Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer
December 17, 2015
"The positive iniparib phase II data in this difficult to treat form of breast cancer is encouraging and underscores the innovative science and approach we have taken as we continue to investigate iniparib's potential to address this unmet medical need," said Atul Dhir M.D., CEO, BiPar Sciences, a wholly- owned subsidiary of sanofi-aventis.
Phase II Iniparib Study
This multicenter, open-label, randomized study included 123 women with mTNBC. The primary endpoints were safety and tolerability and clinical benefit rate of iniparib (BSI-201) defined as a complete or partial response or stable disease of at least six months. Secondary endpoints included overall response rate and progression-free survival. Overall survival also was assessed, although it was not a pre-specified endpoint of the trial. Patients received gemcitabine/carboplatin alone (chemotherapy group) or in combination with iniparib (BSI-201) until disease progression or unacceptable toxicity. Patients in the chemotherapy group whose disease progressed were allowed to cross over to the iniparib (BSI-201) plus chemotherapy group. Efficacy analyses were conducted on the intent-to-treat (ITT) population.