BN003644 31 de maio de 2008 19:19 HORALOCAL
- New Data Provides the Basis for the Future Role of Erbitux
(cetuximab) as a Standard in Combination With Platinum-Based
Chemotherapy in the 1st-Line Treatment of Patients With Non-Small
Cell Lung Cancer (NSCLC)
- Location: Annual Meeting of the American Society of Clinical
Oncology (ASCO) 2008, Chicago, USA
CHICAGO and DARMSTADT, Germany, May 31 /PRNewswire/ -- The addition
of Erbitux(R) to a platinum-based chemotherapy significantly increased
overall survival in the 1st-line treatment of NSCLC.(1) This data was
presented today at the plenary session of the 44th American Society
of Clinical Oncology (ASCO) congress. The new findings confirm that
Erbitux is the first targeted therapy to show a significant survival
benefit in NSCLC patients across all histological subtypes.
"Lung cancer is notoriously difficult to treat and these results are
particularly exciting as they represent one of the most significant
advancements in the treatment of NSCLC in 10 years," commented
Professor Robert Pirker, lead investigator and Professor of Clinical
Oncology at the University of Vienna, Austria. "This opens new
1st-line treatment options for NSCLC patients, regardless of
histological type of cancer and sets a new standard in the treatment
of 1st-line NSCLC."
In the pivotal multinational, Phase III FLEX(a) trial, more than
1,100 patients with stage IIIB/IV NSCLC were randomized to receive
Erbitux plus standard platinum-based chemotherapy or chemotherapy
alone. The results demonstrated that in the 1st-line setting,
patients treated with Erbitux experienced significant benefits in
overall survival. Median overall survival was prolonged by 1.2 months
in the combination arm compared to those receiving chemotherapy alone
(11.3 vs 10.1 months).(1)
Patients from the major treatment group (Caucasians, representing 84%
of the trial population) experienced a significant increase in
overall survival of 1.4 months compared to those receiving
chemotherapy alone, reflected also in a hazard ratio of 0.8 (p=0.003).
In this group, patients with adenocarcinoma receiving Erbitux had a
survival benefit of 1.8 months compared to those in the control
arm.(1)
The FLEX trial included patients with all histological subtypes,
including adenocarcinoma and squamous cell carcinoma, as well as ECOG
2 patients who have much worse prognosis than patients with a better
performance status. "Since 94% of patients in the Erbitux plus
chemotherapy arm had stage IV metastatic NSCLC and 17% had
performance status 2, these data are not only robust, but also very
meaningful for the everyday clinical reality in the treatment of
1st-line NSCLC," commented Dr. Wolfgang Wein, Executive Vice
President, Oncology, at Merck KGaA, Darmstadt, Germany. "This is a
further verification of the outstanding quality of Erbitux
specifically and the oncology program at Merck KGaA in general."
Erbitux was found to be well tolerated in the trial with manageable
and expected side effects across the populations.(1)
The current standard treatment for 1st-line NSCLC includes a variety
of platinum-based chemotherapy doublets.(2) To date, Erbitux is the
first targeted therapy to show a significant survival benefit in a
broad population of patients -- including all histological subtypes
-- in the 1st-line treatment of NSCLC when added to standard
chemotherapy. The FLEX data support the outcomes of earlier studies
investigating Erbitux in combination with standard chemotherapies in
the 1st-line treatment of NSCLC, in which the addition of Erbitux
increased response rate and overall survival.(3),(4)
Worldwide, lung cancer is the leading cause of cancer death in men
and the second leading cause of cancer death in women.(5)
Approximately 975,000 men and 376,000 women die from the disease each
year.(6) NSCLC accounts for around 80% of lung cancers. Most patients
with NSCLC present with advanced disease which is difficult to
treat.(7) The overall five-year survival rate for lung cancer is
about 16%, compared to 65% for colon cancer, 89% for breast cancer and
99% for prostate cancer.(8)
(a). FLEX: First-line in Lung cancer with ErbituX
References
(1). Pirker R, et al. ASCO 2008;Abstract No: 3.
(2). Pfister D, et al. J Clin Oncol 2004;22:330-353.
(3). Butts C, et al. J Clin Oncol 2007;25:5777-5784.
(4). Rosell R, et al. Ann Onc 2008;19:362-369.
(5). Kamangar F, et al. J Clin Oncol 2006;24:2137-2150.
(6). Global Cancer Facts & Figures 2007, American Cancer Society.
(7). Corner J, et al. Thorax 2005;60(4)314-319.
(8). Lung Cancer Information (www.medicinenet.com, accessed May
2008).
About ERBITUX
ERBITUX(R) is a first-in-class and highly active IgG1 monoclonal
antibody targeting the epidermal growth factor receptor (EGFR). As a
monoclonal antibody, the mode of action of Erbitux is distinct from
standard non-selective chemotherapy treatments in that it
specifically targets and binds to the EGFR. This binding inhibits the
activation of the receptor and the subsequent signal-transduction
pathway, which results in reducing both the invasion of normal
tissues by tumor cells and the spread of tumors to new sites. It is
also believed to inhibit the ability of tumor cells to repair the
damage caused by chemotherapy and radiotherapy and to inhibit the
formation of new blood vessels inside tumors, which appears to lead
to an overall suppression of tumor growth.
