Iniparib: Additional Phase III data

Additional data from an open-label, U.S. Phase III trial in 519 women with metastatic triple-negative breast cancer showed that IV BSI-201 plus gemcitabine and carboplatin led to median OS and PFS, the co-primary endpoints, of 11.8 and 5.1 months, respectively, vs. 11.1 and 4.1 months for gemcitabine and carboplatin alone (p=0.284 and p=0.027, respectively). Sanofi said the study did not meet the pre-specified criteria for significance on the co-primary endpoints, but would not disclose the criteria. The most common >=grade 3/4 adverse events were neutropenia, anemia, thrombocytopenia and leukopenia. Patients received gemcitabine 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. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...