Contact : Anne Bancillon : + 33 6 86 31 03 89
- 430 abstracts from studies involving Taxotere® or Eloxatin® accepted at the meetings scientific sessions -
Paris, May 30, 2006 Sanofi-aventis announced today that key study results from the companys leading chemotherapeutic agents, Eloxatin® (oxaliplatin injection) and Taxotere® (docetaxel) Injection Concentrate, will be presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia. A total of 430 abstracts from studies involving Taxotere® or Eloxatin® (185 and 245 respectively) were accepted at the meetings scientific sessions, including four Eloxatin® abstracts and three Taxotere® abstracts for podium presentations. The ASCO meeting begins on June 2 and runs through June 6.
In particular, significant studies include the use of Eloxatin®-based regimens in patients with pancreatic cancer and patients with stomach (gastric) cancer, two tumor types under investigation, as well as patients with colorectal cancer. Key Taxotere® study results include its use in treating patients with lung cancer, breast cancer and head and neck cancer, a not yet approved indication. Additional study findings on the use of Taxotere® and Eloxatin® in other indications and/or in combination with other agents, including biologic compounds, will be presented.
Among the key data to be presented at the meeting during podium presentations or poster discussions are the following:
Key Eloxatin® clinical studies:
Abstract #LBA4004 Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion [FDR]) versus gemcitabine + oxaliplatin (GEMOX) in patients with advanced pancreatic cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study ECOG6201. Sunday, June 4, 3:15 3:30, Bldg C, Level 1, Hall C1, Oral Presentation.
Abstract #LBA4017 Randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer: The REAL 2 trial. Monday, June 5, 11:30 11:45, Bldg C, Level 1, Hall C3, Oral Presentation.
Abstract #3510 Safety and efficacy of oxaliplatin/fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer (mCRC): Final analysis of the TREE-Study. Monday, June 5, 4:45 5:00, Bldg C, Level 1, Hall C4, Oral Presentation.
Abstract #3504 OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC). A GERCOR study. Monday, June 5, 3:00 3:15, Bldg C, Level 1, Hall C4, Oral Presentation.
Key Taxotere® clinical studies:
Head and Neck Cancer
# Special Session : A Phase III Trial of docetaxel, cisplatin and 5-Fluorouracil (TPF) versus cisplatin and 5-Fluorouracil (PF) Induction chemotherapy (IC) followed by Chemoradiotherapy (CRT) in Patients with Locally Advanced Squamous Cell carcinoma of the head and heck (SCCHN) (TAX 324) Sunday, June 4, 2006 1:00 PM - 1:30 PM, Bldg C, Level 1, Hall C4, Oral presentation.
Abstract #7034 Comparison of docetaxel and vincaalkaloid, alone or in combination with other chemotherapy agents, in the first-line treatment of advanced non-small cell lung cancer (NSCLC): A meta-analysis. Saturday, June 3, 8:00 12:00, Bldg A, Level 3, Room A314, Poster Discussion.
Metastatic Breast Cancer
Abstract #LBA516 A randomized phase III trial of trastuzumab plus docetaxel with or without carboplatin first line in HER2 positive metastatic breast cancer (MBC): Main Time to Progression (TTP) analysis. Sunday, June 4, 10:45 11:00, Bldg C, Level 1, Hall C1, Oral Presentation.
Adjuvant Breast Cancer
Abstract #LBA519 Docetaxel (T) given concurrently with or sequentially to anthracycline-based (A) adjuvant therapy (adjRx) for patients (pts) with node-positive (N+) breast cancer (BrCa), in comparison with non-T adjRx: First results of the BIG 2-98 Trial at 5 years median follow-up (MFU). Monday, June 5, 9:00 9:15, Bldg C, Level 1, Hall C1, Oral Presentation.
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® is currently not approved in pancreatic cancer or in stomach (gastric) cancer.
Eloxatin® was developed in association with Debiopharm SA and is currently marketed by
sanofi-aventis in more than 60 countries.
Taxotere® is currently approved in 4 different indications:
In Breast Cancer:
In the United States and in Europe, Taxotere® is approved to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. It is also approved in Europe in combination with doxorubicine for patients who have received prior cytotoxic therapy for this condition and in combination with capecitabine after failure of cytotoxic therapy which would have included anthracycline. In the adjuvant setting (post surgery) it is approved in the US and in Europe in combination with doxorubicin and cyclophosphamide (TAC regimen) for the treatment of patients with operable, node-positive breast cancer. Finally, in Europe, Taxotere® is approved in combination with trastuzumab for the treatment of patients with metastatic breast cancer- overexpressing Her2 receptor.
In Lung Cancer:
In the US and in Europe Taxotere®, in combination with cisplatin, is approved for the treatment of patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy, and it also is approved, as a single agent, for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.
In Prostate cancer:
Taxotere® is approved for use in combination with prednisone as a treatment for
androgen-independent (hormone-refractory) metastatic prostate cancer in the US and in Europe.
In Gastric (Stomach) cancer
The FDA and the the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) approved in march 2005, the use of Taxotere® Injection Concentrate in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastro oesophageal (GE) junction, who have not received prior chemotherapy for advanced disease.
Sanofi-aventis is the worlds third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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