Treatment with NEUVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion. No patient discontinued the trial because of toxicity.
Treatment with NEUVENGE stimulated significant immune responses, which were shown to be enhanced following booster infusions. Twenty-two percent of patients had evidence of anti-cancer activity. This included one patient who experienced a partial response lasting approximately 6 months and three patients who had stable disease for over a year (74.9-94.0 weeks) without the addition of any other cancer therapy other than the continuation of bisphonates. Two additional patients had stable disease for up to 20 weeks. The study concluded that NEUVENGE was feasible, well-tolerated and showed evidence of anti-cancer activity.
"We are pleased that the results from this Phase I study of NEUVENGE demonstrate its potential as a treatment for advanced breast cancer patients," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "These data, together with the data we have published on the use of Provenge(R) (sipuleucel-T) in prostate cancer, further substantiate the promise of active cellular immunotherapies as new treatments for different types of cancer."
NEUVENGE (lapuleucel-T) is an investigational product in a new class of
active cellular immunotherapies (ACIs) that are uniquely designed to
stimulate a patient's own immune system. ACIs hold promise because they may
provide patients with a meaningful clinical benefit with low toxicities.
|SOURCE Dendreon Corporation|
Copyright©2007 PR Newswire.