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news.Dendreon has announced the presentation of preliminary data from a long-term analysis of the Phase II STAND study demonstrating that tumor-specific T-cell responses appear to be enhanced and sustained when Provenge (sipuleucel-T) is given after androgen deprivation therapy (ADT) in patients with biochemically-recurrent prostate cancer (BRPC) at high risk for metastases.
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These data will be presented at the 29th Annual European Association of Urology (EAU) Congress taking place from 11 April to 15 April 2014 in Stockholm, Sweden.
Dendreon executive vice president and chief medical officer Dr Andrew S. Sandler noted the company is pleased with the preliminary STAND data, which show the continued potential for sequencing PROVENGE with other treatments and the impact that immunotherapy has on immune responses in advanced prostate cancer patients.
"The presentation of these data at EAU highlights Dendreon’s commitment to expanding awareness and understanding of immunotherapy and PROVENGE in Europe as we prepare to make PROVENGE available to advanced prostate cancer patients beyond the United States," Dr Sandler added.
ADT is a standard treatment option for men with BRPC after failure of local therapy. The STAND study is a randomized, Phase II trial that consisted of two patient study groups, one completing PROVENGE two weeks before ADT and the second receiving PROVENGE three months after the start of ADT.
Preliminary results suggest enhanced cellular immune responses when PROVENGE was given after ADT, and these responses were persistent for at least 12 months and robust in both patient groups.
PROVENGE is approved in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Dendreon plans to make PROVENGE commercially available in Europe, beginning with Germany and the United Kingdom, through Centers of Excellence.
PROVENGE is intended solely for autologous use and should under no circumstances be administered to other patients.
The safety evaluation of PROVENGE was based on data from 601 prostate cancer patients in four randomized clinical trials and post-marketing surveillance.
PROVENGE should be delayed in patients with active systemic infection until resolution and used with caution in patients with a history of embolic and thrombotic events, including cerebrovascular disease and cardiovascular disorders.
Serious adverse reactions reported include acute infusion reactions (occurring within one day of infusion), catheter sepsis, staphylococcal bacteremia, myocardial infarction and cerebrovascular events.
The most commonly reported adverse reactions were chills, fatigue, pyrexia (fever), nausea, arthralgia (joint ache), headache, and vomiting.