Scientific Data Presented at ASCO Annual Meeting Evaluating ERBITUX(TM) (Cetuximab) in Head and Neck Cancer (Abstracts 5502 and 5513)
Clinical Oncology (ASCO) 40th Annual Meeting. The studies assessed ERBITUX as a
patients with recurrent and/or metastatic SCCHN. The companies plan to discuss
and Drug Administration (FDA) and the European Medicines Agency (EMEA).
to platinum-based chemotherapy.
percent. The disease control rate was 45.6 percent (95% CI: 35.8-55.7), which
was defined as partial response (12.6%) plus stable disease (33%). Median time
to progression was 2.3 months, median survival was 5.9 months, and median
duration of response was 5.9 months.
In 53 patients whose disease progressed during ERBITUX monotherapy who then
received ERBITUX in combination with platinum-based chemotherapy, there were 14
patients with stable disease, 14 patients with progressive disease and 25
patients were not assessable. Median time to progression in this group was 50
days.
The most commonly reported adverse events occurring in more than 20 percent of
patients, regardless of relationship to therapy, included acne-like rash (69%;
grade 3/4, 1%) and fatigue (24%; grade 3/4, 4%). Additional grade 3/4 adverse
events included vomiting (2%), nausea (1%) and diarrhea (1%). There was one
treatment-related death due to infusion reaction.
Abstract
#5513A randomized phase I study conducted by Merck KGaA (EMR-008) evaluated the
safety and tolerability of ERBITUX in combination with one of three doses of
5-FU and either cisplatin or carboplatin in 53 patients with recurrent and/or
metastatic SCCHN.
An efficacy analysis of the pooled arms demonstrated a disease control rate of
69.8 percent (95% CI: 55.7-81.7), which was defined as complete response plus
partial response plus stable disease. The overall response rate was 35.9 percent
(95% CI: 23.1-50.2). Median time to progression was 155 days (95% CI: 127-186),
and median survival was 297 days (95% CI: 242-418).
The most frequent adverse event (any grade) was skin reaction (74%, cisplatin
group; 92%, carboplatin group). The most frequent grade 3/4 adverse events in
the group receiving cisplatin (n=27) regardless of relationship to study
medication were leucopenia (56%), asthenia (33%), nausea/vomiting (26%),
mucositis (15%), anemia (15%), thrombocytopenia (11%), diarrhea (7%) and
anorexia (4%). Among patients receiving carboplatin (n=25), the most frequent
grade 3/4 adverse events regardless of relationship to study medication were
leucopenia (20%), thrombocytopenia (20%), asthenia (16%), mucositis (12%),
anemia (8%), acne-like reaction (4%) and skin reaction (4%).
ERBITUX(TM) (Cetuximab) Approved Indication
ERBITUX is approved by the FDA for use in combination with irinotecan in the
treatment of patients with EGFR-expressing, metastatic colorectal cancer who are
refractory to irinotecan-based chemotherapy and for use as a single agent in the
treatment of patients with EGFR-expressing, metastatic colorectal cancer who are
intolerant to irinotecan-based chemotherapy. The effectiveness of ERBITUX for
the treatment of colorectal cancer is based on objective response rates.
Currently, no data are available that demonstrate an improvement in
disease-related symptoms or increased survival with ERBITUX.
Outside the U.S., Merck KGaA, Darmstadt, Germany, gained approval for use of
ERBITUX in combination with irinotecan in patients with EGFR-expressing
metastatic colorectal cancer who have failed prior irinotecan therapy in
Switzerland in December 2003, with EU approval expected in June 2004.
In May 2004, Merck KGaA also received approval for ERBITUX in Argentina and
Mexico for use in combination with irinotecan or as a single agent in patients
with EGFR-expressing metastatic colorectal cancer after failure of
irinotecan-including cytotoxic therapy.
ERBITUX Important Safety Information
Severe infusion reactions, rarely fatal and characterized by rapid onset of
airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and
hypotension, have occurred (3%) with the administration of ERBITUX. Most
reactions (90%) are associated with the first infusion of ERBITUX despite the
use of prophylactic antihistamines.
Severe cases of interstitial lung disease (ILD), which was fatal in one case,
occurred in less than 0.5% of patients receiving ERBITUX.
Dermatologic toxicities, including acneform rash (12% grade 3-4), skin drying
and fissuring, and inflammatory or infectious sequelae (e.g. blepharitis,
cheilitis, cellulitis, cyst) were reported. Sun exposure may exacerbate these
effects.
Other serious adverse events associated with ERBITUX in clinical trials were
fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%),
dehydration (5% in patients receiving ERBITUX plus irinotecan, 2% receiving
monotherapy) and diarrhea (6% in patients receiving ERBITUX plus irinotecan, 0%
with monotherapy).
Additional common adverse events seen in patients receiving ERBITUX plus
irinotecan (n=354) or ERBITUX monotherapy (n=279) were acneform rash (88%/90%),
asthenia/malaise (73%/49%), diarrhea (72%/28%), nausea (55%/29%), abdominal pain
(45%/25%), vomiting (41%/25%), fever (34%/33%) and constipation (30%/28%).
