Abstract
4534 Background: Sipuleucel-T is an autologous cellular immunotherapy approved by the FDA for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Methods: After disease progression, subjects in the control arms of 3 randomized controlled trials (RCT) of sipuleucel-T were offered 3 infusions of APC8015F, an autologous immunotherapy made from cells cryopreserved at the time of control generation. Results: 165/249 (66.3%) of the control group received APC8015F. Median time from randomization to first APC8015F infusion was 5.2 months (range 1.8 to 33.1), and from objective disease progression to first infusion was 2.2 months (range 0.5 to 14.6). 145 subjects (87.9%) received all 3 infusions. APC8015F-treated subjects had improved post-progression survival relative to untreated controls (HR = 0.52 [95% CI: 0.37, 0.73]; unadjusted Cox regression; P = 0.0001, log rank test), with median survival times of 20.0 and 9.8 months, respectively. APC...
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