Updated Overall Survival Data from a Phase 3 Trial of Ipilimumab vs. Placebo in Men Post Chemotherapy Receiving Radiation Therapy – Still Needs Time

Presented in a poster at the recent European Society of Medical Oncologist (ESMO) there was a data update of the phase 3 clinical trial (CA184-043) which evaluated overall survival (OS) in men having radiotherapy (RT) followed by either the immunologic drug Ipilimumab (Ipi) or with a placebo. Initially, this trial did not meet its endpoint and was considered to have failed (Kwon ED, et al. Lancet Oncol 2014 in press). This update included an additional year of data. In the trial 799 men were randomized to receive a single dose of RT to their bone metastases followed by either Ipi [...]

A Real Role for Immunotherapy in the Treatment of Advanced Prostate Cancer

Immunotherapy has a major and expanding role in the treatment of cancer, including advanced prostate cancer. Over time there have been a number of naysayers as the immunotherapy Provenge has played the role whipping boy by critics. The common criticism leveled at Provenge can be summed up simply, “It doesn’t work.” The plain truth is that this criticism is not true. Provenge does extend life, but it does not affect a man’s PSA nor does it affect radiologic progression. However, it does extend life, the most important factor for us with advanced prostate cancer. Why is Provenge (and immunotherapy) not [...]

The Twists and Turns For Provenge

It was announced today that preliminary results from the Phase II STAND trial demonstrates continued and what is described as a robust immune response with Provenge (sipuleucel-T) that continues two years after completing treatment in men with biochemically-recurrent prostate cancer (BRPC). This finding, along with data from the ongoing Phase IV registry PROCEED trial, are being presented at the 2015 Genitourinary Cancers Symposium (ASCO GU) conference. The STAND study is a randomized, Phase II trial that consisted of two patient study groups designed to eventually allow the possible expansion of the FDA approval for Provenge to men who are still [...]

*Provenge to Survive Dendreon’s Bankruptcy – Welcome Valeant to the Prostate Cancer Community

Dendreon, the manufacture of the only FDA approved immunologic therapy for prostate cancer had been burdened with significant debt. The debt came from their R&D of Provenge, their seeking FDA approval and the construction of three manufacturing plants to produce the treatment. Sadly, the company was unable to get its income ahead of its debt burden and was forced to seek bankruptcy protection. Dendreon was put up for sale by public auction supervised by the U.S. Bankruptcy court. It was announced yesterday that the bidding process has been completed and another pharmaceutical company, Valeant will acquire the rights to Dendreon’s [...]

By | February 11th, 2015|Advanced Prostate Cancer, immunotherapy, Provenge, Uncategorized, vaccines|2 Comments