Custirsen sodium: Phase III data

Top-line data from the open-label, international Phase III AFFINITY trial in 634 patients with metastatic CRPC who progressed after first-line treatment with docetaxel showed that once-weekly 640 mg IV custirsen following 3 loading doses plus Jevtana cabazitaxel and prednisone missed the primary endpoint of improving OS vs. Jevtana plus prednisone alone. OncoGenex plans to present final data next month at the European Society for Medical Oncology meeting in Copenhagen. Based on the data, the company said it plans to initiate discussions with FDA to evaluate options for an early analysis of the Phase III ENSPIRIT trial evaluating custirsen plus docetaxel as second-line treatment of non-small cell lung cancer (NSCLC). ...