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2025'08.02.Sat
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2007'02.02.Fri
Largest Ever Data Set Shows Consistent Benefits With Avastin When Used in Combination With Different Chemotherapy Treatments
June 05, 2006

Real world practice confirms Avastin's efficacy and safety in advanced colorectal cancer
    BASEL, Switzerland, June 5 /Xinhua-PRNewswire/ -- New
data from 4,000 patients show that Avastin (bevacizumab
rhuMAb-VEGF) enables patients with advanced colorectal
cancer (CRC) to live longer without progression of their
disease.(1) The results also confirm that Avastin is well
tolerated.(2) The data, taken from two early access
programmes using Avastin in combination with a wide range
of chemotherapies, support findings of previous pivotal
trials, which demonstrated superior overall survival for
Avastin when added to chemotherapy.

    These data, which represent the largest data set on
Avastin available to date, were presented today at the 2006
American Society of Clinical Oncology (ASCO) Annual Meeting
in Atlanta, Georgia.

    The BEAT study, conducted in 41 countries across the
world, and the BRiTE registry, its US counterpart, are
investigating the use of Avastin in advanced CRC in
combination with standard chemotherapies including
oxaliplatin, irinotecan or 5-FU and/or Xeloda
(capecitabine). Outstanding progression-free survival
(length of time without the cancer growing) is seen in
BRiTE with a median at 10.2 months, independent of the
chemotherapy used.(1) This real life experience compares
favourably with the data previously seen in pivotal studies
of Avastin in CRC in which the addition of Avastin to
standard chemotherapies improved survival as well as
progression free survival, compared to chemotherapy alone.

    "In multiple large, well controlled studies,
Avastin has consistently demonstrated significant survival
benefits in colorectal cancer," said Dr. Mark Kozloff,
Clinical Associate, Department of Hematology/Oncology,
University of Chicago. "These new data are very
important as they confirm that the results shown in earlier
randomized trials hold true in the real world setting.
Moreover, they demonstrate that Avastin can be used in
combination with a wide range of chemotherapy treatments.
This is a real advance as it widens treatment options for
physicians and patients and bolsters their hope of
overcoming the disease."

    The BEAT and BRiTE studies also evaluate the safety of
Avastin with different chemotherapies in a broad patient
population. Results from the studies show that Avastin's
safety profile/tolerability is consistent with the safety
observations from other studies.

    In 2002, colorectal cancer was the third most commonly
reported cancer with approximately one million new cases
worldwide. It is estimated that over 50 percent of people
diagnosed with colorectal cancer will die of the disease
(3). In the European Union colorectal cancer is the second
most common cause of death from any cancer in both men and
women (4).

    Avastin is the first and only anti-angiogenic agent to
have demonstrated improved survival in the three major
causes of cancer death: colorectal cancer, NSCLC and breast
cancer. In Europe, Avastin was approved in early 2005 for
the first-line treatment of patients with metastatic
carcinoma of the colon or rectum in combination with
intravenous 5-fluorouracil/folinic acid or intravenous
5-fluorouracil/folinic acid/irinotecan. Avastin received
approval by the US Food and Drug Administration (FDA) and
was launched in the US in February 2004. In addition,
filing occurred in the US on April 10, 2006, for use of
Avastin in previously untreated advanced non-squamous,
non-small cell lung cancer and in Japan on April 21, 2006
for use of Avastin in patients with advanced or recurrent
colorectal cancer.

    About BEAT and BRiTE

    BEAT and BRiTE are two phase IV, open label,
multi-centre studies of patients with advanced CRC
receiving Avastin in addition to first-line chemotherapy.

    - BEAT is a phase IV trial which has enrolled 1927
patients from 41 countries worldwide. Patients are
receiving Avastin with chemotherapy; the most common
regimens are FOLFOX, CAPOX, FOLFIRI and Xeloda
(capecitabine). Efficacy data from the BEAT trial are
continuing to be evaluated. Safety data have shown that
Avastin related serious adverse events were reported in 9
percent of patients. Gastrointestinal perforation occurred
in 1.2 percent and bleeding in 1.3 percent.

