Phase 3 study of iniparib for the treatment of metastatic triple-negative breast cancer (mTNBC)

Sanofi-aventis announced that a randomized Phase 3 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. The study enrolled 519 women with mTNBC from 109 sites in the United States. Patients were randomized to receive a standard chemotherapy regimen (gemcitabine and carboplatin) with or without iniparib. Patients in the study had received up to two previous lines of chemotherapy in a metastatic setting. While the study failed to meet its pre-specified criteria for significance for co-primary endpoints, 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 2 study. The overall safety analysis indicates that the addition of iniparib did not significantly add to the toxicity profile of gemcitabine and carboplatin.

Iniparib (BSI-201) is a novel investigational anti-tumor agent with poly (ADP-ribose) polymerase (PARP) inhibitory activity in preclinical models.

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