Preliminary product parameter and safety results from NeuACT, a phase 2 randomized, open-label trial of DN24-02 in patients with surgically resected HER2+ urothelial cancer at high risk for recurrence.

4541^ Background: DN24-02 is an investigational HER2-targeted autologous cellular immunotherapy (ACI) based on the same manufacturing platform as sipuleucel-T, an ACI approved by the FDA and EMA for certain patients (pts) with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. DN24-02 consists of antigen presenting cells (APC) cultured with BA7072, a recombinant HER2-derived antigen (HER500) linked to GM-CSF. NeuACT (N10-1; NCT01353222) compares the efficacy and safety of adjuvant DN24-02 to surveillance in HER2+ urothelial cancer (UC) pts at high risk of relapse after resection. Preliminary product potency, immune response and safety data are reported. Methods: Pts randomized to DN24-02 received 3 infusions at 2 week intervals. Primary endpoint is overall survival. Secondary objectives include disease-free survival, antigen-specific immune response, product potency (measured by APC activation) and safety. Results: As of November 2013, 38 pts completed DN24-02 infusions...