- RIBBON-1 Study Confirms Benefit of Avastin in Treating HER2-Negative
- For Non-US, Non-UK and Non-Austrian Media
BASEL, Switzerland, May 29 /CNW/ - 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
- Secondary endpoints for the study included independently reviewed
PFS, response rate, overall survival, 1-year survival, safety and
RIBBON-1 comprised of two independently powered treatment groups
investigating either Avastin or placebo in combination with 7 distinct
- 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.
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
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.
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 www.who.int/mediacentre/factsheets/fs297/en/index.html
For further information:
For further information: Irina Berechet, Roche, +41-79-865-98-50;
Dominic Elliston, Galliard Healthcare, +44-7717-502-860