New phase III study of Avastin in advanced breast cancer meets its primary endpoint of increasing the time patients live without their disease getting worse

Third study confirming the benefit of Avastin in breast cancer shows that Avastin can be effectively combined with commonly used chemotherapies

Roche announced today that the Avastin study RIBBON-1 met its primary endpoint of increasing the time women with breast cancer lived without their disease advancing (known as progression-free survival) compared to chemotherapy alone, as determined by the treating physicians. RIBBON-1 is a double blind  phase III study in first-line metastatic HER-2 negative breast cancer investigating Avastin (bevacizumab) in combination with either taxane-based, anthracycline-based or Xeloda (capecitabine) chemotherapies. The data will be submitted for presentation at a future medical meeting.

"This is really important news for breast cancer patients and physicians" said William M. Burns, CEO Division Roche Pharmaceuticals. "This study proves that patients benefit when Avastin is combined with commonly used chemotherapy which will give physicians more flexibility when selecting the most appropriate course of Avastin-based therapy for their patients."

RIBBON-1 is the first phase III study to show Avastin's benefit when combined with Xeloda as well as anthracycline-based chemotherapies in this patient population and it also substantiates the benefits of Avastin when combined with taxane-based chemotherapies. The results are further proof that Avastin can be effectively combined with several commonly used chemotherapies for first-line treatment of  HER- 2 negative metastatic breast cancer, allowing patients to live longer without their disease getting worse.  

RIBBON-1 supports the previously established safety profile of Avastin.

About the RIBBON-1 study

RIBBON-1 is a globally conducted randomised  phase III trial with  1,237 patients who did not receive previous chemotherapy for their metastatic breast cancer. RIBBON-1 comprised of two independently powered treatment groups investigating either Avastin or placebo in combination with:

• Taxane or anthracycline chemotherapies or
• Xeloda

Avastin yielded superior progression-free survival in both treatment groups.

The primary objective of RIBBON-1 was to demonstrate superiority in progression-free survival of Avastin containing treatment arms compared to the control arms. Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, quality of life, safety and tolerability.

In RIBBON-1, 7 distinct chemotherapy regimens were evaluated (taxanes (docetaxel or protein bound paclitaxel), anthracyclines (doxorubicin- or epirubicin-based regimen), or Xeloda), with or without Avastin. 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)

About Avastin (bevacizumab)

In breast cancer:

• • Safety and efficacy of Avastin in combination with taxanes for the treatment of metastatic or advanced breast cancer have been confirmed based on data from two large pivotal phase III studies, both of which met their primary endpoint:

  -Pivotal data from the E2100 study, which formed the basis of Avastin's European approval in metastatic breast cancer in March 2007, showed that women with metastatic breast cancer have the chance to live twice as long without their cancer advancing ("progression-free survival") if treated with Avastin plus paclitaxel compared to paclitaxel alone.
  -Data from the AVADO study showed that Avastin significantly increases progression-free survival and response rate (shrinkage of the tumour) when combined with docetaxel compared to docetaxel alone.

In cancer overall:

• To date, Avastin has been used to treat more than  350,000 cancer patients. Furthermore, Avastin's anti-cancer benefits are currently being assessed in a further 20 cancer types in various stages of disease through a global clinical trial programme including more than 40,000 patients around the globe.
• Avastin is approved for use 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 (NSCLC)
• March 2007 (EU) - first-line treatment in patients with metastatic breast cancer
• April 2007 (Japan) - treatment in patients with recurrent or advanced CRC
• December 2007 (EU) - first-line treatment in patients with advanced RCC
• January 2008 (EU) - first and later-line treatment in patients with mCRC in combination with any chemotherapy
• February 2008 (US) - first-line treatment in patients with HER-2 negative metastatic BC

About Xeloda (capecitabine)

Licensed in more than 100 countries worldwide, Xeloda has over ten years proven clinical experience providing an effective and flexible treatment option to over 1.5 million people with cancer. Xeloda is currently approved in:

• • Metastatic Colorectal Cancer

  -Monotherapy first-line (US & EU) - 2001
  -In combination with any chemotherapy in all lines of treatment with or without Avastin (EU) - 2008

• Metastatic Breast Cancer
  -Monotherapy first-line in patients with tumours resistant to other chemotherapy drugs such as paclitaxel and anthracyclines - (US) 1998 and (EU) 2002
  -In combination with docetaxel in patients whose disease has progressed following iv chemotherapy with anthracyclines - (US) 2001 and (EU) 2002
  -In patients with inoperable or recurrent breast cancer - (Japan) 2003
• Adjuvant Colon Cancer
  -Monotherapy (US & EU) - 2005
  -Monotherapy (Japan) - 2007
• Advanced Gastric Cancer
  -First-line treatment (South Korea) - 2002
  -In combination with platinum-based chemotherapy first-line (EU) - 2007
• • Metastatic Pancreatic Cancer

  -In combination with gemcitabine first-line (South Korea) - 2006

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 the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.