Dendreon presents additional Provenge data

Dendreon Corp. (NASDAQ:DNDN) reported additional data from the Phase III IMPACT trial (D9902B) for Provenge sipuleucel-T to treat metastatic androgen-independent prostate cancer (AIPC). Provenge continued to extend median overall survival (OS) by 4.1 months compared with placebo after a median follow-up of 36.5 months (p=0.017). Provenge patients had a 36-month survival rate of 32.1% vs. 23% for placebo at 36.5 months. The double-blind, North American trial enrolled 512 men. Data were presented at the American Society of Clinical Oncology Genitourinary Symposium in San Francisco.

Dendreon previously reported that Provenge met the primary endpoint of significantly improving OS vs. placebo after a median follow-up of 34.1 months (25.8 vs. 21.7 months, p=0.032). A BLA for Provenge to treat metastatic castrate-resistant prostate cancer is under FDA review. The PDUFA date is May 1. Provenge is composed of autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine (See BioCentury, April 20, 2009). ...