The most commonly reported side effect with Erbitux is an acne-like
skin rash that seems to be correlated with a good response to
therapy. In approximately 5% of patients, hypersensitivity reactions
may occur during treatment with Erbitux; about half of these
reactions are severe.
Erbitux has already obtained market authorization in 72 countries. It
has been approved for the treatment of colorectal cancer in 71
countries so far: Argentina, Australia, Belarus, Canada, Chile,
China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El
Salvador, the European Union, Guatemala, Honduras, Hong Kong,
Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Liechtenstein,
Malaysia, Mexico, New Zealand, Nicaragua, Norway, Oman, Panama, Peru,
the Philippines, Qatar, Russia, Serbia, Singapore, South Africa,
South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, the US,
and Venezuela for use in combination with irinotecan in patients with
EGFR-expressing mCRC who have failed prior irinotecan therapy.
Erbitux is also approved for single-agent use in: Argentina,
Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic,
Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Lebanon,
Mexico, New Zealand, Nicaragua, Panama, Peru, the Philippines, Russia,
Singapore, Thailand, the US, and Venezuela.
In addition, Erbitux in combination with radiotherapy has been
approved for the treatment of locally advanced squamous cell
carcinoma of the head and neck (SCCHN) in 65 countries: Argentina,
Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El
Salvador, the European Union, Guatemala, Hong Kong, Iceland, India,
Indonesia, Israel, Kazakhstan, Lebanon, Liechtenstein, Malaysia,
Mexico, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the
Philippines, Qatar, Russia, Serbia, Singapore, South Africa,
Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In
Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong,
Israel, Lebanon, Mexico, Nicaragua, Peru, the Philippines, Russia,
and the US, Erbitux is also approved as monotherapy in patients with
recurrent and/or metastatic SCCHN who failed prior chemotherapy.
Merck licensed the right to market Erbitux outside the US and Canada
from ImClone Systems Incorporated of New York in 1998. In Japan,
ImClone Systems Incorporated, Bristol-Myers Squibb Company and Merck
jointly develop and, upon approval, commercialize Erbitux. Merck has
an ongoing commitment to the advancement of oncology treatment and is
currently investigating novel therapies in highly targeted areas,
such as the use of Erbitux in colorectal cancer, squamous cell
carcinoma of the head and neck and non-small cell lung cancer. Merck
has also acquired the rights for the cancer treatment UFT(R)
(tegafur-uracil) - an oral chemotherapy administered with folinic
acid (FA) for the 1st-line treatment of metastatic colorectal cancer.
Merck is also investigating among other cancer treatments the use of
Stimuvax(R) (formerly referred to as BLP25 Liposome Vaccine) in the
treatment of non-small cell lung cancer. The vaccine was granted
fast-track status in September 2004 by the FDA. Merck obtained the
exclusive worldwide licensing rights from Oncothyreon Inc., Bellevue,
Washington, USA.
About Merck Serono
Merck Serono is the division for innovative prescription
pharmaceuticals of Merck, a global pharmaceutical and chemical group.
Headquartered in Geneva, Switzerland, Merck Serono discovers,
develops, manufactures and markets innovative small molecules and
biopharmaceuticals to help patients with unmet medical needs. Its
North American business operates in the United States and Canada as
EMD Serono.
Merck Serono has leading brands serving patients with cancer
(Erbitux(R)), multiple sclerosis (Rebif(R)), infertility
(Gonal-f(R)), endocrine and cardiometabolic disorders (Glucophage(R),
Concor(R), Saizen(R), Serostim(R)), as well as psoriasis
(Raptiva(R)).
With an annual R&D investment of around EUR 1bn, Merck
Serono is committed to growing its business in specialist-focused
therapeutic areas including neurodegenerative diseases, oncology,
fertility and endocrinology, as well as new areas potentially arising
out of research and development in autoimmune and inflammatory
diseases.
For more information, please visit http://www.merckserono.net or
http://www.merck.de
About Merck
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Merck is a global pharmaceutical and chemical company with total
revenues of EUR 7.1 billion in 2007, a history that began in 1668,
and a future shaped by 31,681 employees in 60 countries. Its success
is characterized by innovations from entrepreneurial employees.
Merck's operating activities come under the umbrella of Merck KGaA, in
which the Merck family holds an approximately 70% interest and free
shareholders own the remaining approximately 30%. In 1917 the U.S.
subsidiary Merck & Co. was expropriated and has been an independent
company ever since.
SOURCE Merck Serono
05/31/2008
CONTACT: Dr. Raphaela Farrenkopf of Merck Serono, +49-6151-72-2274
Web site: http://www.merckserono.net
http://www.merck.de
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