Sanofi-aventis Reports Top-line Results from Phase III Study with Iniparib

Sanofi-aventis SNY and its subsidiary, BiPar Sciences, today announced that a randomized Phase III trial evaluating iniparib in patients with metastatic triple-negative breast cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression-free survival. Importantly, the results of a pre-specified analysis in patients treated in the second- and third-line setting demonstrate an improvement in overall survival and progression-free survival, consistent with what was seen in the Phase II study. The overall safety analysis indicates that the addition of iniparib (BSI-201) did not significantly add to the toxicity profile of gemcitabine and carboplatin.