Important Progress in Treatment of Early and Late Stage Breast Cancer With Herceptin, Avastin and T-DM1

Basel, Switzerland (ots/PRNewswire) -

- Roche to Present new Results That Could Offer a Better Future
to Women With Early and Very Advanced Breast Cancer, at the
CTRC-AACR San Antonio Breast Cancer Symposium

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new 5
year follow-up data from two pivotal studies with Herceptin(R)
(trastuzumab) in early breast cancer; key results from a study of
Avastin(R) (bevacizumab) in the second-line treatment of advanced
breast cancer and strong data on the use of trastuzumab-DM1 (T-DM1),
the first antibody-drug conjugate in development for very advanced
HER2-positive breast cancer, will all be presented during the
CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) from 9 to 13
December 2009.

"Breast cancer is the most common cancer among women worldwide
with more than one million new cases diagnosed every year and nearly
400,000 deaths, so it is vital that we continue to provide more
treatment options," said William M. Burns, CEO of Roche Pharma. "The
much anticipated data on Herceptin, Avastin and the investigational
drug T-DM1 will be welcomed by physicians treating women with early
and very advanced stages of breast cancer as it will offer them more
choices for fighting this devastating disease."

Two Herceptin studies in early breast cancer, five year follow up
data (N9831, BCIRG 006)

- 5-years of follow-up data will be presented from these pivotal phase
III studies that have already shown efficacy in patients when adding 12
months of Herceptin to standard therapy.
- Both studies were seeking to answer questions the medical community has
been contemplating regarding the best way of giving their patients
Herceptin treatment.
Avastin RIBBON-2 study, second-line treatment data
- Avastin is well established as a first-line treatment for women with
advanced breast cancer. RIBBON-2 will report on the benefits of Avastin
in combination with commonly used chemotherapies in the second-line
setting where currently the only option is subsequent chemotherapy.

T-DM1 4374 study in very advanced breast cancer

New data from a phase II study (TDM4374) in a very advanced
patient population who have exhausted other treatment options will be
presented. This follows on from another phase II study (TDM4258) that
was presented at ASCO 2009 which showed encouraging results in women
with advanced HER2-positive breast cancer.

In addition, further data from the phase II study BO17929 will be
presented, demonstrating that the combination of pertuzumab and
trastuzumab shows efficacy in patients with HER2-positive advanced
breast cancer whose disease had progressed during prior treatment
with Herceptin plus chemotherapy.[i] The data, which suggest that
combining pertuzumab and trastuzumab may offer an effective new
treatment option to patients with HER2-positive advanced breast
cancer, have been accepted as a poster presentation on Saturday 12
Dec, 17:30 - 19:30, Poster Session 5, Exhibit Halls A-B.

Details of key studies being presented:

Herceptin N9831 study

The study is part of the official SABCS press programme on
Saturday 12 Dec., 08:00 hrs.

Dr E. Perez, Results of chemotherapy alone, with Oral
et al sequential or concurrent addition of presentation
trastuzumab in the NCCTG N9831 Saturday 12
HER2-positive adjuvant breast cancer Dec, 15:00,
trial. General
Session 6,
Exhibit Hall
D.
Herceptin BCIRG 006 study
Dr. D. Slamon, Phase III randomized trial comparing Oral
et al doxorubicin and cyclophosphamide followed presentation
by docetaxel (AC à T) with doxorubicin and Saturday 12
cyclophosphamide followed by docetaxel and Dec, 09:45,
trastuzumab (AC à TH) with docetaxel, General
carboplatin and trastuzumab (TCH) in Session 5,
Her2neu positive early breast cancer Exhibit Hall
patients: BCIRG 006 study. D.
Avastin RIBBON-2 study
The study is part of the official SABCS press programme on Friday 11
Dec., 12:30 hrs.
Dr. A. RIBBON-2: A randomized, double-blind, Oral
Brufsky, et al placebo-controlled, phase III trial presentation
evaluating the efficacy and safety of Friday 11
bevacizumab in combination with Dec, 15:00,
chemotherapy for second-line treatment of General
HER2-negative metastatic breast cancer. Session 4,
Exhibit Hall
D.
T-DM1 4374 study
Dr. I. Krop, A phase II study of trastuzumab-DM1 Poster
et al (T-DM1), a novel HER2 antibody-drug presentation
conjugate, in patients previously treated Saturday 12
with lapatinib, trastuzumab, and Dec, 07:00 -
chemotherapy. 09:00.
Poster
Discussion
7, Ballroom
B.

The above mentioned studies and data represent the latest results
of clinical research for each treatment and are not necessarily part
of the indicated licence in each country. For detailed label
information, visit the website of your health authority or the EMEA
website http://www.emea.europa.eu/

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.[ii]

The 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS)
takes place from 9 to 13 December 2009. Full details can be found at
http://www.sabcs.org/.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world's largest biotech
company with truly differentiated medicines in oncology, virology,
inflammation, metabolism and CNS. Roche is also the world leader in
in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche's personalised healthcare strategy aims
at providing medicines and diagnostic tools that enable tangible
improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80'000 employees worldwide and invested
almost 9 billion Swiss francs in R&D.

The Group posted sales of 45.6 billion Swiss francs. Genentech,
United States, is a wholly owned member of the Roche Group. Roche has
a majority stake in Chugai Pharmaceutical, Japan. For more
information: http://www.roche.com.

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

Additional information

- Roche SABCS materials:
http://www.roche.com/media/events/med-sabcs2009.htm
- More about Roche's work in oncology:
http://www.roche.com/media_backgrounder/media_oncology.htm
- Oncology backgrounders:
http://www.roche.com/media_backgrounder/media_oncology.htm
- Roche.com section on PHC:
http://www.roche.com/research_and_development/phc_in_r_d.htm
- http://www.thenewsmarket.com
- Video clips and backgrounder on products:
http://www.roche.com/med-cor-2009-05-15.htm

References
---------------------------------

[i] Baselga J. et al., Abstract 1004. American Society of
Clinical Oncology Annual Meeting 2007.

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

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

Contact:
Roche Group Media Relations: Phone: +41-61-688-8888 / e-mail:
basel.mediaoffice@roche.com, Daniel Piller (Head), Alexander Klauser,
Martina Rupp, Claudia Schmitt, Nina Schwab-Hautzinger