Two Landmark Studies of Taxotere(reg) in Prostate Cancer Highlighted in American Society of Clinical Oncology Plenary Session

Main Category: Cancer / Oncology
Also Included In: Prostate / Prostate Cancer
Article Date: 26 May 2004 - 0:00 PDT

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Aventis announced today that two landmark Phase III studies of Taxotere (docetaxel) Injection Concentrate in men with androgen-independent (hormone-refractory) metastatic prostate cancer have been selected for presentation at the Plenary Session of the 2004 annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA.[i]A, [ii]A

The abstracts are two of only five selected for presentation during the meeting's plenary session on Monday, June 7, in Hall F of the Ernest N. Morial Convention Center. The plenary session is considered the meeting's premier scientific session, as it features prominent data selected by the ASCO Program Committee. Additional data from a clinical trial about Taxotere involving cancer of the head and neck will also be presented at ASCO. [iii]A

Abstract #3, Monday, June 7, 2:45 - 3:00 PM (CDT), Hall F[iv]A

Results from SWOG 9916, a randomized Phase III multi-center trial comparing Taxotere plus estramustine to mitoxantrone plus prednisone in men with androgen-independent (hormone-refractory) metastatic prostate cancer will be presented by Daniel P. Petrylak, MD, Director, Genitourinary Oncology Program, Columbia Presbyterian Medical Center. The study was conducted in cooperation with the Southwest Oncology Group. [i]A

Abstract #4, Monday, June 7, 3:00 - 3:15 PM (CDT), Hall F[v]A

A second presentation given by Mario Eisenberger, MD, Dale Hughes Professor of Oncology and Urology at the Johns Hopkins Kimmel Cancer Center, will feature data from TAX 327, a multicenter phase III trial comparing the combination of Taxotere and prednisone to the current standard treatment regimen of mitoxantrone plus prednisone in patients with androgen-independent (hormone-refractory) metastatic prostate cancer.[i]A

Abstract #5508, Tuesday, June 8, 11:45 - 12:00 PM (CDT), Room O24

In addition, Jan Baptist Vermorken, MD, PhD, Department of Oncology, University Hospital Antwerp Belgium, will present data from TAX 323, a Phase III clinical trial comparing Taxotere plus cisplatin and infusional 5-fluorouracil to standard cisplatin and infusional 5-fluorouracil in patients with nonresectable, locally advanced, squamous cell carcinoma of the head and neck (LA-SCCHN).[vi]A

About Prostate Cancer

Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer mortality among men.[vii]A In the United States, more than 230,000 men will be diagnosed with prostate cancer this year, and more than 29,900 will die of the disease.[viii]A

Current therapy for advanced prostate cancer is hormonal manipulation (i.e., blockage of androgen hormones like testosterone that would otherwise stimulate the growth of prostate cancer cells).[ix]A However, the effects of this treatment typically last between 24 and 36 months, at which time patients may become refractory to hormonal therapy and be considered candidates for chemotherapy,[x]A such as Taxotere.

About Taxotere

Taxotere is a key growth driver for Aventis and is the foundation of the company's oncology franchise. Taxotere is indicated for treatment of metastatic breast cancer and non-small cell lung cancer, and is being studied extensively in clinical trials for safety and efficacy in head & neck, early-stage breast and gastric cancers.

Additional Taxotere submissions to regulatory authorities for gastric cancer are planned for the second half of the year and head & neck cancer is planned for 2005. On May 19, 2004, the U.S. Food and Drug Administration granted approval of Taxotere for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.[xi]A In 2003, Taxotere generated worldwide sales of over � 1.3 billion.

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of � 16.79 billion, invested � 2.86 billion in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.

Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de R�f�rence"- on file with the "Autorit� des march�s financiers" in France.

Pursuant to Article 7 of the COB Regulation no. 2002-04, this press release was transmitted to the Autorit� des march�s financiers before its release.

REFERENCES

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[i] "A multicenter phase III comparison of docetaxel (D) + prenisone (P) and mitoxantrone (MTZ) = P in patients with hormone-refractory prostate cancer" as posted on the American Society of Clinical Oncology web site at http://www.asco.org/ac/1,1003,_12-002557-00_18-0018225,00.asp

[ii] "SWOG 9916: Randomized phase III trial of docetaxel (D)/estramustine (E) versus mitoxantrone(M)/prednisone(p) in men with androgen-independent prostate cancer (AIPCA)" as posted on the American Society of Clinical Oncology web site at http://www.asco.org/ac/1,1003,_12-002557-00_18-0019810,00.asp

[iii] "Head and Neck Cancer: Oral Presentations," as posted on the American Society of Clinical Oncology web site at http://www.asco.org/ac/1,1003,_12-002556-00_18-004781,00.asp

[iv] "A multicenter phase III comparison of docetaxel (D) + prenisone (P) and mitoxantrone (MTZ) = P in patients with hormone-refractory prostate cancer" as posted on the American Society of Clinical Oncology web site at http://www.asco.org/ac/1,1003,_12-002557-00_18-0018225,00.asp

[v] "SWOG 9916: Randomized phase III trial of docetaxel (D)/estramustine (E) versus mitoxantrone(M)/prednisone(p) in men with androgen-independent prostate cancer (AIPCA)" as posted on the American Society of Clinical Oncology web site at http://www.asco.org/ac/1,1003,_12-002557-00_18-0019810,00.asp

[vi] Vermoken, JB; Remenar, E; vanHerpen, C; Germa-Lluch, J; Degardin, M; Stewart, S; Schollen, K; Gorlia, T; and Bernier, J. "Standard cisplatin/infusional 5-fluorouracil (PF) vs. docetaxel (T) plus PF (TPF) as neoadjuvant chemotherapy for nonresectable locally advanced squanous cell carcinoma of the head and neck (LA-SCCHN): A phase III trial of the EORTC Head and Neck Cancer Group" [Abstract] American Clinical Society of Oncology Annual Meeting 2004.

[vii] "Adult Conditions: Prostate; Causes, Natural History & Diagnosis of Prostate Cancer" as posted on the American Urological Association web site at http://www.urologyhealth.org/adult/index.cfm?cat=09&topic=39

[viii] American Cancer Society. Cancer Facts & Figures 2004, p. 16.

[ix] "Hormone Therapy for Prostate Cancer" as posted on the American Urological Association Web site at http://www.urologyhealth.org/adult/index.cfm?cat=09&topic=90.

[x] "Hormone Therapy for Prostate Cancer" as posted on the American Urological Association Web site at http://www.urologyhealth.org/adult/index.cfm?cat=09&topic=90.

[xi] "Aventis Receives FDA Approval for Taxotere � in Prostate Cancer." Posted on PR Newswire, May 19, 2004.

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