Sanofi-Aventis and its BiPar Sciences subsidiary have reported that iniparib (BSI-201) has not met the co-primary endpoints of overall survival and progression-free survival in a Phase III trial evaluating the drug in patients with metastatic triple-negative breast cancer (mTNBC).
The overall safety analysis demonstrated that the inclusion of iniparib did not significantly add to the toxicity profile of gemcitabine and carboplatin.
However, the results of a pre-specified analysis in patients treated in the second and third-line settings showed an improvement in overall survival and progression-free survival.
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 Dr Debasish Roychowdhury said that although the trial did not meet its primary goal, the company believes that the improvements in patients in the second and third-line settings are important findings.