Iniparib Phase III study in metastatic triple-negative breast cancer does not meet primary goal

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its subsidiary, BiPar Sciences, today announced that a randomized Phase III trial evaluating iniparib (BSI-201) 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.

"While this trial did not meet its primary goal, we believe that the improvement in overall survival and progression-free survival in patients in the second- and third-line setting are important findings," said Dr. Debasish Roychowdhury, Senior Vice President and Head of sanofi-aventis Oncology. "We are conducting in-depth analysis to gain further insight into these Phase III results. Sanofi-aventis remains committed to improving outcomes for patients with triple-negative breast cancer where there is high unmet medical need."

Sanofi-aventis plans to discuss these data with United States and European health authorities in the near future. Full study results will be presented at an upcoming major oncology conference.  Patients with questions are encouraged to consult with their treating physicians, or call 1-800-633-1610. The current clinical development program for iniparib (BSI-201) continues in breast, lung and other cancers.