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Lymphoma and Pets
Trial Begins Testing Adcetris in Post-Transplant Hodgkin's Patients
Seattle Genetics is announcing that they have completed patient enrollment for a Phase III clinical trial of the company's lead oncology treatment Adcetris (brentuximab vedotin) for post-transplant Hodgkin lymphoma (HL) patients.
This so-called AETHERA trial will evaluate Adcetris against placebo in treating patients at high risk of residual Hodgkin lymphoma following an autologous stem cell transplant (ASCT).
“We are pleased to complete the enrollment of this important phase III trial, evaluating the use of Adcetris for Hodgkin lymphoma patients who are at high risk of residual disease following an ASCT,” said Thomas C Reynolds, MD, PhD, chief medical officer of Seattle Genetics. “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. We anticipate data from this trial will be available in late 2013 or early 2014.”
Adcetris is a first-in-class antibody-drug conjugate (ADC) that targets the CD30 protein, a defining marker of classical HL.
About the phase III trial
AETHERA is a randomized, double-blind, placebo-controlled phase III study involving 329 post-transplant patients receiving either Adcetris or placebo.
Enrolled patients are considered at high risk for residual HL, which refers to those patients with a history of refractory HL, those who relapse or progress within one year from receiving front-line chemotherapy and/or those who have disease outside of the lymph nodes at the time of pre-ASCT relapse.
Primary endpoint is progression-free survival.
Secondary endpoints include overall survival, safety and tolerability. Patients receive Adcetris every three weeks for up to approximately one year. This international multi-center trial is being conducted in the United States, Europe and Russia.
Source: Seattle Genetics