Healthcare Industry News: Sanofi-aventis
News Release - June 3, 2007
S-1, a Novel Oral Fluoropyrimidine, When Combined With Cisplatin, Demonstrates Significant Improvement in Overall Survival of Advanced Gastric Cancer Patients Over S-1 AlonePositive results of the "SPIRITS" Study Reported in Oral Presentation at ASCO 2007
CHICAGO, June 3 (HSMN NewsFeed) -- Taiho and Sanofi-aventis announced today the results of a phase III trial in advanced gastric cancer, which shows that the combination of the investigational oral fluoropyrimidine S-1 with cisplatin significantly reduces the risk of death by 22.6% (HR: 0.774; 95% CI [0.608-0.985]) over S-1 alone. Findings from the "SPIRITS" study, a Japanese multicenter, randomized, open label phase III trial, were presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology in Chicago, IL.
The overall survival with a two-year follow-up was significantly higher in the S-1/cisplatin combination arm over S-1 alone (in median, respectively 13 months versus 11 months, p=0.036). The overall Response Rate (RR) is also significantly better among patients treated with S-1 and cisplatin (54% of patients treated with the combination responded to treatment compared with 31.1% with S-1 alone, p=0.001).
There were more grade 3/4 hematological and gastro-intestinal (anorexia/nausea) toxicities when cisplatin was combined with S-1, and there were much lower incidences of the same side effects with S-1 alone.
"This study demonstrates that the combination of S-1 and cisplatin brings to the patient with advanced gastric cancer an acceptable benefit/risk ratio," presented Dr. Hiroyuki Narahara, study investigator. "The results confirm previous data we've seen in Japan, where S-1 has been on the market for the treatment of gastric cancer for eight years now."
About the "SPIRITS" Study
The "SPIRITS" study is part of an investigational ongoing program testing S-1 in combination with different anti-cancer drugs in advanced gastric cancer. This study was designed to evaluate the efficacy of S-1 combined with cisplatin compared to S-1 alone in patients with unresectable or recurrent advanced gastric cancer who have never been treated with chemotherapy.
Three hundred and five patients were randomized to receive either oral S-1 twice daily for 28 days followed by a 14-day rest period, or oral S-1 twice daily for 21 days plus IV cisplatin on the eighth day of treatment, followed by the 14-day rest period. The dose of S-1 was the same for both patient groups, 40 mg/m2 twice daily.
The primary endpoint of the SPIRITS study was overall survival (OS). Secondary endpoints included Response Rate, Time to Treatment Failure (TTF) and toxicity. The trial was designed to have 90% power to detect an improvement in median overall survival from 8 to 12 months.
S-1 is a novel oral fluoropyrimidine that combines 3 pharmacological agents: Tegafur, which is a pro-drug of 5 fluorouracil; gimeracil (5-chloro- 2,4 dihydropyridine, CDHP) which inhibits dihydropyrimidine dehydrogenase (DPD) enzyme; and oteracil (potassium oxonate, Oxo) a gastrointestinal side effects corrector.
S-1 is currently marketed in Japan for the treatment of gastric, colorectal, head and neck, non-small cell lung, metastatic breast and pancreas cancers. In the United States, Europe and other countries, the product is in phase III clinical development. Taiho commercializes and develops S-1 in Japan and in a few other countries of Asia. Sanofi- aventis collaborates on the current clinical development and is leading the future clinical development and commercialization of the product in the United States, Europe, and other countries in the world, except certain Asian countries.
About Gastric Cancer
Gastric (or stomach) cancer is the fourth most common type of cancer worldwide with more than 934,000 new patients every year. It is also the second most common cause of cancer death worldwide, with more than 700,000 deaths annually. There were about 22,800 new cases of gastric cancer in the United States in 2005. In Europe, this number is over 143,000 patients.
Taiho Pharmaceutical Co., Ltd (Taiho) is a company engaged in discovery, development, manufacturing and marketing of pharmaceutical products, with headquarters in Tokyo, Japan. Taiho is one of the leading companies focused on oncology. More information is available at the company's website at www.taiho.co.jp/english/index.html.
Sanofi-aventis is one of the world's leading pharmaceutical companies, 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 ).
Forward Looking Statements
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