Avastin and Xeloda Meet Primary Endpoints in Large Phase III First Line Metastatic Colorectal Cancer Study

Avastin and Xeloda Meet Primary Endpoints in Large Phase III First Line Metastatic Colorectal Cancer Study

July 31, 2006

    BASEL, Switzerland, July 31 /Xinhua-PRNewswire/ --
Roche announced today that a large, international Phase III
study (NO16966) enrolling 2,035 previously untreated
metastatic colorectal patients met both primary endpoints.

    Results of the study showed that:

    -- The chemotherapy combination Xeloda plus
oxaliplatin, called XELOX is as effective in terms of
progression-free survival (PFS) -- a measure of the time
patients live without their disease progressing -- as
infused 5-FU/leucovorin plus oxaliplatin, called FOLFOX;

    -- The addition of Avastin to chemotherapy (FOLFOX and
XELOX) significantly improved progression-free survival
compared to chemotherapy alone.

    Some variability in treatment benefit was observed in
subgroups. No new safety signals related to Avastin were
observed in the trial.

    "This is the first time that we have significant
data showing that oral Xeloda in combination with
oxaliplatin is as effective as FOLFOX, demonstrating that
XELOX provides a new treatment option for colorectal cancer
patients," said Ed Holdener, Head of Global Development
at Roche. "These data again show the benefit of adding
Avastin to chemotherapy. In this trial Avastin combined
with FOLFOX and XELOX improved the chance of delaying
progression of the disease by 20% in patients with
metastatic colorectal cancer."

    Results from the study will be submitted to a future
international cancer congress.

    In 2004, colorectal cancer was one of the leading
cancers and accounted for 13 percent of all cancers.(1) 

    It is estimated that more than 394,000 people die
worldwide from colorectal cancer each year.(2)

    About the Study

    The NO16966 trial is a large, international phase III
trial which randomized 2,035 patients and compared as first
line colorectal cancer treatment initially:

    -- XELOX (Xeloda plus oxaliplatin) vs FOLFOX
(intravenous bolus and infusional 5-fluorouracil plus
oxaliplatin) After release of the pivotal Avastin data in
colorectal cancer in 2003, the protocol was amended to
investigate in a 2 by 2 factorial design:

    -- XELOX + placebo vs XELOX + Avastin (7.5 mg/kg q3w)vs
FOLFOX + placebo vs FOLFOX + Avastin (5.0 mg/kg q2w).

    The primary objectives were to answer two questions:
firstly whether the XELOX regimen is non-inferior to FOLFOX
and secondly whether the addition of Avastin to chemotherapy
is superior to chemotherapy alone. The secondary endpoints
included overall survival, overall response rates, and
safety profile.

    About XELOX

    An abbreviation for a type of combination chemotherapy
used to treat colorectal cancer; it contains Xeloda
(capecitabine) plus oxaliplatin.

    About Xeloda (capecitabine)

    Xeloda is licensed in more than 90 countries worldwide
including the EU, USA, Japan, Australia and Canada and has
been shown to be an effective, safe, simple and convenient
oral chemotherapy in treating over 1 million patients to
date.

    Roche received marketing authorisation for Xeloda as a
first-line monotherapy (by itself) in the treatment of
metastatic colorectal cancer (colorectal cancer that has
spread to other parts of the body) in most countries
(including the EU and USA) in 2001. Xeloda has also been
approved by the European Medicines Agency (EMEA) and U.S.
Food and Drug Administration (FDA) for adjuvant
(post-surgery) treatment of colon cancer in March and June
2005, respectively.

    Xeloda is licensed in combination with Taxotere
(docetaxel) in women with metastatic breast cancer (breast
cancer that has spread to other parts of the body) and
whose disease has progressed following intravenous (i.v.)
chemotherapy with anthracyclines. Xeloda monotherapy is
also indicated for treatment of patients with metastatic
breast cancer that is resistant to other chemotherapy drugs
such as paclitaxel and anthracyclines. Xeloda is licensed
for the first-line treatment of stomach cancer that has
spread, in South Korea.

    The most commonly reported adverse events with Xeloda
include diarrhoea, abdominal pain, nausea, stomatitis and
hand-foot syndrome (palmar-plantar erythrodysesthaesia).

    About Avastin (bevacizumab)

    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).

    In Europe, Avastin was approved in January 2005 and in
the US in February 2004 for the first-line treatment of
patients with metastatic colorectal cancer. It received
another approval in the US in June 2006 as a second-line
treatment for patients with metastatic colorectal cancer.
The first filing for Avastin in Japan occurred in April
2006 for the treatment of metastatic colorectal cancer.
More recently, Avastin was filed for the treatment of women
with metastatic breast cancer in the EU in July 2006, which
followed the US May 2006 filing.

    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 i.e.
post-operation). The total development programme is
expected to include over 40,000 patients worldwide.

    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
legally protected.

    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 

    References:

    1. Boyle P, Ferlay J. Cancer incidence and mortality in
Europe, 2004.
       Annals of Oncology 2005; 16:481-488

    2. Boyle P, Langman JS. ABC of colorectal cancer.
Epidemiology. BMJ 2000;
       321:805-808

    For more information, please contact:

    Roche Group Media Office

     Baschi Durr, Alexander Klauser or Martina Rupp, or
     Daniel Piller, Head Roche Group Media Office, or 
     Katja Prowald, Head Science Communications
     Tel:   [phone]
     Email: [e-mail] 
     Web:   http://www.roche.com   

SOURCE  Roche