The study of 98 men with metastatic prostate cancer showed a 20% improvement in median survival for patients who were randomized to receive Provenge compared to placebo.
In addition, at the three-year final follow up, the percentage of patients alive in the Provenge treated group was substantially greater than the percentage of patients alive who received placebo, however the results from this study did not meet the criteria for statistical significance based on a log rank test.
As in previous studies, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.
“We believe the data from this second study support what we saw in the first phase III trial – that Provenge prolongs survival in men with advanced prostate cancer,” said Dr Mitchell Gold, Dendreon’s president and CEO. “We plan to share all of the data collected to date from our clinical studies of Provenge with the FDA to determine the most efficient pathway for bringing Provenge to market.”
Prostate cancer is the most commonly diagnosed non-skin cancer in the US and the third most common cancer worldwide.