* Provenge improved 3-year survival by 38 percent
* Provenge patients lived 4.1 months longer on average
* No major adverse events seen with Provenge in study
NEW YORK, April 28 (Reuters) – An experimental cancer vaccine developed by Dendreon Corp (DNDN) improved three-year survival of patients with advanced prostate cancer by 38 percent compared with a placebo, according to data from a closely watched study unveiled on Tuesday.
Patients in the 512-subject study who received Dendreon’s Provenge lived an average of 4.1 months longer than those who received a placebo — 25.8 months versus 21.7 months — in the late-stage clinical trial, researchers said.
“This is a game changer in my business,” said Dr David Penson, associate professor of urology at the University of Southern California, who presented the data at the American Urological Association meeting in Chicago.
“I have no doubt that if this drug becomes commercially available in the United States, it will replace chemotherapy” in this patient population, Penson said in a telephone interview.
The results further bolster the likelihood that Provenge will become the first approved therapeutic vaccine for any type of cancer. Dendreon plans to seek U.S. approval of Provenge, known chemically as sipuleucel-T, in the fourth quarter.
Penson called the data convincing and forecast that “it will reinvigorate cancer vaccine therapy” — a field that had previously been littered with failures.
Earlier this month Dendreon said Provenge achieved the main goal of this study, which was reducing the overall risk of death by at least 22 percent compared with a placebo — an announcement that more than doubled the price of the company’s heavily-shorted shares.
Details of the study, which showed the vaccine reduced risk of death by a statistically significant 22.5 percent, were not made public until the presentation at the urology meeting.
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