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news.Seattle Genetics and Millennium: The Takeda Oncology Company have enrolled patients with high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT) in a Phase III AETHERA trial evaluating Adcetris (brentuximab vedotin).
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The randomised, double-blind trial will compare progression-free survival in 329 post-ASCT patients receiving Adcetris to those receiving placebo. Patients receive Adcetris every three weeks for up to one year.
The secondary endpoints of the placebo-controlled trial include overall survival, safety and tolerability.
Seattle Genetics chief medical officer Thomas Reynolds said Phase III trial will evaluate the use of Adcetris for Hodgkin lymphoma patients who are at increased risk of residual disease following an ASCT.
"The AETHERA trial is designed to provide the medical community with valuable insight into the potential for ADCETRIS to consolidate responses in Hodgkin lymphoma patients following a transplant, and will be the first data on the use of ADCETRIS in a maintenance-type setting," Reynolds added.
"We anticipate data from this trial will be available in late 2013 or early 2014."
Adcetris is an antibody-drug conjugate comprising an anti-CD30 monoclonal antibody attached to a microtubule disrupting agent, monomethyl auristatin E, by a protease-cleavable linker.