Herceptin Eradicates Tumours and may Reduce the Need for Mastectomies in Women With Inflammatory HER2-Positive Breast Cancer - one of the Most Aggressive and Fastest Growing Forms of the Disease

Barcelona, Spain (ots/PRNewswire) -

- Abstract no: 2030, Being Presented at ECCO in the "Proffered
Papers: Breast Cancer - Early Disease" Session in the Forum,
Starting at 09.00am on Wednesday 26th September 2007

- For non-US Media Only

New data show that the addition of Herceptin(R) (trastuzumab) to
chemotherapy prior to breast cancer surgery (neoadjuvant therapy)
completely eradicates tumours in nearly three times as many women
with inflammatory HER2-positive breast cancer compared to
chemotherapy alone. Inflammatory breast cancer is a rare, but highly
aggressive form of the disease - the tumours spread quickly, often
leading to the need for full mastectomies, and it has a worse outlook
than other breast cancers. These results, presented at the European
Cancer Conference (ECCO 14) in Barcelona, are particularly
significant as treatment with Herceptin in this setting may actually
lead to more breast conserving surgery and most importantly to
potentially improved survival.

"This Herceptin data is very important for women with inflammatory
HER2-positive breast cancer, an extremely aggressive cancer," said
Prof. Dr. med. Wolfgang Eiermann, Medical Director, Red-Cross-Clinik
Munich. "Women could have their tumours eradicated by treating with
Herceptin and chemotherapy prior to surgery which could lead to fewer
mastectomies, and more importantly, fewer deaths from this type of
breast cancer".

HER2-positive disease is diagnosed in up to 30% of all breast
cancer cases.(1) It demands special attention because the tumours are
typically fast-growing and there is a high likelihood of relapse.
Neoadjuvant therapy is administered to patients to help make
inoperable tumours shrink and become removable, thus promoting breast
conserving surgery.

The results from the NeOAdjuvant Herceptin (NOAH) study
demonstrated that Herceptin plus chemotherapy led to the complete
disappearance of the tumour in the breast (a pathological complete
response to treatment) in nearly three times as many patients with
inflammatory breast cancer (55% vs. 19%, p=0.004) compared to
chemotherapy alone.(2) Furthermore, the combination led to complete
disappearance of the tumours from both the breast and the lymph nodes
(a total pathological complete response to treatment) in 48% of
patients, compared to only 13% of those who received chemotherapy
alone (p=0.002). The treatment was well tolerated with acceptable
cardiac safety. The trial is ongoing and event-free survival data are
maturing.

Notes to editors:

About the NOAH study

NOAH is a phase III trial assessing neoadjuvant Herceptin in
combination with chemotherapy in patients with HER2-positive locally
advanced breast cancer (LABC). Patients were assigned to one of two
cohorts depending on HER2 status. All patients received neoadjuvant
chemotherapy before surgery consisting of three cycles of
doxorubicin-paclitaxel (AT), four cycles of paclitaxel (T) and three
cycles of cyclophosphamide / methotrexate / 5-fluorouracil (CMF).
Patients with HER2-positive disease were randomised to receive
concomitant Herceptin for one year or chemotherapy only.

Out of 228 evaluable patients with HER2-positive breast cancer
that were included in the study, 61 had inflammatory breast cancer
(IBC). Of the 99 evaluable patients with HER2-negative breast cancer,
14 had IBC. 31 patients with HER2-positive IBC received Herceptin in
addition to chemotherapy. The analysis discussed in this news release
involves this subset of patients with inflammatory breast cancer.

The NOAH protocol is a joint effort of Fondazione Michelangelo,
Grupo SOLTI and Roche.

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 400,000 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 www.roche.com.

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

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

(2) Baselga J, et al., Efficacy of Neoadjuvant Trastuzumab in
Patients With Inflammatory Breast Cancer: Data From the NOAH
(NEOADJUVANT HERCEPTIN) Phase III Trial. Abstract #2030. ECCO 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

Contact:
For further information please contact: Nils Eckardt, F. Hoffmann-La
Roche Ltd, Mobile: +41-(0)-79-593-4357, nils.eckardt@roche.com;
Amanda Sefton, Ketchum, Mobile : +44-(0)-7707-812-968,
amanda.sefton@ketchum.com


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