Xeloda Filed in Europe for Treatment of Advanced Stomach Cancer

Xeloda Filed in Europe for Treatment of Advanced Stomach Cancer

July 21, 2006

Oral Cancer Drug Offers Patients With Stomach Cancer a Highly Effective and Safe Treatment Option Compared to Current Standard Therapy
-- Not for publication in the US --

    BASEL, Switzerland, July 21 /Xinhua-PRNewswire/ -- The
European Medicines Agency informed Roche today that the
filing for a new indication in Europe for the oral cancer
drug Xeloda in combination with another chemotherapy
(cisplatin) for the treatment of patients with advanced
gastric (stomach) cancer has been accepted. Stomach cancer
is the fourth most commonly diagnosed cancer and the second
leading cause of cancer-related deaths worldwide.(1)

    The filing is based on results from the first-ever
phase III study investigating the efficacy and safety of
Xeloda/cisplatin compared to the current standard therapy
of infusional 5-fluorouracil (5-FU) plus cisplatin as
first-line treatment of the disease. The study results
confirmed that patients receiving the Xeloda/cisplatin
combination therapy lived at least as long without the
cancer progressing as those treated with the current
standard therapy. Furthermore, for the first time in any
cancer, Xeloda/cisplatin response rate (percentage of
patients whose cancer shrinks after treatment) was
superior, when compared to infusional 5-FU. Xeloda greatly
simplifies the treatment regimen due to its oral form,
reducing the need for hospital visits and allowing patients
more precious time to spend with family and friends. 

    "Today marks a significant milestone for Roche. We
are setting in motion the necessary steps to make this new
and effective treatment available for European patients
fighting advanced stomach cancer -- a particularly painful
and debilitating form of cancer," said Ed Holdener,
Head of Roche Pharmaceuticals Development.

    "These new robust data are very encouraging -- for
the first time a viable alternative to the current standard
intravenous treatment will become available for stomach
cancer patients in Europe," stated lead investigator
Prof. Y. K. Kang of the Asan Medical Center, Seoul, South
Korea. 

    In Europe alone, nearly 140,000 people die from stomach
cancer each year.(2) Stomach cancer affects twice as many
men as women and occurs more frequently in people aged over
55 years.(3) Amongst tumours of the upper gastrointestinal
tract, oesophagogastric cancer is more common in the West,
whilst stomach cancer is predominant in the East.(4)

    About the ML17032 study

    The study, conducted by Prof. Kang and his team, is a
large international phase III study in advanced stomach
cancer. Some key highlights from this remarkable study,
'Randomised phase III trial of capecitabine/cisplatin vs.
continuous infusion of 5-FU/cisplatin as first-line therapy
in patients with advanced gastric cancer: efficacy and
safety results' include:

    - This phase III study was conducted in 316 advanced
gastric cancer 
      patients who were enrolled in 46 centres across 13
countries in Asia, 
      South America, and Eastern Europe.

    - The study compared the efficacy and safety of the
Xeloda plus cisplatin 
      combination (XP) with the intravenous 5-FU plus
cisplatin combination 
      (FP); FP is a standard treatment for gastric cancer,
and accepted by 
      regulatory agencies as the reference regimen against
which all other 
      regimens should be compared.

    - The primary endpoint was non-inferiority in
progression-free survival; 
      patients receiving the XP combination therapy lived
at least as long 
      without the cancer progressing as those treated with
FP (median 
      progression-free survival 5.6 vs. 5 months, HR= 0.81,
p=<0.001, 
      demonstrating non-inferiority). 

    - The level of toxicity was similar between the two
treatment arms. 
      Gastrointestinal adverse events were among the most
frequent adverse 
      events in both treatment groups with nausea and
vomiting being the most 
      predominant adverse events.

    - XP patients also lived at least as long overall (10.5
vs. 9.3 months, 
      HR=0.85, p=0.008, demonstrating non-inferiority).

    - XP response rate based on investigator assessment was
superior to 
      FP -- this is the first time that Xeloda has shown
superiority to 
      infusional 5-FU rather than bolus 5-FU (overall
response rate 
      41 vs. 29 percent, p=0.030).

    - XP reduces the amount of time a patient needs to
visit the clinic by 
      80 percent compared to FP (1 day vs. 5 days per 3
weeks).

    About Xeloda

    Xeloda is licensed in more than 90 countries worldwide
including the EU, USA, Japan, Australia and Canada and has
been shown to be 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.

    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
protected by law.

    Additional information:

    - Gastric and oesophageal cancer fact sheet 

    - Xeloda fact sheet

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

    - Broadcast quality B-roll including doctor, caregiver
and patient 
      interviews is available for download via
http://www.thenewsmarket.com

    References:

    1. Ajani, J. Evolving Chemotherapy for Advanced Gastric
Cancer. The 
       Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-582.

    2. Boyle, P & Ferlay, J. Cancer incidence and
mortality in Europe. 2004.
       Annals of Oncology 2005; 16(3):481-4883.

    3. Oncology Channel.
http://www.oncologychannel.com/gastriccancer/ . Visited on

       15th March 2006.

    4. Crew, K & Neugut, A. Epidemiology of gastric
cancer. World J 
       Gastroenterol. 2006 Jan 21; 12(3):354-62

    For more information, please contact:

     Baschi Durr or Alexander Klauser or Martina Rupp, or 
     Daniel Piller, Head Roche Group Media Office, or 
     Katja Prowald, Head R&D Communications           
     Tel:   [phone]
     Email: [e-mail] 

SOURCE  Roche