An independent data monitoring committee (IDMC) has reported a 20% reduction in the risk of death in prostate cancer patients treated with Provenge compared with those given a placebo.
Provenge (sipuleucel-T), an investigational active cellular immunotherapy, was the subject of a phase III randomised clinical trial designed to assess its safety and efficacy.
The drug’s maker, Dendreon, remains blinded to the resulting data, but the IDMC has confirmed that patients given Provenge face a lower risk of death. The IDMC did not identify any safety concerns and recommended that the study continue to its final analysis.
Dendreon’s chief executive, Mitchell Gold, commented: “The treatment effect we have observed in this interim analysis is consistent with that observed in the integrated analysis of our previous phase III trials in this patient population when analysed at a similar 24-month follow-up time.
“Given the delayed treatment effect we have seen in previous studies, we are pleased to see evidence suggesting a prolongation of survival in the Provenge arm at the time of the interim analysis, as well as a favourable safety profile.”
The company said that if the study demonstrates a 22% reduction in the risk of death by the final analysis, due in the middle of 2009, it should meet its primary endpoint of overall survival.
Copyright PA Business 2008