This article is more than 5 years old. Information may no longer be current.
Pixuvri combination fails to prolong PFS in aggressive B-cell non-Hodgkin lymphoma
Click Here to Manage Email Alerts
A randomized phase 3 trial designed to compare the combination of pixantrone and rituximab failed to significantly extend PFS compared with gemcitabine plus rituximab for certain patients with aggressive B-cell non-Hodgkin lymphoma.
Pixantrone (Pixuvri; CTI BioPharma and Servier) is a cytotoxic medicine that interferes with DNA within cells, preventing them from making more copies of DNA. Consequently, cancer cells cannot divide and eventually die.
Pixantrone is approved in the European Union for monotherapy of adults with relapsed or refractory aggressive non-Hodgkin B-cell lymphoma; however, the agent, is not approved in the United States.
The multicenter PIX306 trial included 312 patients with aggressive B-cell non-Hodgkin lymphoma who relapsed after CHOP-R or an equivalent regimen and were not eligible for stem cell transplant.
Patients received pixantrone plus rituximab (Rituxan; Genentech, Biogen) or a gemcitabine-rituximab combination. PFS served as the primary endpoint. Secondary endpoints included OS, complete response rate, overall response rate and safety.
“We are disappointed with the outcome of the PIX306 trial and will proceed to conduct a thorough review of clinical data to assess the next steps for the Pixuvri program,” Adam Craig, MD, PhD, CEO of CTI BioPharma, said in a company-issued press release.
Complete study results will be submitted for publication in a peer-reviewed journal.