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ARTICLE | Clinical News

DN24-02: Preliminary Phase II data

June 17, 2013 7:00 AM UTC

Preliminary data from 45 evaluable patients with high-risk HER2-positive urothelial carcinoma in the open-label, U.S. Phase II NeuACT trial showed that 3 infusions of DN24-02 given at 2 week intervals were generally well tolerated with chills, fatigue, nausea, headache, vomiting and arthralgia reported as the most common adverse events. Additionally, DN24-02 led to significant increases in antibody levels, interferon (IFN) gamma responses and T cell proliferation at week 6 compared to baseline (p<0.01). Immune responses were comparable in patients who received prior neoadjuvant chemotherapy and in patients who did not. Dendreon also said that product potency of DN24-02 as determined by measuring the increase in cell surface expression of CD54 on antigen presenting cells was comparable to that of Provenge sipuleucel-T. The trial is comparing DN24-02 vs. standard of care in 180 patients with surgically resected HER2-positive urothelial carcinoma at high risk for recurrence. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...