Sanofi-Aventis (SNY) and its subsidiary, BiPar Sciences, recently announced disappointing results from a phase III study that was being conducted with the company’s oncology candidate, iniparib (BSI-201).
The randomized phase III study was conducted with 519 women suffering from metastatic triple-negative breast cancer (mTNBC). Patients were randomized to undergo treatment with Eli Lilly’s (LLY) Gemzar (gemcitabine) plus carboplatin with or without iniparib.
Results showed that iniparib failed to prolong overall survival and progression-free survival in patients with metastatic triple-negative breast cancer (mTNBC). However, iniparib was found to improve overall survival and progression-free survival in the second- and third-line settings.
As far as safety is concerned, no significant increase in toxicity was observed with addition of iniparib to Gemzar and carboplatin. Full results will be presented at an upcoming oncology meeting.
The results were a disappointment as iniparib had fared well in a phase II study. Results from the phase II study, which was conducted with 123 patients diagnosed with mTNBC had showed that iniparib achieved significant clinical benefit when given in combination with Gemzar (gemcitabine) / carboplatin. Patients were randomized to receive Gemzar/carboplatin alone (chemotherapy group) or in combination with iniparib.
Sanofi-Aventis intends to discuss the phase III results with the US and EU regulatory authorities. The US and the EU filings for the candidate were earlier expected to take place in the first and second quarters of 2011, respectively.
Besides evaluating 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 breast, lung and other cancers.
