BRIDGEWATER, N.J., Jan. 26 /PRNewswire-FirstCall/ -- The sanofi-aventis
Group announced today that important data from four Eloxatin(R) (oxaliplatin
for injection)-related studies will be presented at the Gastrointestinal
Cancers Symposium, co-sponsored by the American Society of Clinical Oncology
(ASCO), the American Gastroenterological Association (AGA), the American
Society for Therapeutic Radiology and Oncology (ASTRO), and the Society of
Surgical Oncology (SSO), January 27-29, in Hollywood, Florida.
An on-site press conference highlighting the symposium's "featured
research," which includes two ELOXATIN-based studies, will be held on
Thursday, January 27, at 11:00 am ET, in room Diplomat II at the Westin
Diplomat Resort and Spa.
Members of the press who wish to participate in the press conference, but
are not on-site, may join by phone. Please contact ASCO at 703-519-1422 for
details.
ELOXATIN-based studies featured at the press conference include:
Oxaliplatin/5FU/LV in the adjuvant treatment of stage II and stage III
Colon Cancer: efficacy results with a median follow up of 4 years
Aimery de Gramont, MD, of the Saint-Antoine Hospital, will present 4-year
follow-up data from the MOSAIC trial. MOSAIC was designed to demonstrate an
increase in disease-free survival (DFS) in stage II and III colon cancer
patients among 2,246 patients randomly assigned to receive conventional
chemotherapy, known as LV5FU2 or the ELOXATIN-based regimen FOLFOX4. Study
results with 3-year follow-up were published in the New England Journal of
Medicine in 2004.
Major new study assessing the efficacy of FOLFOX4 in combination with
high-dose bevacizumab in patients with advanced colorectal cancer
Bruce J. Giantonio, MD, of the University of Pennsylvania Health System,
will present results from E3200, a phase III randomized study of ELOXATIN,
fluorouracil, and leucovorin calcium with or without bevacizumab versus
bevacizumab alone in patients with previously treated advanced or metastatic
colorectal adenocarcinoma. The study was sponsored by the National Cancer
Institute and conducted by a network of researchers led by the Eastern
Cooperative Oncology Group.
Additional studies featured in abstract/poster sessions on Saturday,
January 29, include:
Bevacizumab (B) with oxaliplatin (O)-based chemotherapy in the first-line
therapy of metastatic colorectal cancer (mCRC): preliminary results of the
randomized "TREE-2" trial
Howard Hochster, MD, of the New York University School of Medicine, will
present data from the first study to assess the safety and tolerability of
bolus, infusional and oral Eloxatin(R) (oxaliplatin for injection) -based
regimens combined with bevacizumab for the first line treatment of metastatic
colorectal cancer. Updated data, including response results will be
presented.
Cost-effectiveness analysis of oxaliplatin/5-FU/LV in adjuvant treatment
of colon cancer in the U.S
Researchers will present an analysis evaluating the long-term cost-
effectiveness of using FOLFOX4, from a U.S. Medicare perspective.
About ELOXATIN
In Europe
ELOXATIN received approval in France for the second-line treatment of
metastatic colorectal cancer in April 1996, and as a first-line treatment in
April 1998. In July 1999, ELOXATIN was approved for the first-line treatment
of advanced colorectal cancer in major European countries through the mutual
recognition procedure, France being the Reference Member State.
ELOXATIN successfully completed a Mutual Recognition Procedure in Europe
in December 2003, which allowed the product to be marketed for the treatment
of metastatic colorectal cancer in combination with 5-fluorouracil and folinic
acid (i.e., in first- and second-line treatment).
In September 2004, the indication for ELOXATIN was extended in Europe,
again through the Mutual Recognition Procedure, to include the "Adjuvant
treatment of stage III (Dukes' C) colon cancer after complete resection of
primary tumor."
In the United States
In the United States, ELOXATIN, in combination with infusional 5-FU/LV,
received approval on January 9, 2004, for the first-line treatment of advanced
carcinoma of the colon or rectum (ie, first therapy for patients with
metastatic colorectal cancer). This same ELOXATIN-based combination had
initially (August 2002) received FDA approval for second-line treatment, (ie,
therapy for previously treated patients with metastatic colorectal cancer).
On November 4, 2004, this ELOXATIN-based regimen was approved for the
adjuvant treatment of stage III (Dukes' C) colon cancer after complete
resection of the primary tumor.
ELOXATIN was developed in association with Debiopharm SA and is currently
marketed by the sanofi-aventis Group in more than 60 countries.
Bevacizumab is manufactured by Genentech, Inc., and is used with
intravenous 5-FU-based chemotherapy in the first-line treatment of patients
with metastatic cancer of the colon or rectum.
Colorectal Cancer as a Leading Cause of Death
Every year, about one million new cases of colorectal cancer are diagnosed
worldwide(1). About 194,000 new cases are detected in Europe and 150,000 in
the United States. According to the American Cancer Society, colorectal cancer
is the second leading cause of cancer-related death in the United States,
accounting for 10% to 15% of all cancer deaths. Over a lifetime, about 1 in 18
people develop colorectal cancer and more than 56,000 people die from it in
the United States each year(2). In Europe, 94,000 people die from colorectal
cancer each year(3).
