Iniparib: Phase III data

An open-label, U.S. Phase III trial in 519 women with metastatic triple-negative breast cancer showed that BSI-201 plus Gemzar gemcitabine and carboplatin missed the co-primary endpoints of significantly improving OS and PFS vs. Gemzar and carboplatin alone. However, sanofi-aventis said a pre-specified analysis of patients treated in the second- and third-line setting with BSI-201 plus Gemzar and carboplatin showed an improvement in OS and PFS that was consistent with what was seen in a Phase II trial for the indication. Patients received Gemzar and carboplatin on days 1 and 8 of each 21-day cycle, with or without 5.6 mg/kg BSI-201 on days 1, 4, 8 and 11 of each cycle. ...