Data from Phase 3 clinical trials of PROVENGE in advanced prostate cancer to be presented at ASCO 2010

May 21 2010

Dendreon Corporation (Nasdaq: DNDN) today announced the upcoming presentation of data from integrated analyses of three Phase 3 PROVENGE® (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in advanced prostate cancer, to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Monday, June 7 at 8:00 a.m. CT.

"With the recent FDA approval of PROVENGE for asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer, patients now have a new treatment option available that prolongs survival," said Daniel P. Petrylak, M.D., program director of the Genitourinary Oncology Section in the Division of Hematology/Oncology at Columbia University.  "Cancer immunotherapy represents an entirely new era in medicine and patient care."

The exploratory analyses include data from three Phase 3 trials in patients with metastatic castrate resistant prostate cancer (Studies D9901, D9902A, and IMPACT) that were integrated to examine the treatment effect in a larger group of patients, the use of docetaxel before and after randomization, and relationships between certain product parameters and clinical outcome.  These include:

• A poster presentation by Dr. Celestia Higano, professor of oncology and urology at the University of Washington, titled, "Predictors of outcome and subgroup results from the integrated analysis of sipuleucel-T trials in metastatic castration resistant prostate cancer (abstract #4550)."
• A poster presentation by Dr. Petrylak titled, "Immunotherapy survival effect persists independent of post-randomization docetaxel use in Phase 3 studies of sipuleucel-T (abstract #4551)."
• A poster presentation by Dr. Frances P. Stewart, senior biostatician at Dendreon, titled, "Correlation between product parameters and overall survival in 3 trials of sipuleucel-T, an autologous active cellular immunotherapy for the treatment of prostate cancer (abstract #4552)."

PROVENGE is the first autologous cellular immunotherapy to be approved by the U.S. Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE Safety

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence greater than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.