Phase III trial (PIX306) evaluating Pixuvri plus rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint. -CTI BioPharma + Servier.

CTI BioPharma Corp. and Servier announced that the pivotal Phase III trial (PIX306) evaluating Pixuvri (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of an improvement in progression-free survival (PFS).

Results from the study will be submitted to a peer-reviewed journal for publication. The PIX306 trial is a randomized, multicenter trial comparing pixantrone combined with rituximab versus gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL)

Pixuvri has conditional marketing authorization from the European Commission for prescription in the European Union (EU) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. Conditional marketing authorizations are granted in the EU if all the following requirements are met: the benefit-risk balance of the product is positive, it is likely that the applicant will be able to provide comprehensive data, unmet medical needs will be fulfilled, the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data. The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018.