In the current issue of the Journal of Clinical Oncology, cancer treatment biotechnology developer Dendreon published results from a Phase 1 study of Neuvenge, an investigational active cellular immunotherapy. The study includes the safety profile, immune response and clinical activity of the vaccine in women with her2/neu-positive breast cancer with whom standard therapy had failed.
Neuvenge will specifically target her2/neu-positive breast cancer, which affects between 20 percent and 30 percent of breast cancer patients.
The study had 19 patients enrolled with 18 patients receiving Neuvenge treatment, in order to evaluate the safety and immunologic activity of the vaccine. Patients underwent three infusions at Weeks 0, 2, and 4 following randomization. Those 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.
The researchers said the vaccine did not cause any serious side effects, and 22 percent of patients showed evidence of anti-cancer activity. At least one patient appeared to experience a partial response that lasted approximately six months, while three patients had their disease stabilize for more than a year without additional cancer therapy other than the continuation of bisphonates, according to the Seattle-based company.
Though the delay in approval of Provenge, another tailor-made Dendreon vaccine, has angered some patient advocacy groups, Dave Urdal, MD, chief scientific officer at Dendreon, said the completed data on Neuvenge would not be available any sooner than next year, and perhaps not until 2010.