Dendreon Corporation DNDN today 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. These data will be presented at the
29^th Annual European Association of Urology (EAU) Congress taking place from
April 11-15, 2014 in Stockholm, Sweden.^1
“We are 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,”
said Andrew S. Sandler, M.D., executive vice president and chief medical
officer at Dendreon. “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.”
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.
“The STAND study results are encouraging as they provide additional evidence
on how sipuleucel-T can be sequenced with other treatments which will assist
clinician decision-making upon whether immune responses correlate with certain
clinical parameters, such as prostate specific antigen (PSA) recurrence,” said
Neal Shore, M.D., medical director at the Carolina Urologic Research Center.
PROVENGE is approved in all 28 countries of the European Union (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.
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