Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, today announced positive interim results from a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) plinabulin (NPI-2358) in combination with standard chemotherapy (docetaxel) in patients with advanced non-small cell lung cancer (NSCLC). This data is consistent with the favorable outcomes seen in the Phase 1 portion of the study, which assessed the safety, pharmacokinetics and efficacy of the combination.
The ADVANCE (Assessment of Docetaxel and Vascular Disruption in Non-Small Cell Lung Cancer) trial is investigating plinabulin in combination with docetaxel compared to docetaxel alone in patients with advanced NSCLC who previously failed at least one prior chemotherapy regimen. Overall survival is the primary endpoint of the trial, and progression free survival and tumor response rates are being evaluated as secondary endpoints. Approximately 150 patients are expected to participate in the study at clinical trial sites in the U.S., Australia, India, and South America, of which 110 have been enrolled.