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Investigational Cancer Drug BSI-201 Showed Clinical Benefit in 62% of Patients with Triple-Negative Metastatic Breast Cancer and Significantly Prolonged Survival
Date:6/3/2009

PARIS and BRISBANE, California, June 3 /PRNewswire-FirstCall/ --

- Data Highlighted in Plenary Session of 2009 American Society of Clinical Oncology Annual Meeting

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its fully owned subsidiary, BiPar Sciences, today announced results from a randomized Phase 2 clinical trial of BSI-201, a poly ADP-ribose polymerase (PARP) inhibitor, in combination with gemcitabine and carboplatin (GC) chemotherapy, in patients with metastatic triple-negative breast cancer (TNBC). BSI-201 is a novel investigational agent that acts by inhibiting PARP1, an enzyme that repairs DNA damage.

In this study, 116 women with metastatic TNBC, defined as tumors lacking expression of estrogen and progesterone receptors and without overexpression of HER2, were randomly assigned to receive GC in combination with the investigational agent BSI-201 or GC alone. Patients assigned to receive chemotherapy without BSI-201 were allowed to receive BSI-201 at the time of disease progression.

The primary study endpoint was the rate of clinical benefit, defined as complete or partial response or stable disease of at least 6 months. Secondary study endpoints included progression-free survival, overall survival and safety.

Approximately 62 percent of patients receiving BSI-201 in combination with GC showed clinical benefit, compared with 21 percent in the group receiving chemotherapy alone (p= 0.0002). Tumor response (complete or partial response) was observed in 48 percent of patients who received BSI-201 combined with chemotherapy, whereas patients receiving chemotherapy alone showed a response rate of 16 percent. Women who received BSI-201 had a median progression-free survival of 6.9 months and overall survival of 9.2 months compared with 3.3 and 5.7 months, respective
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SOURCE Sanofi-aventis
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