publication date: Mar. 31, 2015

Provenge Immune Response Continued For Two Years in Phase II Study in BRPC


Preliminary results from the phase II STAND trial showed a robust immune response with Provenge (sipuleucel-T) that continued two years after completing treatment in men with biochemically-recurrent prostate cancer.

The STAND study is a randomized trial consisting of two patient study groups. One group completed Provenge two weeks before initiation of androgen deprivation therapy and the second received Provenge three months after the start of ADT.

Preliminary results from STAND indicate that immune responses were observed in both study arms and suggest there may be a greater cellular immune response in patients who received Provenge prior to ADT compared with those who received Provenge following three months of ADT. Humoral immune responses were observed and similar between both treatment arms.

The findings, along with data from the ongoing phase IV registry, PROCEED, related to increasing enrollment of African Americans in prostate cancer trials, were presented at the 2015 Genitourinary Cancers Symposium. The trial was sponsored by Valeant Pharmaceuticals International Inc.

“It is very encouraging to observe that PROVENGE provides an immune response in men with biochemical-recurrent prostate cancer long after the course of androgen deprivation therapy has ended,” said Neal Shore, medical director at the Carolina Urologic Research Center. “This study may also provide guidance on the optimal sequencing of immunotherapy and ADT in biochemical-recurrent prostate cancer.”

Provenge, a personalized immunotherapy, is approved in the U.S. and the European Union as a treatment for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.

In 2012, an exploratory analysis of African American patients from the Provenge phase III trials suggested a positive treatment effect in … Continue reading CCL March – Provenge Immune Response Continued For Two Years in Phase II Study in BRPC

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