Results from a Phase 1 study of NEUVENGE, Dendreon’s candidate vaccine for breast cancer, appeared today in Journal of Clinical Oncology. Testing of Neuvenge in clinical trials runs several years behind Provenge, which is in an ongoing Phase 3 trial. Out of 18 patients with advanced breast cancer who received Neuvenge, 1 patient showed partial response for 6 months and 3 patients had stable disease lasting more than a year.

Neuvenge antigen is made from “sequences from intracellular and extracellular domains of human epidermal growth factor receptor 2 (HER-2) linked to granulocyte-macrophage colony-stimulating factor.”

Results: Nineteen patients were enrolled; 18 patients received treatment. Therapy was well tolerated, with no grade 3 or 4 adverse events associated with the treatment. Significant cellular immune responses specific for the immunizing antigen and HER-2 sequences were induced after treatment, as measured by lymphocyte proliferation and interferon gamma enzyme-linked immunospot assay. One patient experienced a PR [partial response] lasting 6 months. Three additional patients had SD [stable disease] lasting more than 1 year.

Treatment With Autologous Antigen-Presenting Cells Activated With the HER-2 –Based….

Dendreon Corp released a statement today:

“In addition to demonstrating that NEUVENGE was safe and well tolerated, the T-cell responses seen in these patients and the prolonged disease stabilization in the absence of other anti-cancer therapies in many patients is promising,” said John W. Park, M.D., associate clinical professor of medicine and neurosurgery at the University of California, San Francisco and lead author of the publication. “These observations are encouraging and are suggestive of the clinical benefit of NEUVENGE, particularly in light of the aggressive cancer seen in these patients who had progressed while on standard therapy. The findings warrant additional studies of NEUVENGE for the many women with advanced breast cancer who have exhausted many of their treatment options.”

“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.”

Full release at Dendreon.com