    - BRiTE is a large, community based observational
registry which has enrolled 1968 patients across the US.
Patients are receiving Avastin with chemotherapy, the most
common regimens are FOLFOX, FOLFIRI and IFL. Current
efficacy data from the BRiTE study show a median
progression free survival of 10.2 months. Safety data have
reported that serious adverse events were seen in 12
percent of patients. Postoperative bleeding/wound healing
complications in 1.2 percent, gastrointestinal perforation
occurred in 1.7 percent, bleeding in 1.9 percent and
arterial thromboembolic events in 2.1 percent.

    About Avastin

    Avastin is the first treatment that inhibits
angiogenesis - the growth of a network of blood vessels
that supply nutrients and oxygen to cancerous tissues.
Avastin targets a naturally occurring protein called VEGF
(Vascular Endothelial Growth Factor), a key mediator of
angiogenesis, thus choking off the blood supply that is
essential for the growth of the tumour and its spread
throughout the body (metastasis).

    Roche and Genentech are pursuing a comprehensive
clinical programme investigating the use of Avastin in
various tumour types (including colorectal, breast, lung,
pancreatic cancer, ovarian cancer, renal cell carcinoma and
others) and different settings (advanced and adjuvant ie
post-operation). The total development programme is
expected to include over 25,000 patients worldwide.

    References:

    (1) Kozloff M, et al. Efficacy of bevacizumab plus
chemotherapy as first-line treatment of patients with
metastatic colorectal cancer: Updated results from a large
observational registry in the US (BRITE). Presented at ASCO
2006, abstract 3537

    (2) Berry S, et al. Preliminary safety of bevacizumab
with first-line Folfox, Capox, Folfiri and Capecitabine for
metastatic colorectal cancer - First B E A Trial. Presented
at ASCO 2006, abstract 3534

    (3) Parkin D et al. Global Cancer Statistics 2002.
Cancer J Clin 2005; 55: 74-108

    (4) Boyle P. Cancer incidence and mortality in Europe,
2004. Annals of Oncology 2005; 16(3): 481-488;
doi:10.1093/annonc/mdi098

    For further information please contact: Media Enquiries
- Onsite at ASCO - Christine Hill, Roche, Mobile:
+41(0)79-78-88-245; Nina Schwab-Hautzinger, Roche, Mobile:
+41(0)79-59-34-307; Sarah Winkless, Resolute
Communications, Mobile: +44(0)77-7175-7695; Tara Breen,
Resolute Communications, Telephone: +44(0)20-7357-8187,
Email: tara.breen@resolutecommunications.com

    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 a
supplier of innovative products and services for the early
detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of
medicines for cancer and transplantation and a market
leader in virology. In 2005 sales by the Pharmaceuticals
Division totalled 27.3 billion Swiss francs, and the
Diagnostics Division posted sales of 8.2 billion Swiss
francs. Roche employs roughly 70,000 people in 150
countries and has R&D agreements and strategic
alliances with numerous partners, including majority
ownership interests in Genentech and Chugai. Additional
information about the Roche Group is available on the
Internet ( http://www.roche.com ).

    All trademarks used or mentioned in this release are
protected by law.

    Additional information

    - Roche in Oncology: 
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

    - Roche Health Kiosk, Cancer: 
http://www.health-kiosk.ch/start_krebs

    For more information, please contact:

     Onsite at ASCO - Christine Hill
     Mobile: +41-0-79-78-88-245

     Nina Schwab-Hautzinger
     Mobile: +41-0-79-59-34-307

     Sarah Winkless
     Mobile: +44-0-77-7175-7695

     Tara Breen
     Tel:    +44-0-20-7357-8187
     Email:  tara.breen@resolutecommunications.com

SOURCE  Roche
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