BASEL, Switzerland, June 5 /Xinhua-PRNewswire/ -- New
23-month follow-up data from HERA, one of the largest breast
cancer trials ever carried out, show that Herceptin
(trastuzumab) following standard chemotherapy significantly
reduced the risk of death by 34% for women with early-stage
HER2-positive breast cancer.[1] The data also show that
Herceptin continues to provide patients with a reduced risk
of their cancer coming back. HER2-positive breast cancer,
which affects approximately 20% - 30%[2] of women with
breast cancer, demands special and immediate attention
because the tumours are fast-growing and there is a higher
likelihood of relapse.

    The data from the international HERA (HERceptin
Adjuvant) study were presented today at the American Society
of Clinical Oncology (ASCO) annual meeting in Atlanta, the
biggest conference for oncologists worldwide. These
follow-up data showed that Herceptin taken for 12 months
increases the chance of long-term survival by preventing the
development of advanced (metastatic) disease. Similar
disease-free and overall survival benefits from Herceptin in
this setting have also been seen in two large US trials,[3]
but the HERA study allowed for the use of a wide range of
standard chemotherapy regimens before treatment with
Herceptin, making these results highly meaningful to many
parts of the world.

    Professor Ian Smith, Head of the Breast Unit at Royal
Marsden Hospital, London, UK, and investigator of the HERA
study, commented, "These significant survival results
for Herceptin in the early breast cancer are very important.
Last year's HERA results showed that Herceptin could reduce
the risk of recurrence; now we have confirmation for the
first time that this means a better chance of staying alive.
HER2-positive breast cancer is a more aggressive form of the
disease, and it is very important that women diagnosed with
early breast cancer have a HER2 test to see if they would
benefit from Herceptin."

    Roche filed for an indication of Herceptin in
early-stage HER2-positive breast cancer in February 2006
based on the interim analysis of the 12-month arm of the
HERA data. The European Commission granted approval for this
indication on May 22, 2006.

    About the HERA study

    The HERA study is a randomised, phase III trial, which
evaluated the use of Herceptin versus observation following
a wide range of primary chemotherapy (chemotherapy given
before or after surgery) and radiotherapy (if applicable)
for 12 or 24 months in women with early-stage HER2-positive
breast cancer. The 23-month follow-up data show that
patients who received Herceptin in the 12-month arm had
statistically significant reductions in the risk of death
(hazard ratio = 0.66), as well as the risk of cancer coming
back (hazard ratio = 0.64).

    The HERA study has an external Independent Data
Monitoring Committee (IDMC) that regularly reviews safety
data. No safety concerns were raised by the IDMC, and the
incidence of severe congestive heart failure was very low
(0.6% in the Herceptin arm vs. 0% in the observation arm).
Patients in this study continue to be followed for any side
effects.

    HERA, conducted by the Roche and the Breast
International Group (BIG),[4] is one of the largest adjuvant
studies ever carried out among breast cancer patients;
enrolment to the trial began in December 2001, and nearly
5,100 HER2-positive patients were enrolled at 480 sites in
39 countries across the world. The HERA study allowed for
the use of a wide range of chemotherapy regimens, and both
lymph node-positive and lymph node-negative patients were
eligible for entry into the trial.

    The analysis of the 23-month follow-up compared
Herceptin versus observation and did not include a
comparison of 12 months versus 24 months treatment duration.
The trial will continue to assess this comparison and data
will become available in due time as the study matures.

    About breast cancer and Herceptin

    Eight to nine percent of women will develop breast
cancer during their lifetime, making it one of the most
common types of cancer in women.[5] Each year more than one
million new cases of breast cancer are diagnosed worldwide,
with a death rate of nearly 400,000 people per year.

    In HER2-positive breast cancer, increased quantities of
the HER2 protein are present on the surface of the tumour
cells. This is known as `HER2 positivity.' High levels of
HER2 are present in a particularly aggressive form of the
disease which responds poorly to chemotherapy. Research
shows that HER2-positivity affects approximately 20-30% of
women with breast cancer.

    Herceptin is a humanised antibody, designed to target
and block the function of HER2, a protein produced by a
specific gene with cancer-causing potential. In addition to
its efficacy in the early-stage breast cancer setting,
Herceptin also has demonstrated improved survival in the
advanced (metastatic) setting, where its addition to
chemotherapy allows patients to live up to one-third longer
than chemotherapy alone.[6]

    Herceptin received approval in the European Union in
2000 for use in patients with metastatic (advanced) breast
cancer, whose tumours overexpress the HER2 protein. It is
indicated for use as first-line therapy in combination with
docetaxel in patients who have not received chemotherapy for
their metastatic disease, first-line therapy in combination
with paclitaxel where anthracyclines are unsuitable, and
third-line therapy as a single agent. As of May 2006,
Herceptin is also approved in the European Union as adjuvant
therapy following standard chemotherapy for early-stage
HER2-positive breast cancer.

    Herceptin is marketed in the United States by
Genentech, in Japan by Chugai and internationally by Roche.
Since 1998, Herceptin has been used to treat over 230,000
HER2-positive breast cancer 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

    - About Genentech:  http://www.gene.com

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

    - Roche Health Kiosk on cancer: 
http://www.health-kiosk.ch/start_krebs

    To access video clips, in broadcast standard, free of
charge, please go
to:  http://www.thenewsmarket.com .

    References

    [1] Smith I, E. et al. Trastuzumab following adjuvant
chemotherapy in         
        HER2-positive early breast cancer (HERA trial):
disease-free and 
        overall survival after 2 year median follow-up.
Scientific Special 
        Session, American Society of Clinical Oncology
(ASCO) Annual Meeting 
        2006.

    [2] Harries M, Smith I. The development and clinical
use of trastuzumab 
        (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

    [3] Romond, E., Perez, E. et al. Trastuzumab plus
Adjuvant Chemotherapy 
        for Operable HER2 Positive Breast Cancer. New
England Journal of 
        Medicine 353:16 2005.

    [4] Collaborative partners for the HERA study include:
Roche, BIG and its 
        affiliated collaborative groups, plus
non-affiliated collaborative 
        groups, and independent sites.

    [5] World Health Organization, 2000.

    [6] Extra JM, Cognetti F, Maraninchi D et al. Long-term
survival 
        demonstrated with trastuzumab plus docetaxel:
24-month data from a 
        randomised trial (M77001) in HER2-positive
metastatic breast cancer. 
        Abstract #555, American Society for Clinical
Oncology (ASCO) Annual 
        Meeting 2005.

    For more information, please contact:

     Roche Group Media Office: 
     +41-61-688-8888
     basel.mediaoffice@roche.com

     - Baschi Durr, 
     - Alexander Klauser
     - Daniel Piller (Head of Roche Group Media Office)
     - Katja Prowald (Head of R&D Communications)
     - Martina Rupp

SOURCE  Roche