Largest Ever Data Set Shows Consistent Benefits With Avastin When Used in Combination With Different Chemotherapy Treatments

Basel, Switzerland (ots/PRNewswire) -

- Real World Practice Confirms Avastin's Efficacy and Safety in
Advanced Colorectal Cancer

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

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 (www.roche.com).

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

Additional information

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

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

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

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