Dendreon announced publication of results from a Phase 1 study of Neuvenge, an investigational active cellular immunotherapy, in the Journal of Clinical Oncology.
The article highlights the safety profile, immune response and clinical activity of Neuvenge in women with HER2/neu-positive breast cancer who have failed standard therapy.

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 ( Herceptin ).
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.
Neuvenge ( Lapuleucel-T ) is an investigational product in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient's own immune system.
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.

Source: Dendreon, 2007

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