient group

    - a significant increase in response rate; 60% compared to 37% in
    patients receiving chemotherapy alone

    Significantly enhanced efficacy in patients with K-Ras mutation

    - a 69% increase in the time patients live without their disease getting
    worse (5.5 vs 9.4 months) vs chemotherapy alone

    - these results show that Avastin-based therapy is the only biologic
    option with proven benefits for patients with K-Ras mutation

    "These data demonstrate that the addition of Avastin to standard
chemotherapy is active for patients with metastatic colorectal cancer with
both K-ras wild type and mutant tumours," commented Dr. Herbert Hurwitz, Duke
University in Durham, North Carolina, and principal investigator of AVF2107.
"The high response rate, PFS, and OS in the K-Ras wild type group are
impressive and confirm that Avastin should be part of the first line
management of patients irrespective of K-Ras status. On a practical level,
K-ras testing is not needed to initiate treatment with Avastin."
    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 metastatic colorectal cancer. This
means that virtually all patients with metastatic colorectal cancer have
access to Avastin's benefits.

    About AVF2107

    AVF2107 investigated the efficacy of Avastin in more than 800 previously
untreated metastatic colorectal cancer patients. In the study Avastin was
combined with a standard chemotherapy called irinotecan, fluorouracil and
leucovorin (IFL).
    The addition of Avastin to chemotherapy gave the most significant
improvement in survival time ever observed in a trial of advanced colorectal
cancer, significantly extending the duration of patient's life by 30%. The
results of AVF2107 formed the basis of Avastin's first approval in February
2004 (USA) and January 2005 (EU).
    In the AVF2107 analysis reported in Barcelona today, tumour tissue
samples were collected in a prospective manner to analyze the efficacy of
Avastin according to K-Ras status. Samples were available from 230 patients
(about one third of all patients treated in the study).

    About Avastin

    Roche is pursuing a comprehensive clinical trial program investigating
the use of Avastin in over 20 tumour types and different settings (advanced,
post surgical). The total development program is expected to include over
40,000 patients world-wide and has already 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) and August 2007 (EU) - first line treatment in
    patients with advanced non-small cell lung cancer

    - March 2007 (EU) - first line treatment in patients with metastatic
    breast cancer (BC)

    - April 2007 (Japan) - treatment in patients with recurrent or advanced
    CRC

    - December 2007 (EU) - first line treatment in patients with advanced
    renal cell cancer

    - January 2008 (EU) - first and later line treatment in patients with
    metastatic CRC in combination with any chemotherapy

    - February 2008 (US) - first line treatment in patients with HER-2
    negative metastatic BC

    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, +41-79-618-7672,
erica.bersin@Roche.com; Galliard Healthcare: Dominic Elliston,
+44-207-663-2266, delliston@galliardhealth.com

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