Seattle Genetics, Takeda begin Phase III Lymphoma trial

Seattle Genetics, Takeda Pharmaceutical Co. and Millennium, Takeda’s oncology unit, have started a Phase III clinical trial of brentuximab vedotin (SGN-35) for post-transplant Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, which is expressed on malignant Hodgkin lymphoma cells. The trial, also known as AETHERA, will evaluate brentuximab vedotin versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT).

“Our initial approval strategy for brentuximab vedotin is based on our ongoing pivotal trial in relapsed and refractory Hodgkin lymphoma, from which data are expected in the second half of 2010. The pivotal trial is designed to form the basis for registrational filings with the FDA and EMA during the first half of 2011 under the accelerated approval and conditional authorization regulations respectively,” said Thomas C. Reynolds, M.D., Ph.D., chief medical officer of Seattle Genetics. The trial will also provide data on the use of brentuximab vedotin earlier in Hodgkin lymphoma therapy as part of an integrated second-line regimen with ASCT.

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.

Seattle Genetics has U.S. and Canadian commercialization rights to the drug, while 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.

The companies are also 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.