MEDIA RELEASE PR37494
Important Progress in Treatment of Early and Late Stage Breast Cancer With Herceptin, Avastin and T-
DM1
BASEL, Dec. 9 /PRNewswire-AsiaNet/ --
- 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
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
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:
All trademarks used or mentioned in this release are protected by law.
Additional information
- Roche SABCS materials:
- More about Roche's work in oncology:
- Oncology backgrounders:
- Roche.com section on PHC:
- Video clips and backgrounder on products:
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.
SOURCE: Roche
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