Data on Sanofi Cancer Candidate

Sanofi-Aventis (SNY - Analyst Report) and its wholly-owned subsidiary, BiPar Sciences, recently announced the publication of final phase II data on breast cancer candidate, iniparib (BSI-201), in The New England Journal of Medicine (NEJM).

Results from the phase II study, which was conducted with 123 patients diagnosed with metastatic triple negative breast cancer (mTNBC), showed that iniparib achieved significant clinical benefit when given in combination with Eli Lilly’s (LLY - Analyst Report) Gemzar (gemcitabine) / carboplatin. Patients were randomized to receive Gemzar/carboplatin alone (chemotherapy group) or in combination with iniparib.

Results showed that 56% of patients in the Gemzar/iniparib arm showed a clinical benefit compared with 34% in the chemotherapy arm alone. Median progression-free survival in the iniparib group was 5.9 months compared with 3.6 months in the chemotherapy group.

Meanwhile, the overall response rate was 52% in the iniparib group compared with 32% in the chemotherapy group alone. Median overall survival in women who received iniparib was 12.3 months, compared with 7.7 months in women receiving chemotherapy alone. This means that there was a 43% reduction in the risk of death in patients receiving iniparib.

Iniparib is currently in phase III studies for the metastatic triple negative breast cancer indication. Sanofi-Aventis intends to seek approval for the candidate in the US in the first quarter of 2011. The EU regulatory submission is scheduled to take place in the second quarter of 2011. Sanofi-Aventis reported that iniparib enjoys fast track status in the US.

Besides evalauting iniparib for metastatic triple negative breast cancer, Sanofi-Aventis is also conducting phase III trials with the candidate for squamous non-small cell lung cancer. The candidate is also in phase II trials for ovarian, uterine and brain cancers.

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