Avastin Plus Commonly Used Chemotherapies Improves the Time Breast Cancer Patients Live Without Their Disease Getting Worse

Basel, Switzerland (ots/PRNewswire) -

- RIBBON-1 Study Confirms Benefit of Avastin in Treating
HER2-Negative Breast Cancer

- For Non-US, Non-UK and Non-Austrian Media

Results from the phase III RIBBON-1 study presented today at ASCO
showed that patients with advanced HER2-negative breast cancer who
were treated with Avastin(R) (bevacizumab) plus the most commonly
used chemotherapies lived longer without their disease worsening
(progression free survival or PFS), compared to those being treated
with chemotherapies alone. RIBBON-1 confirms that Avastin can be
safely and effectively combined with a range of chemotherapies for
first line treatment of HER2-negative metastatic breast cancer,
offering patients and physicians more treatment options.

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This is the first study to show clinical benefit for patients
when combining Avastin with an anthracycline-containing regimen and
Xeloda(R) (capecitabine), and the third trial (following E2100 and
AVADO) to confirm the efficacy and safety of Avastin in combination
with standard chemotherapies for the treatment of advanced breast
cancer in the first line setting.

Key results from RIBBON-1 included:
- Up to 55% increase in the chance of the patient living without the
disease getting worse.
- A significant increase in tumour shrinkage in patients that received
Avastin (response rate = 51% vs. 37.9% for Avastin + anthracycline or
taxane chemotherapy vs. chemotherapy alone).
- There were no new safety signals for Avastin in RIBBON-1, confirming
the safety and tolerability profile seen in previous studies.

'These results are further proof that Avastin based therapy is
part of the armamentarium of treatment for patients with advanced
breast cancer' said Dr Nicholas Robert, M.D, Co-chair Breast Cancer
Research Committee, U.S. Oncology, Inc., investigator of the RIBBON-1
study. 'The growing body of evidence supporting the combination of
Avastin with commonly used chemotherapy regimens, gives physicians
more flexibility to tailor the most appropriate course of Avastin
based therapy for their patients.'

Despite the treatment improvements that have already been made,
breast cancer continues to be the leading cause of cancer death in
women under the age of 55 and more than one million women are
diagnosed each year, leading to more than 500,000 deaths from the
disease worldwide(1),(2).

About the RIBBON-1 study

RIBBON-1 is a global double blind, placebo-controlled, randomised
phase III trial including 1,237 patients who did not receive previous
chemotherapy for their HER2-negative locally recurrent or metastatic
breast cancer.

- The primary objective of RIBBON-1 was to demonstrate superiority in PFS
of Avastin containing treatment arms compared to the control arms.
- Secondary endpoints for the study included independently reviewed PFS,
response rate, overall survival, 1-year survival, safety and
tolerability.

RIBBON-1 comprised of two independently powered treatment groups
investigating either Avastin or placebo in combination with 7
distinct chemotherapy regimens:

- Taxanes - docetaxel or protein bound paclitaxel
- Anthracyclines - doxorubicin- or epirubicin-based regimen

Standard anthracyline-based regimens included the following:

- FEC (Fluorouracil (5FU), epirubicin and cyclophosphamide),
- EC (epirubicin and cyclophosphamide),
- AC (doxorubicin and cyclophosphamide),
- FAC (Fluorouracil (5FU), doxorubicin and cyclophosphamide)
- Xeloda (capecitabine)

Avastin yielded superior PFS in both treatment groups.

About Avastin

Avastin is an antibody that specifically binds and blocks VEGF
(vascular endothelial growth factor). VEGF is the key driver of
tumour angiogenesis - an essential process of development and
maintenance of blood vessels which is required for a tumour to grow
and to spread (metastasise) to other parts of the body. Avastin's
precise mode of action helps control tumour growth and metastases
with only a limited impact on side effects of chemotherapy.

Avastin has proven survival benefits across multiple tumour
types. Avastin is approved in Europe for the treatment of the
advanced stages of four common types of cancer: colorectal cancer,
breast cancer, lung cancer and kidney cancer. These types of cancer
collectively cause nearly 3 million deaths each year. In the US,
Avastin was the first anti-angiogenesis therapy approved by the FDA
and is now approved for the treatment of four tumour types: breast,
colorectal, glioblastoma, and non small cell lung cancer (NSCLC).

More than 500,000 patients have been treated with Avastin so far.
A comprehensive clinical programme with more than 450 clinical trials
is investigating the use of Avastin in various tumour types
(including colorectal, breast, lung, brain, gastric, ovarian,
prostate and others) and different settings (advanced or early stage
disease).

About Xeloda (capecitabine)

Xeloda, capecitabine, is a highly effective targeted oral
chemotherapy offering patients a survival advantage when taken on its
own or in combination with other anticancer drugs. Xeloda uniquely
activates the cancer-killing agent 5-FU (5-fluorouracil) directly
inside the cancer cells so avoiding damage to healthy cells. Xeloda
tablets can be taken by patients in their own home, reducing the
number of hospital visits.

Licensed and marketed by Roche in more than 100 countries
worldwide, Xeloda has more than ten years of proven clinical
experience providing an effective and flexible treatment option to
over 1.8 million people with cancer. Xeloda is currently approved in
metastatic colorectal cancer, metastatic breast cancer, adjuvant
colon cancer, advanced gastric cancer, metastatic pancreatic cancer.

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

References

1. Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA:
American Cancer Society, 2007.

2. WHO Cancer Factsheet No.297 - updated July 2008. Last accessed
24 March 2009 at
http://www.who.int/mediacentre/factsheets/fs297/en/index.html

For more information please contact:
Irina Berechet
Roche
+41-79-865-98-50
Dominic Elliston
Galliard Healthcare
+44-7717-502-860

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

Contact:
For more information please contact: Irina Berechet, Roche,
+41-79-865-98-50; Dominic Elliston, Galliard Healthcare,
+44-7717-502-860