Phase 1 Study Of Lapuleucel-T In Advanced Breast Cancer Patients Is Promising

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Dendreon Corporation published results from a Phase 1 study f NEUVENGE, an investigational active cellular immunotherapy for breast cancer patients.

The article highlights he safety profile, immune response and clinical activity of NEUVENGE in women with HER2/neu-positive breast cancer who have failed standard herapy.

"In addition to demonstrating that NEUVENGE was safe and well olerated, the T-cell responses seen in these patients and the prolonged isease stabilization in the absence of other anti-cancer therapies in many atients is promising," said John W. Park, M.D., associate clinical rofessor of medicine and neurosurgery at the University of California, San rancisco and lead author of the publication. "These observations are ncouraging and are suggestive of the clinical benefit of NEUVENGE, articularly in light of the aggressive cancer seen in these patients who ad progressed while on standard therapy. The findings warrant additional tudies of NEUVENGE for the many women with advanced breast cancer who have xhausted many of their treatment options."

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The Phase 1 study (D2000-2) was conducted to evaluate the safety and immunologic activity of NEUVENGE in patients with HER2-overexpressing metastatic breast cancer who had failed standard therapy, including prior treatment with chemotherapy and trastuzumab. All patients had experienced disease progression while on standard therapy. There were 19 patients enrolled in the study with 18 patients receiving treatment with NEUVENGE. Patients underwent three infusions of NEUVENGE at Weeks 0, 2, and 4 following randomization. Patients who achieved a partial response, or had stable disease lasting through Week 52, were eligible for re-treatment, a booster, using the same protocol and dose as the initial treatment. Endpoints included safety, immunologic activity and antitumor activity.

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 (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. NEUVENGE is designed to stimulate cellular immune responses against HER2/neu. HER2/neu is over-expressed in a variety of solid tumors, including breast, colorectal and ovarian cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

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