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news.Sanofi-aventis and its subsidiary BiPar Sciences have reported that a Phase III trial evaluating iniparib (BSI-201) in patients with metastatic triple-negative breast cancer (mTNBC) did not meet co-primary endpoints of overall survival and progression-free survival.
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The results of a pre-specified analysis in patients treated in the second- and third-line setting showed an improvement in overall survival and progression-free survival.
The overall safety analysis demonstrates that the inclusion of iniparib did not significantly add to the toxicity profile of gemcitabine and carboplatin.
The randomised Phase III trial enrolled 519 women with mTNBC from 109 sites in the US, who were randomised to receive a standard chemotherapy regimen (gemcitabine and carboplatin) with or without iniparib.
Sanofi-aventis Oncology senior vice president and head Debasish Roychowdhury said the trial did not meet its primary goal, the improvement in overall survival and progression-free survival in patients in the second- and third-line setting are important findings.