Investor Update
Basel, 17 Dec 2007
Herceptin
improves
survival in women with advanced HER2-positive breast cancer requiring additional treatment
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.
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/m² 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 www.roche.com.
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References
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