Avastin(R) Significantly Prolongs Progression Free Survival in Advanced Kidney Cancer

Avastin(R) Significantly Prolongs Progression Free Survival in Advanced Kidney Cancer

June 04, 2007

- Patients Have a Chance to Live Almost Twice as Long
Without Their Disease Returning


    CHICAGO, June 4 /Xinhua-PRNewswire/ -- Adding Avastin
(bevacizumab) to interferon offers patients with advanced
renal cell cancer the chance to live twice as long without
their disease advancing ("progression free
survival") compared with interferon alone. This is
according to results from the pivotal phase III AVOREN
trial presented today for the first time at the 43rd annual
meeting of the American Society of Clinical Oncology (ASCO)
in Chicago. 

    The results of the AVOREN trial showed that by adding
Avastin to interferon, a current standard of care in
advanced renal cell cancer:

    -- Progression free survival was almost doubled from a
median of
       5.4 to 10.2 months
    -- Tumour response was significantly increased from
12.8% with
       interferon alone to 31.4% when Avastin was added to
the
       treatment regimen

    "These results are significant because there is a
real need for more effective treatments in advanced kidney
cancer, where chemotherapy and radiotherapy are not as
effective as in other cancers" said Professor Bernard
Escudier, Head of Immunotherapy and Innovative Therapy
Unit, Institut Gustave-Roussy, Paris, France and Principal
Investigator of the study. "Avastin has been shown to
be efficacious and well tolerated and is an important new
treatment option in the fight against this cancer."

    The study also showed a trend towards improved overall
survival; however, the overall survival data are still
pending. No new or unexpected adverse events were
observed.

    On an annual basis, in excess of 200,000 people
worldwide will receive a diagnosis of kidney cancer and
more than 100,000 people worldwide will lose their lives to
the disease.(i) These figures can be expected to increase as
the number of people suffering from cancer rises 50%, as
recently estimated by the WHO.(ii) Roche submitted a
Marketing Authorisation Application (MAA) to the European
Medicines Evaluation Agency (EMEA) based on the landmark
AVOREN study in April 2007.

    About AVOREN

    The AVOREN study is a randomised, controlled,
double-blind Phase III study that included 649 patients
from 101 study sites across 18 countries. In the study
patients received treatment with either Avastin and
interferon alpha-2a or placebo and interferon alpha-2a, a
standard of care in advanced kidney cancer.

    The primary endpoint of the study was to demonstrate
overall survival when Avastin was added to interferon
alpha-2a therapy. The study protocol specified an interim
overall survival analysis be performed at approximately 50
percent of events. Secondary endpoints included progression
free survival (PFS), time to progression, time to treatment
failure, overall response rate and safety profile. A final
progression-free survival analysis was specified in the
Statistical Analysis Plan to occur at the time of an
interim overall survival analysis and was presented at the
ASCO 2007 conference.

    The benefits of Avastin shown during the trial were so
positive that based on earlier interim results in December
2006, the Drug Safety Monitoring Board (DSMB) recommended
that the trial was unblinded and all patients were offered
treatment with Avastin. The study demonstrated, for the
first time that Avastin also benefits patients in
combination with an immunotherapeutic.

    In the US, in prior consultation with the FDA, the
primary analysis endpoint of the AVOREN study was revised
to assess improvement in PFS, defined as the length of time
the tumour did not grow or patient death did not occur.

    About Kidney Cancer

    Kidney cancer is more common in men than women
(approximately 62% of renal cell carcinoma occurs in males)
and incidence increases with age(i,ii).

    Renal cell carcinoma (RCC) is the most common type of
kidney cancer, accounting for nine out of ten cases. Within
this cancer type, there are several types of cancer based on
looking at the cells under a microscope. Clear cell renal
cell cancer is the most common type. If RCC is diagnosed at
an early stage when the cancer is still confined to the
kidney, the 5 year survival rates are relatively good at
60-75%. However, if diagnosis is made at a later stage and
the cancer has already spread to distant sites the 5 year
survival rate is less than 5%(iii). Unfortunately, because
kidney cancer is often asymptomatic, the majority of
patients are diagnosed at later disease stages.

    Treatment options for patients with kidney cancer are
limited. Surgical removal of part or the entire kidney
forms the mainstay of treatment but is only really
successful in early stage disease. In later stage disease,
treatment is more often employed with a view of controlling
the cancer and improving associated symptoms.

    About Avastin

    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).

    Avastin has now demonstrated a progression-free and/or
overall survival benefit for patients in four cancer types,
namely: colorectal, breast, lung and renal cell cancer.

    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 ie
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 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 diagnostics
and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas
such as autoimmune diseases, inflammation, metabolism and
central nervous system. In 2006 sales by the
Pharmaceuticals Division totaled 33.3 billion Swiss francs,
and the Diagnostics Division posted sales of 8.7 billion
Swiss francs. Roche employs roughly 75,000 worldwide 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 at
http://www.roche.com.

    All trademarks used or mentioned in this release are
protected by law.

    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 
    -- Avastin: http://www.avastin-info.com 

    References

    (i) Parkin DM, Bray F, Ferlay J and Pisani P. Global
cancer statistics 2002. CA Cancer J Clin 2005; 55; 74 -
108.

    (ii) WHO Information sheet on cancer
http://www.who.int/dietphysicalactivity/publications/facts/cancer/en/
(accessed 24th May 2007)

    (iii) Medline Plus
http://www.nlm.nih.gov/medlineplus/ency/article/000516.htm
(accessed on 23rd October 2006)


    For more information, please contact:

     Erica Bersin, Roche
     Tel:    [phone]
     Mobile: [phone]

     Jon Harris, Galliard Healthcare
     Tel:    [phone]