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Seattle Genetics (SGEN) and Millennium Complete Enrollment for Phase III AETHERA Trial of ADCETRIS

September 25, 2012 9:11 AM EDT
Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium/ The Takeda Oncology Company today announced the completion of patient enrollment in a phase III clinical trial of ADCETRIS (brentuximab vedotin) for post-transplant Hodgkin lymphoma (HL) patients.

The phase III trial, also known as the AETHERA trial, is evaluating ADCETRIS 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) directed to CD30, a defining marker of classical HL.

The AETHERA trial is a randomized, double-blind, placebo-controlled phase III study, comparing progression-free survival in 329 post-ASCT patients receiving ADCETRIS to those receiving placebo. Patients must be at high risk for residual HL, defined as those 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. Secondary endpoints of the trial 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.


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