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



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

    CHICAGO, June 2 /CNW/ - 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, 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 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 totalled 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 www.roche.com.

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

    Additional information

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

    - Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs

    - Avastin: 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 www.nlm.nih.gov/medlineplus/ency/article/000516.htm
(accessed on 23rd October 2006





For further information:

For further information: Roche: Erica Bersin, +41-61-688-2164 (direct),
+41-79-618-7672 (mobile on-site at ASCO); Galliard Healthcare: Jon Harris,
+44-0207-663-2261 (direct)

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