CTI BioPharma has completed enrollment in the Phase 3 PIX306 trial of PIXUVRI (pixantrone).
The company said that the PIX306 trial is evaluating PIXVURI combined with rituximab in comparison to that of rituximab combined with gemcitabine in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). Patients eligible to be enrolled in the trial had failed front line CHOP-R and were not eligible for autologous stem cell transplant (ASCT) (2nd line) or failed ASCT (3rd or 4th line).
PIXUVRI has previously been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The trial is being conducted as a post-authorization requirement of conditional marketing authorization, the company said.
If positive, the results from this trial could support broader indications. Top-line results are event-driven and are expected in the first half of 2018.