Pertuzumab With Herceptin(R) Shows Impressive Results in Women With Advanced HER2-Positive Breast Cancer

Basel, Switzerland (ots/PRNewswire) - New data from a Phase
II trial presented at the American Society of Clinical Oncology
(ASCO) 2008 meeting showed that half of the patients with advanced,
HER2-positive metastatic breast cancer whose disease had progressed
during a Herceptin-containing regimen benefited from a combination of
Herceptin and pertuzumab.(1) Pertuzumab inhibits the pairing of HER2
with other HER receptors, a key mechanism of tumour growth. A
combination of Herceptin with pertuzumab may lead to a more powerful
blockade of the signalling pathways of HER2-positive breast cancer.

"This efficacy is the best I have observed with HER2-targeted
therapy without chemotherapy, and represents significant promise for
women with breast cancer in the future," said Dr Jose Baselga (Vall
d'Hebron University Hospital, Barcelona, Spain), lead investigator of
the Phase II trial.

"Its potential lies in its ability to target and block the most
relevant pathways for tumour growth. We are hopeful the combination
of Herceptin and pertuzumab used with chemotherapy will be even more
effective if used to treat women newly diagnosed with advanced
cancer. This combination is being investigated in the Phase III
CLEOPATRA study, which is currently recruiting patients."

In the Phase II study, nearly one in four patients saw their
tumours disappear (complete tumour response, 8 %) or shrink (partial
tumour response, 16 %). A further 25% of patients saw their cancer,
which had been progressing, stabilise for at least 6 months. The
combination of pertuzumab and Herceptin was well tolerated in this
group of patients and no patients were withdrawn from the trial with
treatment-related adverse events.

These results are important as, unfortunately, metastatic breast
cancer cannot be cured and so patients need improved and new
treatment options. The need for improved treatment options is
particularly important for women suffering from advanced aggressive
HER2-positive breast cancer.

The combination of Herceptin plus pertuzumab combined with
chemotherapy is being evaluated in first-line metastatic breast
cancer patients in another study, CLEOPATRA (CLinical Evaluation Of
Pertuzumab and TRAstuzumab). This Phase III study began recruiting
patients in January 2008 and is underway in 19 countries worldwide.
If this study is successful, this combination of Herceptin plus
pertuzumab and chemotherapy has the potential to become a new
standard of care in HER2-positive metastatic breast cancer.

Notes to Editors:

About breast cancer

Breast cancer is the most common cancer among women worldwide.(2)
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. 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.

About pertuzumab

Pertuzumab is the first in a class of innovative targeted agents
known as HER2-dimerisation inhibitors (HDIs).Pertuzumab is a
humanised monoclonal antibody designed to bind to the HER2 receptor
and inhibit the 'pairing' or dimerisation of HER2 with other HER
family receptors (HER1, HER2, HER3 and HER4). This pairing is
believed to play an important role in the growth and formation of
several different cancer types. Genentech and Roche are evaluating
pertuzumab in solid tumours (breast and ovarian cancers) and in
combination with other therapies. Pertuzumab is currently being
investigated in the Phase III CLEOPATRA (CLinical Evaluation Of
Pertuzumab And TRAstuzumab) study in patients with previously
untreated HER2-positive metastatic breast cancer, as well as in other
clinical studies.

About the Phase II study

This was a Phase II, open-label, single-arm trial of pertuzumab
and Herceptin in HER2-positive metastatic breast cancer. Patients
were eligible if their disease had progressed on Herceptin-based
therapy as their most recent treatment, and they may have received up
to three lines of previous therapy including Herceptin and
chemotherapy given as adjuvant treatment for breast cancer. Patients
had to have good cardiac function and no evidence of declining
cardiac function when given Herceptin previously.

Within 9 weeks of their last dose of Herceptin, patients
received:

- Herceptin, 2 mg/kg IV every week or 6 mg/kg IV every 3 weeks
- Pertuzumab, 840 mg IV day 1, then 420 mg every 3 weeks.

The study took place in two stages according to a modified Simon
design, with the primary endpoints of:

- objective response rate
- clinical benefit rate

and secondary endpoints of:

- time to response
- duration of response
- time to progression
- progression-free survival

Results from the first stage were presented at ASCO last year.(3)

No patients withdrew from the trial with treatment-related or
cardiac adverse events and the treatment was well-tolerated.

About CLEOPATRA

CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is
a Phase III randomised, double-blind, placebo-controlled clinical
trial evaluating the efficacy and safety of pertuzumab, Herceptin and
chemotherapy versus Herceptin and chemotherapy in previously
untreated HER2-positive metastatic breast cancer.

CLEOPATRA is currently recruiting in 19 countries (Argentina,
Brazil, China, Costa Rica, Finland, France, Germany, Hong Kong,
Italy, Korea, Mexico, Philippines, Poland, Russia, Singapore, Spain,
Thailand, UK and the US).

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 more than 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. Additional information is available on the
Internet at http://www.roche.com.

References

---------------------------------

(1) Gelmon K, Fumoleau P, Verma S, Wardley A, Conte PF, Miles D,
Gianni L, McNally VA, Ross GA and Baselga J. Results of a Phase II
trial of trastuzumab (H) and pertuzumab (P) in patients (pts) with
HER2-positive metastatic breast cancer (MBC) who had progressed
during trastuzumab therapy. J Clin Oncol 26: 2008 (May 20 suppl;
abstr 1026)

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

(3) Objective response rate in a Phase II multicenter trial of
pertuzumab (P), a HER2 dimerization inhibiting monoclonal antibody,
in combination with Trastuzumab (T) in patients (Pts) with HER2
positive metastatic breast cancer (MBC) which has progressed during
treatment with trastuzumab -- J. Baselga. ASCO 2007 oral
presentation.

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

Contact:
For further information: Corinne Fruendt, F. Hoffmann-La Roche Ltd.
Tel: +41(0)616-870-236, Mob: +41(0)795-937-216,
corinne.fruendt@roche.com; Peter Flynn, Axon Communications, Tel:
+44(0)20-8439-9477, Mob: +44(0)780-939-0667, pflynn@axon-com.com