Date: 2011-01-27
Type of information:
phase: 3
Announcement: results
Company: Sanofi-Aventis (France)
Product: BSI-201 (iniparib)
Action mechanism: anti-tumor agent with poly (ADP-ribose) polymerase (PARP) inhibitoryactivity
Disease: metastatic triple-negative breast cancer
Therapeutic area: CancerOncology
Country:
Trial details: The BSI-201 Phase III 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) on days one and eight of each 21- day cycle, with or without BSI-201 5.6 mg/kg, which was administered on days one, four, eight and 11 of each 21-day cycle. Patients in the study had received up to two previous lines of chemotherapy in a metastatic setting. The co-primary endpoints were overall survival and progression-free survival.
Latest
news: This randomized Phase III trial evaluating BSI-201 (iniparib) 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 BSI-201 did not significantly add to the toxicity profile of gemcitabine and carboplatin.
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.
The current clinical development program for BSI-201 continues in breast, lung and other cancers.
