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news.Sanofi Aventis's wholly-owned subsidiary, BiPar Sciences has declared expected results from a randomized phase II 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).
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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 by tumors lacking expression of estrogen and progesterone receptors and without overexpression of HER2, were randomly assigned to receive GC in combination with BSI-201 or GC alone.
Approximately 62% of patients receiving BSI-201 in combination with GC showed clinical benefit, compared with 21% in the group receiving chemotherapy alone. Tumor response was observed in 48% of patients who received BSI-201 combined with chemotherapy, whereas patients receiving chemotherapy alone showed a response rate of 16%.
Barry Sherman, Executive Vice President of Development at BiPar, said: “These results represent an important development for a disease that currently has no approved standard of treatment.”
“Further study of BSI-201 will help us determine its full therapeutic potential in triple- negative breast cancer, as well as in other cancers, he added.