Barvarian Nordic (BN) released some outstanding news a few days ago. According to BN they hope to complete the enrollment in their phase 3, double blind, randomized, placebo controlled, international clinical trial of their cancer vaccine, Prostvac VF. The trial known as PROSPECT is scheduled to be completed with in the next 12 months, unless it is halted earlier.
Their announcement in the way of a media release confirms that BN has reached an agreement with the U.S. Food & Drug Administration (FDA) regarding a planned interim analyses of the data. This agreement would allow BN to stop the trial early if there is clear evidence of superior efficacy in one of the three arms of the trial.
Prostvac VF, like sipuleucel-T (Provenge), is an immunotherapeutic vaccine. Provenge has already been approved by the FDA is being used in the clinic, but Prostvac VF is still in trial. They both are designed to fill the same market segment, men with metastatic, castration-resistant, chemotherapy-naive prostate cancer. However, Prostvac VF is an “off-the-shelf” form of immunotherapeutic agent that does not require each dose to be individually created for each man as Provenge requires. If approved by the FDA, Prostvac could supplant Provenge as the go to treatment because of its ease of use, however I wonder what could happen if these two treatments are used in conjunction with each other.
Additional information about this trial is available at the Clinical Trials.gov web site. Additional information about the treatment can be seen on this blog by searching for Prostvac in the search box.
Joel T Nowak, M.A., M.S.W.
PROSPECT Trial started Nov. 2011.
Estimated primary compkletion date Dec. 2014
Does this mean that BNIT has possibly released to the media
preliminary information on outcomes or has reported to FDA regarding a planned interim analysis of the available data?
Professor Stroeven – It is my understanding that there was a preliminary analysis just before the summer. There wasn’t any data shared publicly, but the trial has continued post analysis. – Joel