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"In addition to demonstrating that NEUVENGE was safe and well tolerated,the T-cell responses seen in these patients and the prolonged diseasestabilization in the absence of other anti-cancer therapies in many patientsis promising," said John W. Park, M.D., associate clinical professor ofmedicine and neurosurgery at the University of California, San Francisco andlead author of the publication. "These observations are encouraging and aresuggestive of the clinical benefit of NEUVENGE, particularly in light of theaggressive cancer seen in these patients who had progressed while on standardtherapy. The findings warrant additional studies of NEUVENGE for the manywomen with advanced breast cancer who have exhausted many of their treatmentoptions."
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Study Design
The Phase 1 study (D2000-2) was conducted to evaluate the safety andimmunologic activity of NEUVENGE in patients with HER2-overexpressingmetastatic breast cancer who had failed standard therapy, including priortreatment with chemotherapy and trastuzumab. All patients had experienceddisease progression while on standard therapy. There were 19 patientsenrolled in the study with 18 patients receiving treatment with NEUVENGE.Patients underwent three infusions of NEUVENGE at Weeks 0, 2, and 4 followingrandomization. Patients who achieved a partial response, or had stabledisease lasting through Week 52, were eligible for re-treatment, a booster,using the same protocol and dose as the initial treatment. Endpoints includedsafety, immunologic activity and antitumor activity.
Study Results
Treatment with NEUVENGE was generally well tolerated. The majority ofside effects were mild, including infusion-related fever and chills that wereusually of low grade and typically lasted for one to two days followinginfusion. No patient discontinued the trial because of toxicity.
Treatment with NEUVENGE stimulated significant immune responses, whichwere shown to be enhanced following booster infusions. Twenty-two percent ofpatients had evidence of anti-cancer activity. This included one patient whoexperienced a partial response lasting approximately 6 months and threepatients who had stable disease for over a year (74.9-94.0 weeks) without theaddition of any other cancer therapy other than the continuation ofbisphonates. Two additional patients had stable disease for up to 20 weeks.The study concluded that NEUVENGE was feasible, well-tolerated and showedevidence of anti-cancer activity.
"We are pleased that the results from this Phase I study of NEUVENGEdemonstrate 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 ofProvenge(R) (sipuleucel-T) in prostate cancer, further substantiate thepromise of active cellular immunotherapies as new treatments for differenttypes of cancer."
About NEUVENGE
NEUVENGE (lapuleucel-T) is an investigational product in a new class ofactive cellular immunotherapies (ACIs) that are uniquely designed to stimulatea patient's own immune system. ACIs hold promise because they may providepatients with a meaningful clinical benefit with low toxicities. NEUVENGE isdesigned to stimulate cellular immune responses against HER2/neu. HER2/neu isover-expressed in a variety of solid tumors, including breast, colorectal andovarian cancer. In clinical studies, patients typically received thre
