Dendreon’s Provenge sets record survival benefit

In January, Provenge failed to achieve its primary endpoint in another phase III trial, sending Dendreon’s shares down by close to 27%. In the recent trial, however, the investigational immunotherapy showed a significant survival benefit in men with asymptomatic, metastatic androgen-independent prostate cancer, when compared to patients receiving placebo.

According to the final three-year intent-to-treat analysis of Dendreon’s first randomized phase III clinical study, known as Study D9901, patients receiving Provenge had a 4.5 month improvement in their median survival and a greater than three-fold increase in survival at 36 months compared to patients receiving placebo. The 4.5-month median survival benefit is the longest ever reported from a phase III study in advanced prostate cancer.

Patients receiving Provenge had a median survival of 25.9 months compared to 21.4 months for patients in the placebo arm, a hazard ratio that implies that patients receiving placebo had a relative risk of dying 70% higher than those receiving Provenge.

Provenge was also well tolerated, with the most common adverse events reported being fever and chills lasting for one to two days.

“The survival benefit seen with Provenge is the largest ever reported in this patient population with any therapy,” said Dr Eric Small, professor of medicine and urology at the University of California, San Francisco. “This survival benefit, combined with a favorable safety profile, has the potential to provide an important new treatment option for prostate cancer patients.”