“These results confirm the clinical value of Provenge to prolong survival in patients with advanced prostate cancer,” said Dr. Philip Kantoff, head of the prostate cancer program and chief of the division of solid tumor oncology at the Dana-Farber Cancer Institute and Harvard Medical School, and a principal investigator of the Provenge study, in a statement.

“We’ve been waiting a long time for a drug that is well tolerated and that gives men with advanced prostate cancer another option,” said Christopher Amling, chief of urology at Oregon Health & Science University, Portland, Ore., who wasn’t involved with the study. This “has an apparent survival advantage that exceeds survival that we have seen with chemotherapy in advanced disease.” Quoted today in Wall Street Journal.

“The ability to boost survival for patients is the gold standard endpoint in prostate cancer clinical trials,” said Dr. Ira D. Sharlip, AUA spokesman. “The ability to give these patients both increased survival and, possibly, improved quality of life is very important.” Quoted today in Seattle Times.

Dr. George Hemstreet, chief of urology at University of Nebraska Medical Center who attended the meeting, called the results “a pretty significant breakthrough.”

“The fact that a vaccine would work in patients with large tumor burdens is really amazing,” Dr. Hemstreet said. “These are elderly patients, and they are very fragile, so anything that has minimal toxicity is an improvement.” Quoted in The New York Times.

In today’s final data from the 512-patient clinical trial called Impact, 31.7% of men who received the medicine were still alive after three years, compared with 23% who received placebo.

Provenge prolonged the lives of advanced prostate cancer patients by 4.1 months compared to placebo.

The reduction in risk of death for patients taking Provenge compared to placebo was 22.5%, just beating the threshold of a 22% reduction in the FDA agreement.

Probability that the results were due to chance (p-value) was 0.032, or 3.2%. That’s better than the target set by agreement with the FDA of p-value of 0.043.

Dendreon’s CEO and staff held a phone conference after Tuesday’s AUA presentation. This and the slides shown at AUA are archived online at dendreon.com. Our link should open a new window in your browser and your media player should let you click to play the audio. To view the slides, click on the numbers below the right hand panel.