Opaxio misses primary endpoint in Ph III study

US drug developer Cell Therapeutics saw mixed results from a Phase III trial comparing Opaxio (paclitaxel poliglumex) with gemcitabine or vinorelbine for performance status 2 patients with previously-untreated non-small cell lung cancer published in the July 7 issue of the Journal of Thoracic Oncology.

The drug failed to achieve the primary endpoint in the late-stage study, known as STELLAR 4, which was improvement in overall survival versus standard single-agent treatments of gemcitabine or vinorelbine. The firm noted that the agent did demonstrate similar overall survival and a reduction in the supportive care required by patients. According to the Seattle-headquartered firm, patients on Opaxio required fewer red blood cell transfusions, hematopoietic growth factors and opioid analgesics than those receiving either gemcitabine or vinorelbine. There were relatively few non-hematopoietic grade 3 or 4 toxicities in either arm.