Full prescribing information is available upon request, or at
www.ERBITUX.com.Background Information
ERBITUX binds specifically to epidermal growth factor receptor (EGFR, HER1,
c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding
of epidermal growth factor (EGF) and other ligands, such as transforming growth
factor-alpha. The EGFR is constitutively expressed in many normal epithelial
tissues, including the skin and hair follicle. Over- expression of EGFR is also
detected in many human cancers including those of the colon and rectum.
According to the American Cancer Society, approximately 40,000 Americans will be
diagnosed with oral, head and neck cancer this year, including cancers of the
tongue, mouth, pharynx, and larynx. More than 11,000 will die from the disease
in 2004. Approximately 70,000 new cases are diagnosed annually in Europe, with
more than 25,000 deaths each year. Treatment for head and neck cancer may
include surgery, radiation therapy and chemotherapy or some combination of
these.
About ImClone Systems Incorporated
ImClone Systems Incorporated is committed to advancing oncology care by
developing and commercializing a portfolio of targeted biologic treatments
designed to address the medical needs of patients with a variety of cancers. The
Company's three programs include growth factor blockers, angiogenesis inhibitors
and cancer vaccines. ImClone Systems' strategy is to become a fully integrated
biopharmaceutical company, taking its development programs from the research
stage to the market. ImClone Systems' headquarters and research operations are
located in New York City, with additional administration and manufacturing
facilities in Branchburg, New Jersey.
Certain matters discussed in this news release may constitute forward- looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995 and the Federal securities laws. Although the company believes that the
expectations reflected in such forward-looking statements are based upon
reasonable assumptions it can give no assurance that its expectations will be
achieved. Forward-looking information is subject to certain risks, trends and
uncertainties that could cause actual results to differ materially from those
projected. Many of these factors are beyond the company's ability to control or
predict. Important factors that may cause actual results to differ materially
and could impact the company and the statements contained in this news release
can be found in the company's filings with the Securities and Exchange
Commission including quarterly reports on Form 10-Q, current reports on Form 8-K
and annual reports on Form 10-K. For forward-looking statements in this news
release, the company claims the protection of the safe harbor for
forward-looking statements contained in the Private Securities Litigation Reform
Act of 1995. The company assumes no obligation to update or supplement any
forward-looking statements whether as a result of new information, future events
or otherwise.
About Bristol-Myers Squibb
Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive
exploration of innovative cancer fighting therapies designed to extend and
enhance the lives of patients living with cancer. More than 40 years ago,
Bristol-Myers Squibb built a unified vision for the future of cancer treatment.
With expertise, dedication and resolve, that vision led to the development of a
diverse global portfolio of anti-cancer therapies that are an important
cornerstone of care today. Hundreds of scientists at Bristol-Myers Squibb's
Pharmaceutical Research Institute are studying ways to improve current cancer
treatments and identify better, more effective medicines for the future.
Bristol-Myers Squibb is a global pharmaceutical and related health care products
company whose mission is to extend and enhance human life.
This press release contains "forward-looking statements" as that term is defined
in the Private Securities Litigation Reform Act of 1995 regarding product
development. Such forward-looking statements are based on current expectations
and involve inherent risks and uncertainties, including factors that could
delay, divert or change any of them, and could cause actual outcomes and results
to differ materially from current expectations. No forward-looking statement can
be guaranteed. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Bristol-Myers
Squibb's business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year
ended December 31, 2003 and in our Quarterly Reports on Form 10-Q. Bristol-Myers
Squibb undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or otherwise.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a global pharmaceutical and chemical company
with sales of EUR 7.2 billion in 2003, a history that began in 1668, and a
future shaped by 28,300 employees in 56 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 a 74 percent
interest and free shareholders own the remaining 26 percent. The former U.S.
subsidiary, Merck & Co., has been completely independent of the Merck Group
since 1917.
Merck KGaA, Darmstadt, Germany, licensed the right to market ERBITUX outside the
U.S. and Canada from ImClone Systems Incorporated of New York in 1998. In Japan,
Merck KGaA has co-exclusive marketing rights with ImClone Systems.
Notes to editors:
Data from EMR-008 (Abstract 5513) were presented Sunday, June 6, 1:00 PM CDT
during a poster discussion session on head and neck cancer.
Data from EMR-016 (Abstract 5502) were presented Tuesday, June 8, 10:45 AM CDT
during an oral presentation session on head and neck cancer.
SOURCE ImClone Systems Incorporated; Merck KGaA; Bristol-Myers Squibb Company
CONTACT: Andrea Rabney, Corporate Communications, +1-646-638-5058,
Andrea.Rabney@imclone.com, or David Pitts, Corporate Communications
+1-646-638-5058, David.Pitts@imclone.com, or Stefania Bethlen, Corporate
Communications, IR, +1-646-638-5058, Stefania.Bethlen@imclone.com, all of
ImClone Systems Incorporated; Tracy Furey, Corporate Affairs, +1-609-252-3208,
Tracy.Furey@bms.com, or Susan Walser, Investor Relations, +1-212-546-4631,
Susan.walser@bms.com, or John Elicker, Investor Relations, +1-212-546-3775,
john.elicker@bms.com, or Kathy Baum, Corporate Affairs, +1-609-252-4227,
Kathy.Baum@bms.com, all of Bristol-Myers Squibb; or Phyllis Carter, Corporate
Media Relations, Merck KGaA, +49-6151-72-7144, Phyllis.Carter@merck.de
URL:
www.ERBITUX.com 
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