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news.Dendreon has presented positive data demonstrating the correlation of a measure of the cumulative potency of Provenge, an investigational active cellular immunotherapy for hormone-refractory prostate cancer, with overall survival.
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Dendreon’s researchers evaluated cumulative product release parameters of Provenge, including CD54 upregulation (a measure of product potency defined as the increase of CD54 molecules expressed on Antigen Presenting Cells [APC] after incubation with the Provenge Antigen Delivery Cassette) and the number of total nucleated cells (TNCs) among patients treated with Provenge or sipuleucel-T (n=146).
These Phase III results showed that Provenge patients experienced improved survival if they received more cells across the three doses of Provenge (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients’s baseline prognostic factors. However, the CD54 upregulation ratio appeared to be an independent predictor of survival in patients who received Provenge, as the correlation remained strong even after adjusting for baseline prognostic factors (p=0.022).