Phase 2 study of iniparib (BSI-201) for the treatment of metastatic breast cancer

Sanofi-aventis and its subsidiary, BiPar Sciences, announced data from their Phase 2 study for iniparib (BSI-201) when co-administered with gemcitabine/carboplatin for the treatment of women with metastatic triple negative breast cancer (mTNBC). 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 6 months. Secondary endpoints included overall response rate and progression-free survival. Patients received gemcitabine/carboplatin alone (chemotherapy group) or in combination with iniparib until disease progression or unacceptable toxicity.

Fifty six percent of patients in the iniparib group showed a clinical benefit – defined as a complete or partial response or stable disease of at least 6 months – compared with 34% (P=0.01) of patients in the chemotherapy group alone. Median progression-free survival in the iniparib group was 5.9 months compared with 3.6 months in the chemotherapy group (95% CI (0.39-0.90) HR=0.59, P=0.01). The overall response rate was 52% in the iniparib group versus 32% (P=0.02) in the chemotherapy group alone. Although it was not a pre-specified endpoint of the trial, median overall survival among women who received iniparib (BSI-201) was 12.3 months, compared with 7.7 months among women who received chemotherapy alone – translating to a 43 percent reduction in the risk of death (95% CI, (0.36-0.90) HR=0.57, P=0.01).

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

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