Encouraging data from Seattle Genetics' phase I trial of brentuximab vedotin

Dec 7 2009

Seattle Genetics, Inc. (Nasdaq: SGEN) today reported data from a phase I weekly-dosing clinical trial of brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC), including multiple complete and partial remissions in patients with relapsed or refractory Hodgkin lymphoma or systemic anaplastic large cell lymphoma (ALCL). The data were presented at the American Society of Hematology (ASH) 51^st Annual Meeting being held in New Orleans, Louisiana.

“The encouraging data from this phase I trial in heavily pretreated lymphoma patients are consistent with the objective response rate observed in our every three week dosing phase I trial, and provide us with additional understanding about the single-agent dose, schedule and tolerability profile of brentuximab vedotin when administered weekly,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “These data reinforce our belief that brentuximab vedotin could play an important role in the treatment of Hodgkin and other CD30-positive lymphomas, and we are focused on bringing this ADC to patients as rapidly as possible. We expect data from our fully enrolled pivotal trial for relapsed and refractory Hodgkin lymphoma in the second half of 2010. If the data are supportive, we intend to use this trial as the basis for a new drug application (NDA) in the first half of 2011. We are also investigating the potential of brentuximab vedotin in other therapeutic settings, including an ongoing phase II single-agent trial for systemic ALCL and planned trials in earlier lines of therapy, such as combination regimens for Hodgkin lymphoma.”