Colorectal cancer is cancer that begins in the cells that line the colon
or rectum. When these cancer cells spread away from the colon to distant
locations in the body, the cancer is referred to as metastatic. Cancer cells
may spread, or metastasize, through the blood or lymphatic system, or directly
grow into tissues adjacent to the original cancer.
A diagnosis of colorectal cancer is associated with a stage, which
reflects the extent of the cancer and whether it has spread. Patients with
colorectal cancer that has spread to distant organs or tissues are said to
have advanced, or metastatic, colorectal cancer, also known as stage IV
colorectal cancer. Patients with advanced colorectal cancer can now more
confidently expect to live twice as long as they could only a few years ago.
Further Development in Other Types of Cancer
An extensive worldwide clinical development program is ongoing to explore
the potential benefits of Eloxatin(R) (oxaliplatin for injection) in other
types of cancer.
Clinical Considerations for ELOXATIN
ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for
adjuvant treatment of stage III colon cancer patients who have undergone
complete resection of the primary tumor. The indication is based on an
improvement in disease-free survival, with no demonstrated benefit in overall
survival after a median follow-up of 4 years.
ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for
the treatment of advanced carcinoma of the colon or rectum.
Eloxatin (R) (oxaliplatin for injection) should be administered under the
supervision of a physician experienced in the use of cancer chemotherapeutic
agents. Appropriate management of therapy and complications is possible only
when adequate diagnostic and treatment facilities are readily available.
Anaphylactic-like reactions to ELOXATIN have been reported and may occur
within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and
antihistamines have been employed to alleviate symptoms, and discontinuation
of ELOXATIN therapy may be required.
Adjuvant Colon Cancer Setting
The incidence of grade 3 or grade 4 events was 70% and 31% on the
Eloxatin(R) (oxaliplatin for injection) combination arm and infusional 5-FU/LV
arm, respectively. Granulocytopenia, paresthesia, diarrhea, vomiting, and
nausea were the most common grade 3 or 4 adverse events. Paresthesia was seen
in 92% of patients on the ELOXATIN combination; 21% had residual paresthesia
at 18-month follow-up. Three percent and 0.5% had grade 2 and 3 paresthesias,
respectively, at 18-month follow-up. Grade 3 or 4 hypersensitivity was noted
in 3% and may require discontinuation of therapy. Hepatotoxicity, evidenced by
increase in transaminases (57% vs 34%) and alkaline phosphatases (42% vs 20%),
was observed more commonly in the ELOXATIN arm. The incidence of increased
bilirubin was similar on both arms. Hepatic vascular disorders should be
considered and investigated if abnormal liver function tests or portal
hypertension are present and cannot be explained by liver metastases or other
known etiologies.
Advanced Colorectal Cancer Setting
Fatigue, neuropathy, nausea, vomiting, diarrhea, stomatitis, neutropenia,
and thrombocytopenia were the more common adverse events. Neither febrile
neutropenia nor requirement for platelet transfusion was increased as compared
to treatment with irinotecan plus bolus 5-FU/LV. ELOXATIN has been associated
with pulmonary fibrosis (<1% of study patients), which may be fatal. There
have been reports while on study from clinical trials and from postmarketing
surveillance of prolonged prothrombin time and INR occasionally associated
with hemorrhage in patients who received ELOXATIN plus 5-FU/LV while on
anticoagulants. Patients requiring oral anticoagulants may require closer
monitoring. Hypersensitivity has been observed (<2% grade 3/4) in clinical
studies and trials. It was usually managed with standard epinephrine,
corticosteroid, and antihistamine therapy, and may require discontinuation of
ELOXATIN therapy.
Full prescribing information, including clinical trial information,
safety, dosing, drug-drug interactions, and contraindications, is available
at: http://www.fda.gov/cder/foi/label/2004/021492s004lbl.pdf .
About sanofi-aventis
The sanofi-aventis Group is the world's 3rd largest pharmaceutical
company, ranking number 1 in Europe. Backed by a world-class R&D organization,
sanofi-aventis is developing leading positions in seven major therapeutic
areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous
system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
The sanofi-aventis Group conducts business in the U.S. through its
affiliates Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995. Forward-looking statements
are statements that are not historical facts. These statements include
financial projections and estimates and their underlying assumptions,
statements regarding plans, objectives and expectations with respect to future
operations, products and services, and statements regarding future
performance. Forward-looking statements are generally identified by the words
"expect," "anticipates," "believes," "intends," "estimates" and similar
expressions. Although sanofi-aventis' management believes that the
expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of sanofi-aventis, that could cause
actual results and developments to differ materially from those expressed in,
or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include those discussed or identified in the
public filings with the SEC and the AMF made by sanofi-aventis and Aventis,
including those listed under "Forward-Looking Statements" and "Risk Factors"
in sanofi-aventis's annual report on Form 20-F for the year ended December 31,
2003 and those listed under "Cautionary Statement Regarding Forward-Looking
Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the
year ended December 31, 2003. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise any
forward-looking information or statements.
(1) Boyle P, Leon ME. Epidemiology of colorectal cancer. Br Med Bull.
2002;64:1-25.
(2) American Cancer Society. Cancer Facts & Figures 2004. Available at:
http://www.cancer.org/downloads/STT/CAFF_finalPWSecured.pdf. Accessed
September 7, 2004.
(3) GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide.
IARC Press. September 30, 2004.
U.S. Contact:
Marisol Peron
908-243-7592,
Marisol.Peron@sanofi-aventis.com
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