Herceptin Improves Survival in Women With Advanced HER2-Positive Breast Cancer Requiring Additional Treatment

San Antonio, Texas (ots/PRNewswire) -

- Studies Show Breast Cancer Patients Benefit From Continued Use
of Herceptin After Progression of the Disease

Data presented at the 30th Annual San Antonio Breast Cancer
Symposium confirm that Herceptin is the standard of care for women
with HER2-positive breast cancer across all stages of the disease.
The first interim evidence from a randomized phase III trial suggests
that Herceptin continues to work in patients requiring an additional
line of treatment for their metastatic disease. In addition, a large
retrospective analysis showed that use of Herceptin in these women
leads to improved survival when given in subsequent lines of
treatment.

Unfortunately, for many women with advanced breast cancer their
disease continues to spread after their initial treatment and
patients are likely to receive several subsequent lines and types of
therapy. These studies are important as they address the question of
whether continuing Herceptin in additional lines of treatment
provides benefit in women with advanced disease.

The study presented by Prof. von Minckwitz and colleagues compared
the use of Herceptin plus Xeloda (a standard chemotherapy) with
Xeloda alone after previous Herceptin therapy. The results showed
that patients who continued to receive Herceptin with the addition of
Xeloda achieved a higher response rate (48.9%) than with Xeloda alone
(24.6%)(1). In addition, growth of their cancer was prevented for a
longer period of time.

"These interim results from our phase III study demonstrate that
to continue treatment with trastuzumab and change the chemotherapy
regimen after initial progression of the disease provides benefit to
women with HER-2 positive metastatic breast cancer", commented Prof.
von Minckwitz, Lead Investigator of the study from the German Breast
Group.

Professor Jackisch and colleagues showed that in routine clinical
practice many women with HER2-positive metastatic breast cancer
receive Herceptin in a variety of combinations when additional
courses of therapy are required. In their analysis, treatment
schedules and outcomes for over 900 women receiving Herceptin were
assessed retrospectively over six years. Results show that giving
Herceptin in combination with chemotherapy achieves high response
rates and prolongs survival in patients who had previously received
Herceptin alone or in combination with other therapies as their first
line treatment.(2)

"Herceptin is highly effective and well tolerated in the routine
clinical management of patients with locally advanced or metastatic
HER2-positive breast cancer. It is very reassuring for women that the
study data suggest significant benefits in subsequent lines of
treatment" said Prof. Jackisch, Department of Obstetrics and
Gynecology and Breast Center at Offenbach Clinic, Offenbach, Germany.

The emerging evidence from these new studies and previous data
confirm that Herceptin is the standard of care for women with
HER2-positive breast cancer, offering the best chance of a cure and
helping women live longer.

Notes to editors:

About the von Minckwitz study

This is a phase III trial looking at Herceptin treatment in
patients with HER2-positive metastatic breast cancer requiring
subsequent lines of treatment. Interim results were presented at
SABCS 2007, with final results expected in 2008.

Women with HER2-positive locally advanced or metastatic breast
cancer that had received prior Herceptin with or without chemotherapy
as first line treatment were randomly assigned to receive Herceptin
(6 mg/kg body weight every 3 weeks) with capecitabine (2500
mg/m(squared) on days 1-14, q 21), or capecitabine treatment alone.
The primary end point was time to progression. The interim analysis
includes 156 patients.

About the Jackisch study

This is a retrospective German observational trial evaluating
routine clinical usage of Herceptin in advanced breast cancer from
2001 to 2006.

A total of 910 patients were followed in 142 German centres. The
median duration of documented Herceptin therapy was 11.2 months.
Additional information on long-term outcomes, progression-free
survival and overall survival were collected in a subgroup of 485
patients, in which treatment documentation had been finalized before
July 2004. Patients were stratified into three cohorts depending on
treatment type:

- Herceptin single-agent therapy: 102 patients (11%)

- Herceptin combined with chemotherapy with or without endocrine
therapy: 715 patients (79%)

- Herceptin combined with endocrine therapy only: 93 patients
(10%).

The effect of Herceptin treatment in patients requiring subsequent
lines of therapy was analysed in 112 patients continuing Herceptin
versus 81 patients not receiving Herceptin.

About breast cancer

Breast cancer is the most common cancer among women worldwide.(3)
Each year more than one million new cases of breast cancer are
diagnosed worldwide, and nearly 400,000 people will die of the
disease annually.(4)

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 percent of women with breast cancer.

About Herceptin (trastuzumab)

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. It has demonstrated efficacy in treating
both early and advanced (metastatic) breast cancer. Given on its own
as monotherapy as well as in combination with or following standard
chemotherapy, Herceptin has been shown to improve response rates,
disease-free survival and overall survival while maintaining quality
of life in women with HER2-positive breast cancer.

Herceptin received approval for use in the European Union for
advanced (metastatic) HER2-positive breast cancer in 2000, and for
early HER2-positive breast cancer in 2006. In the advanced setting,
Herceptin is now approved for use as a first-line therapy in
combination with paclitaxel where anthracyclines are unsuitable, as
first-line therapy in combination with docetaxel, and as a single
agent in third-line therapy. It is also approved for use in
combination with an aromatase inhibitor for the treatment of
post-menopausal patients with HER2 and hormone receptor co-positive
metastatic breast cancer. In the early setting, Herceptin is approved
for use following standard (adjuvant) chemotherapy.

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 nearly 450,000 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 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 in-vitro
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 http://www.roche.com.

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(1) Von Minckwitz G, et al. Trastuzumab treatment beyond
progression in patients with HER2 positive metastatic breast cancer -
interim report. Phase III trial. Abstract 4056. SABCS Meeting 2007

(2) Jackisch J, et al. Routine clinical usage of Trastuzumab
(Herceptin) in advanced breast cancer in Germany from 2001 to 2006.
Abstract 4059. SABCS Meeting 2007

(3) World Health Organization,
http://www.who.int/cancer/detection/breastcancer/en/

(4) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality
and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0.
IARCPress, Lyon, 2004. 2004

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

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