Dendreon Announces Results of Provenge Study in Early-Stage Prostate Cancer

Dendreon has announced results of an open-label Phase II study of Provenge (APC8015) as a monotherapy in men with rising PSA post definitive local therapy (androgen-dependent prostate cancer).

Provenge is the company's investigational immunotherapy for the treatment of prostate cancer. The study, referred to as D9905, suggests that Provenge as a single agent may lead to improved PSA doubling time (PSADT) in patients with early-stage prostate cancer. PSADT is the time it takes for the prostate-specific antigen (PSA) value to double. This measure is used to help predict the possibility of metastasis and time to death in early-stage prostate cancer.

The data from Study D9905 demonstrated that 71 percent (12 of 17) of evaluable patients had a prolongation in their PSADT post-treatment with Provenge. After treatment with Provenge, patients had a 52 percent increase in PSADT (5.2 months to 7.9 months). In addition, in five patients, the post-treatment PSADT was greater than 12 months, with one of these patients showing a 20-fold increase in post-treatment PSADT compared with pretreatment PSADT (66.6 months versus 3.5 months). As in previous studies, Provenge also was shown to be generally well-tolerated with the most common side effects being fever and chills typically of low grade and short duration.