New Data on Cetuximab (Erbitux(TM)/C225)
ORLANDO, Fla., and DARMSTADT, Germany, May 21 /PRNewswire/ -- New data on
drugs in Merck KGaA's oncology pipeline were presented in seven separate
abstracts at the 38th annual meeting of the American Society of Clinical
Oncology in Orlando, May 18-21, 2002.
The abstracts described different steps in the development of various
investigational drugs within Merck KGaA's strategic concept of targeted cancer
treatments. Merck KGaA is developing four strategic areas of targeted cancer
treatments -- monoclonal antibodies, therapeutic cancer vaccines,
immunocytokines and angiogenesis inhibitors.
Among the seven abstracts presented at ASCO, two focused on the monoclonal
antibody cetuximab (Erbitux(TM)/C225), the most advanced product in Merck's
extensive oncology pipeline.
Cetuximab is an investigational monoclonal antibody designed to target and
block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the
surface of certain cancer cells. Cetuximab is currently being investigated
for the treatment of head and neck and colorectal cancers as the main
indications. Other studies are being conducted in non-small cell lung cancer
and pancreatic cancer. The abstracts presented at ASCO continue to
demonstrate the clinical benefits of cetuximab in a number of tumor types
expressing EGFR.
Dr. Jose Baselga and a group of researchers from several European
countries presented data about cetuximab in combination with cisplatin or
carboplatin in 75 patients with recurrent/metastatic squamous cell carcinoma
of the head and neck failing treatment with cisplatin or carboplatin (Oral
Presentation, #900). The addition of cetuximab to the previously ineffective
chemotherapies resulted in an overall response rate of 10.7%. Additional 36%
of patients showed stabilization of disease for more than six weeks. The
overall rate of disease control (partial response plus stable disease) is
46.7%.
"The response rate is not unexpected and it represents a clinical benefit
when you consider the extremely poor prognosis for patients with advanced
metastatic squamous cell carcinoma of the head and neck being heavily
pre-treated with radio- and chemotherapy. The high number of patients with
stabilization of disease (36%) after demonstrating a clear progression under
platinum chemotherapy and the median survival rate of about five months in
this population is another indication of the activity of this drug. The study
design is complex and assessment of response is difficult in this patient
population," said Dr. Jose Baselga, Vall d'Hebron Hospital, Barcelona. "We
are currently assessing cetuximab as a monotherapy to investigate if we can
achieve the same effect without the toxicity of the combination therapy with
cisplatin," said Dr. Baselga.
Dr. P. Schoeffski and a group of researchers from the German cities
Hannover, Ulm, Dresden and Darmstadt presented data from a phase I study of
cetuximab plus irinotecan (CPT-11) plus infusional 5FU/folinic acid in
patients receiving first line treatment for metastatic colorectal cancer that
expresses epidermal growth factor receptor (EGFR) (Poster/Discussion #633).
The study, which had 19 patients enrolled, showed that cetuximab plus
irinotecan plus infusional 5FU/folinic acid has an acceptable safety profile
and can produce an objective response in first-line treatment of patients with
metastatic colorectal cancer expressing EGFR.
"We are encouraged by the early signs of acceptable safety and evidence of
activity of cetuximab in first line treatment in combination with irinotecan
and 5FU/ folinic acid," said Dr. Schoeffski, who presented the study.
The abstracts about cetuximab at ASCO 2002 showed that overall the drug
has evidence of activity and a predictable side effect profile. The most
clinically relevant side effects related to cetuximab are cases of acne-like
skin rash and mild allergic reactions. There are no cases of diarrhea or
neutropenia that are dose limiting.
Merck licensed the rights to develop and market cetuximab outside of North
America from ImClone Systems Incorporated of New York (Nasdaq: IMCL) in 1998.
Merck KGaA plans to file its application for European approval of
cetuximab with the European Medicines Evaluation Agency (EMEA) in the first
half of 2003 using a data package including colorectal cancer as well as
head-and-neck cancer. Merck KGaA is expecting Europe-wide approval in 2004.
Other Merck KGaA abstracts presented at ASCO included data about another
monoclonal antibody EMD 72000 (Poster #378); two reports about EGFR expression
(Abstract only/No presentation #2549 and Poster/Discussion #578); data from a
phase I study of the anti-angiogenic alpha nu beta 3 and alpha nu beta 5
integrin antagonist EMD 121974 (Poster #110); and data from a phase I/IIb
trial of the immunocytokine hu.18-IL2 in patients with GD positive tumors
(Poster # 62).
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With more than 34,000 employees in 55 countries, the Merck Group generated
sales of EUR 7.5 billion in 2001. Founded in 1668 in Darmstadt, Germany, the
company aims to be a world leader in its core businesses of pharmaceuticals
and chemicals. The Merck Group strongly believes the key to its long-term
business success is innovative products created by entrepreneurial and
talented employees. Merck groups its operating activities under Merck KGaA,
in which the Merck family holds 74% and the remaining 26% is publicly traded.
The former U.S. subsidiary, Merck & Co., has been a completely independent
company since 1917.
SOURCE Merck KGaA
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CONTACT:
Dr. Hartmut Vennen, +49-0-61-51-72-23-86m for
Merck KGaA; or Phyllis Carter - On Site at ASCO - Cell,
+49-0-175-156-7027, or Cell (US), +1-407-766-1537
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