February 13, 2013--Dendreon Corporation (NASDAQ: DNDN) today announced that results from several ongoing or completed studies investigating the utility of PROVENGE ® (sipuleucel-T) in the treatment of advanced prostate cancer, including studies that may lead to new treatment approaches, as well as the investigational immunotherapy DN24-02 in patients with surgically-resected urothelial cancer, will be presented at the 2013 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in Orlando, Florida, from February 14-16, 2013.
“This year’s ASCO GU meeting is important for Dendreon because of the wide range of studies being presented that help us better understand PROVENGE,” said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer at Dendreon. “The studies that inform us about the potential use of PROVENGE in combination or sequenced with other advanced prostate cancer treatments are encouraging, and we look forward to additional data from these studies.”
Data presented include and can be accessed via the following links:
- Abstract #34: Randomized Phase II Trial Evaluating the Optimal Sequencing of Sipuleucel-T and Androgen Deprivation Therapy (ADT) in Patients with Biochemically-Recurrent Prostate Cancer (BRPC): A Phase II sequencing study evaluating PROVENGE followed by ADT or ADT followed by PROVENGE in men with biochemically-recurrent prostate cancer showed a prime-boost immune response effect based on antigen presenting cell activation patterns, and an analysis of serum samples indicated that there were no differences between the arms in cellular or humoral immune responses. Adverse events for each treatment were consistent with what was seen in pivotal trials.
- Abstract #114: A Randomized Phase II, Open-Label Study of Sipuleucel-T with Concurrent or Sequential Abiraterone Acetate (AA) in Metastatic Castrate-Resistant Prostate Cancer (mCRPC): A Phase II study evaluating concurrent or sequential therapy with AA plus prednisone (P) in men with metastatic castrate resistant prostate cancer demonstrated no significant differences in median cumulative CD54 upregulation (31.6 vs. 36.6), or the measure of antigen presenting cell activation, and CD54+ count (1.9 vs. 2.1x10 9) between the two arms, suggesting that PROVENGE can be manufactured during treatment with AA + P therapy. Adverse events for each treatment were consistent with what was seen in pivotal trials.
- Abstract #74: Sipuleucel-T Appears to Delay Time to First Use of Opioid Analgesics (TFOA) in Patients with Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate Cancer (mCRPC) on the IMPACT Trial: A retrospective analysis of a subset of the IMPACT trial demonstrated that relative to placebo, treatment with PROVENGE appeared to delay the first use of opioid analgesics for pain associated with advanced prostate cancer. Opioid therapy is currently recommended by the World Health Organization (WHO) for moderate to severe pain associated with cancer. In patients with advanced cancer, pain is described as moderate to severe in approximately 40-50 percent and very severe or excruciating in 25-30 percent of cases. 1
- Abstract #292: HER2 Expression in Patients with Surgically Resected Urothelial Cancer at High Risk of Recurrence Screened for the Phase II Randomized, Open-Label Trial of DN24-02, an Autologous Cellular Immunotherapy Targeting HER2: In the NeuACT study, Dendreon’s investigational DN24-02 is being studied in urothelial carcinoma. Preliminary data presented show a high frequency (>80 percent) of HER2 expression score of >1+ found in primary tumor and lymph node samples of patients with high-risk urothelial carcinoma, as is consistent with previously published data.
“These preliminary PROVENGE data are promising for the treatment of metastatic castrate resistant prostate cancer," said Eric Small, M.D., Chief of the Division of Hematology and Oncology, and Deputy Director, UCSF Helen Diller Family Comprehensive Cancer Center. “The medical community is particularly excited about the studies investigating the potential for treatment with PROVENGE and other currently approved treatments for advanced prostate cancer, which may provide us with new therapeutic approaches to help men fight this disease in the future.”