Description
Brentuximab vedotin is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody linked to monomethyl auristatin E (MMAE). The target, CD30, is expressed on Hodgkin lymphoma, various T-cell cancers and other hematologic malignancies. Brentuximab vedotin may also have applications in autoimmune disease due to CD30 expression on activated, but not resting, T-cells.

Status
We are conducting a pivotal trial of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma under a Special Protocol Assessment with the FDA. The trial, which is being conducted at multiple sites in the United States, Canada and Europe, reached its target enrollment of 100 patients in August 2009. Top-line data from the trial are expected to be reported in the late September to October 2010 timeframe. Our goal is to submit a New Drug Application (NDA) with the FDA under the accelerated approval regulations in the first half of 2011.

In April 2010, we initiated the phase III AETHERA trial to evaluate brentuximab vedotin versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following ASCT. It is a randomized, double-blind study that is expected to enroll approximately 325 post-ASCT patients. The primary endpoint is progression-free survival. The AETHERA trial is designed to fulfill regulatory requirements for full approval in the United States and Europe.

We are also conducting a phase II clinical trial of brentuximab vedotin in patients with relapsed or refractory systemic ALCL; enrollment to this trial is complete. Interim top-line data from the trial are expected to be reported in the late September to October 2010 timeframe. Systemic ALCL may provide an additional registration pathway for brentuximab vedotin. In addition, we are advancing a phase II trial evaluating tolerability and activity when retreating patients who relapse after previously achieving an objective response to brentuximab vedotin as well as a phase I trial to assess the safety and tolerability of brentuximab vedotin in combination with chemotherapy for the front-line treatment of Hodgkin lymphoma.

In December 2009, Seattle Genetics entered into a collaboration with Millennium: The Takeda Oncology Company for the global development and commercialization of brentuximab vedotin. Under the agreement, Seattle Genetics retained rights to commercialize brentuximab vedotin in the United States and Canada. Millennium has exclusive rights to commercialize the product candidate in the rest of the world.

Brentuximab vedotin has received orphan drug designation in the United States and Europe for both Hodgkin lymphoma and ALCL. We also have obtained Fast Track designation from the FDA for brentuximab vedotin in Hodgkin lymphoma.