Sanofi-aventis and its subsidiary, BiPar Sciences, today announce Phase 3 trial for BSI-201 in combination with chemotherapy in patients with metastatic triple-negative breast cancer. BSI-201 is a targeted therapy that inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.
Results of the Phase 2 study were presented at the American Society of Clinical Oncology (ASCO) annual conference on May 31, 2009. The l trial involved 116 women with metastatic TNBC who were randomly assigned to receive GC in combination with the BSI-201 or GC alone.
• 62 percent of patients receiving BSI-201 in combination with GC showed clinical benefit,
• 21 percent in the group receiving chemotherapy alone benefitted.
• 48 percent of patients who received BSI-201 combined with chemotherapy had some level of tumor reduction.
* 16 percent of those receiving chemotherapy alone had tumor reductions.
• 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 for women who received chemotherapy alone. T
In the Phase 3 trials, 60-75 sites will be distributed throughout the United States. All patients will have the opportunity to receive BSI-201.
Read the news release here.