Date: 2015-02-25
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 2015 Genitourinary Cancers Symposium (ASCO GU) February 26-28 in Orlando, Florida
Company: Valeant Pharmaceuticals
Product: Provenge® (sipuleucel-T)
Action
mechanism: cell immunotherapy. Provenge® is a cellular immunotherapy designed to induce an immune response against prostate cancer cells. Provenge® uses immune cells which are extracted from the patient’s body. These cells are then mixed outside the patient’s body with a ‘fusion protein’, which is taken up by the cells. The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor (GM-CSF), a molecule that activates immune cells. When the immune cells are infused back into the patient, they stimulate an immune response against PAP, resulting in the immune system attacking and killing prostate cancer cells because they contain PAP. Provenge® is approved in the U.S. and the European Union as a treatment for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.
Disease: biochemically-recurrent prostate cancer (BRPC)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On February 25, 2015, Valeant Pharmaceuticals International announced the presentation of new long-term, preliminary results from the Phase II STAND trial demonstrating a robust immune response with Provenge® (sipuleucel-T) that continues two years after completing treatment in men with biochemically-recurrent prostate cancer (BRPC). The findings, along with valuable data from the ongoing Phase IV registry, PROCEED, related to increasing enrollment of African Americans in prostate cancer trials, are being presented at the 2015 Genitourinary Cancers Symposium (ASCO GU) February 26-28 in Orlando, Florida. The STAND study is a randomized, Phase II trial that consisted of two patient study groups. One group completed Provenge® two weeks before initiation of androgen deprivation therapy (ADT) and the second received Provenge® three months after the start of ADT. Provenge® is not indicated for use in patients with BRPC. 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. In 2012, an exploratory analysis of African American patients from the Provenge® Phase III trials suggested a positive treatment effect in this population. Building on this observation, another abstract being presented at ASCO GU highlights successful efforts that nearly doubled enrollment of African American men in the ongoing PROCEED registry. Through tactics such as utilizing research sites in racially and ethnically diverse communities, conducting focus groups with African Americans for insight on recruitment materials and study plans, and educating research staff on enrollment goals, enrollment in this population was 11.7 percent, a rate comparable to the U.S. African American population, versus 5.8 percent in the Provenge® Phase III registration trials. Overall, African American men are underrepresented in randomized clinical trials for prostate cancer, yet they have the highest incidence rate for prostate cancer in the United States and are more than twice as likely as white men to die of the disease.
