The AETHERA trial is a randomized, double-blind, placebo-controlled phase III study comparing progression-free survival in approximately 325 post-ASCT patients receiving brentuximab vedotin to those receiving placebo. Patients must be at high risk for residual Hodgkin lymphoma, defined as those with a history of refractory Hodgkin lymphoma, 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 will receive brentuximab vedotin every three weeks for up to approximately one year. This international multi-center trial will be conducted in the United States, Europe and Russia.

Seattle Genetics is developing brentuximab vedotin in collaboration with Millennium, under which Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Under the collaboration, Seattle Genetics and Millennium are conducting a pivotal trial of brentuximab vedotin for relapsed and refractory Hodgkin lymphoma under a Special Protocol Assessment (SPA) with the FDA, and top-line data are expected in the second half of 2010. The pivotal trial also received EU Centralized Scientific Advice from the EMA. The pivotal trial is designed to form the basis for registrational filings with the FDA and EMA under the accelerated approval and conditional authorization regulations. These regulations provide a mechanism for making promising products for life-threatening diseases commercially available on the basis of preliminary evidence prior to formal demonstration of patient benefit.

In addition, the companies are conducting a phase II trial for relapsed and refractory systemic anaplastic large cell lymphoma, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin therapy, and a phase I combination trial for front-line Hodgkin lymphoma.

SOURCE Seattle Genetics