Neuvenge (lapuleucel-T) / Sanpower - LARVOL DELTA

HER2 expression in patients (pts) with surgically resected urothelial cancer at high risk of recurrence screened for the phase II randomized, open-label trial of DN24-02, an autologous cellular immunotherapy targeting HER2 (ASCO-GU 2013) - P2, N=61; NCT01353222; Sponsor: Dendreon; "Twenty-three pts (38%) also had HER2 expression levels evaluated in tumor from involved lymph nodes. A total of 20 (87%; 95% CI: 66–97%) of these pts had a HER2 expression score of ≥1+ in the lymph nodes, with 12 (52%) having a ≥2+ score and 3 (15%) having a 3+ score. Two pts had primary tumor samples that expressed HER2 but were negative for HER2 expression in the lymph nodes submitted for analysis."

Biomarker • P2 data • Oncology

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma (clinicaltrials.gov) - P2; N=142; Completed; Sponsor: Dendreon; Active, not recruiting ➔ Completed; N=180 ➔ 142; Trial primary completion date: Jun 2016 ➔ Jul 2015

Clinical • Enrollment change • Trial completion • Trial primary completion date