sipuleucel-T (APC8015)

01/01/2010 - "Sipuleucel-T is an antigen-presenting cell-based vaccine that recently demonstrated a significant 4.8-month improvement in overall survival in advanced prostate cancer patients and was well tolerated. "
07/01/2012 - "Sipuleucel-T is an effective treatment for prostate cancer, although its widespread use is uncertain for complex social and economic reasons."
08/15/2009 - "The safety and efficacy of sipuleucel-T was evaluated in 2 identically designed, randomized, double-blind, placebo-controlled trials (D9901 and D9902A) conducted in men with advanced prostate cancer. "
12/01/2015 - "Additional trials are aiming to expand the application of sipuleucel-T to prostate cancer patients beyond the mCRPC setting. "
11/01/2014 - "This prospective trial evaluated the direct immune effects of systemically administered sipuleucel-T on prostatic cancer tissue in the preoperative setting. "

01/01/2014 - "To prove clinical benefits of cancer vaccine is currently difficult, except for one phase III trial has documented improved overall survival with the vaccine, Sipuleucel-T, although induction of anti-tumor immune responses through cancer vaccine is theoretically promising and would be straightforward. "
02/22/2012 - "However, the lack of demonstrable tumor responses has prompted calls for scrutiny of the design of the trials in which sipuleucel-T demonstrated a 4-month survival benefit. "
06/15/2011 - "One of these trials led to the registration of sipuleucel-T, the first therapeutic vaccine to be approved for cancer patients. "
11/01/2015 - "Sipuleucel-T (Provenge®): Autopsy of an Innovative Change of Paradigm in Cancer Treatment."
10/01/2015 - "Despite a positive recommendation by the National Comprehensive Cancer Network, sipuleucel-T's complex administration, high price, and uncertainty about the reimbursement status deterred doctors from prescribing the product. "

11/01/2011 - "However, sipuleucel-T has not shown any improvement in affecting patients' time to disease progression."
01/01/2013 - "The objective of this study is to identify the incidence and possible predictors for disease progression in patients receiving sipuleucel-T. "
01/01/2013 - "In previous studies sipuleucel-T did not delay disease progression, but demonstrated an overall survival benefit compared to placebo. "
08/01/2011 - "Recent Phase III studies also demonstrated sipuleucel-T's efficacy in prolonging median survival in patients with CRPC, despite little or no effect on clinical disease progression or surrogates such as serum PSA kinetics. "
01/01/2008 - "In clinical trials, the primary endpoint of time to disease progression was not met; however, an underpowered analysis of data suggests that sipuleucel-T prolongs survival by a median of 4.5 months compared with placebo. "

05/01/2011 - "Sipuleucel-T, an autologous dendritic cell based vaccine extended survival in men with relatively asymptomatic metastatic CRPC without visceral metastasis. "
12/01/2015 - "Sipuleucel-T provides improved overall survival in asymptomatic patients and (223)radium provides improved overall survival in chemotherapy naïve and chemotherapy treated patients with symptomatic bone metastases. "
09/01/2014 - "Today, the picture is vastly different: several additional therapies have each demonstrated a survival benefit such that we now have chemotherapy (cabazitaxel), androgen suppressive agents (abiraterone acetate and enzalutamide), a cellular vaccine (sipuleucel-T) and radium-233 (for symptomatic bone metastases). "
12/01/2013 - "Other therapeutic targets that have established efficacy in randomized phase 3 trials include bone metastases (ie, radium 223 dichloride), the immune system (ie, sipuleucel-T), and tubulin (ie, cabazitaxel). "
08/01/2012 - "Over the last year, four Phase III therapeutic trials have met their primary endpoint of improved overall survival: sipuleucel-T in the pre-chemotherapy setting, cabazitaxel and abiraterone in the post-docetaxel setting, and radium-223 for those with symptomatic bone metastases who have received or are not suitable to receive docetaxel. "

01/01/2014 - "However, both sipuleucel-T vaccine and anti-CTLA-4 antibody have been approved by FDA for the treatment of metastatic prostate cancer and melanoma, respectively. "
05/01/2015 - "Randomized trials testing sipuleucel-T and prostvac-vf in prostate cancer and ipilimumab and eltrapuldencel-T in melanoma were associated with low objective response rates, no improvement in PFS, but statistically significant improvement in OS. "
01/01/2014 - "Ipilimumab is currently approved for the treatment of metastatic melanoma and sipuleucel-T is approved for advanced prostate cancer. "
08/01/2013 - "The first vaccine and the first immunomodulating agent were recently approved by the US Food and Drug Administration (FDA) for the treatment of prostate cancer (sipuleucel-T) and melanoma (ipilimumab), respectively. "
06/01/2012 - "As a result, two active immunotherapy agents, sipuleucel-T and ipilimumab, have been approved by the US FDA for the treatment of prostate cancer and melanoma, respectively. "