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Preliminary Survival Data Announced From Completed Provenge Phase III Trial
The Provenge D9901 trial was designed to measure time to disease progression and time to development of disease-related pain in men with androgen independent prostate cancer. Patient survival was also measured. Preliminary analysis of survival data from this trial show a median survival of 26.3 months in the patients randomized to the Provenge treated group compared to 19.3 months in patients randomized to the placebo group who never received active therapy; a survival difference of 7 months. Seventy five percent of patients who were randomized to placebo and then had progression of their disease went on to receive active therapy in a crossover salvage protocol that accompanied the D9901 trial. The median survival in the patient population who received salvage Provenge was 23.9 months, a survival difference of 4.6 months compared to placebo.
Of the 127 men enrolled in the trial between January 2000 and October 2001, over half (67 men) are still alive, with more than 90 percent having received treatment with Provenge, either as initial treatment or as part of the salvage protocol. Final survival data from D9901 is anticipated to be available in late 2004 to early 2005.
"Androgen independent prostate cancer is a highly aggressive disease, with survival time normally in the range of 15 to 19 months and, while this trial was not designed, nor powered, to measure survival, a potential survival benefit of 7 months is substantial and meaningful for asymptomatic, metastatic androgen independent prostate cancer patients who have failed all treatment options and have no other form of available therapy," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. "We have previously reported that the results of D9901 indicated that Provenge delays disease progression and the onset of disease-related pain. Together these data provide evidence that Provenge holds promise to change the outlook for the many prostate cancer patients worldwide."
"We continue to be encouraged by the promise that Provenge holds for patients with advanced prostate cancer," said John Page, president of US TOO!, the world's largest prostate cancer support group. "Provenge may have the potential to dramatically change the way this disease is treated by offering a targeted therapy that can improve the quality of life for men in dire need of better treatment options."
In addition, the company has received the final audited results from the D9901 trial, which confirm the previously reported preliminary results. Comparison of the Provenge treated group to placebo group using the Kaplan-Meier method revealed a clinical benefit, as measured by a delay in time to disease progression, in the Provenge treated group (p = 0.061) that closely approached, but did not achieve, the pre-specified endpoint of the study (p = 0.05). The p value previously reported in the preliminary analysis was (p = 0.085).
Final audited results from the trial also confirmed the significant clinical benefit of delay in time to disease progression from Provenge treatment for men with androgen independent prostate cancer with a Gleason score of 7 or less (p = 0.001), an improvement from that previously reported in the preliminary analysis (p = 0.002). In addition, for these men, the probability of remaining free of cancer-related pain while on the study was more than two times higher (p = 0.016), preliminarily reported as (p = 0.019), than for patients treated with placebo. Treatment was generally well tolerated, with mild infusion-related fevers and chills the most common adverse events.
Provenge is currently in a pivotal double blind placebo-controlled Phase 3 trial, D9902B, seeking to confirm previous results that indicate the product may delay progression of disease and the development of disease-related pain. Dendreon has received a Fast Track designation for Provenge from the FDA in addition to a positive assessment under the Special Protocol Assessment (SPA) provision indicating that D9902B may serve as the basis for a Biologics License Application for Provenge.
To be eligible for the current Provenge D9902B study, patients must have metastatic prostate cancer that has progressed following hormone therapy and have a Gleason score of 7 or less. Patients must also be free of cancer-related pain. Information on Dendreon's clinical trials is available at www.dendreon.com.
Provenge is designed to stimulate a man's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).
About Prostate Cancer
Prostate cancer is the leading cancer diagnosed among men in the United States. More than one million men in the United States have prostate cancer, with 189,000 cases diagnosed and 30,200 deaths in 2002. There is currently no available therapeutic treatment for asymptomatic metastatic androgen independent prostate cancer.
About Gleason Score
The Gleason score is the most commonly used prostate cancer scoring system and is considered one of the most important prognostic indicators for prostate cancer. The score is based on tissue findings throughout the prostate that correlate with the aggressiveness of a tumor. High Gleason scores are indicative of aggressive cancers and are not associated with a favorable prognosis. In the androgen independent patient population approximately 75 percent of the patients have a Gleason score of 7 or less.
Source: Dendreon Corporation