Seattle Genetics and Millennium: The Takeda Oncology Company have completed enrollment in a Phase III AETHERA trial evaluating Adcetris (brentuximab vedotin) versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT).
Adcetris is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached to a microtubule disrupting agent, monomethyl auristatin E (MMAE), by a protease-cleavable linker, leveraging Seattle Genetics' proprietary technology.
Seattle Genetics chief medical officer Thomas Reynolds said the 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 said.
"We anticipate data from this trial will be available in late 2013 or early 2014."
The randomised, double-blind trial is assessing progression-free survival in 329 post-ASCT patients, who are at high risk for residual HL, receiving Adcetris compared 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.
Millennium chief medical officer Karen Ferrante said; "We look forward to continuing to work with our partner Seattle Genetics to determine the potential benefit of this targeted treatment in other CD30-expressing tumours."