Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced positive top-line results from the pivotal trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.
“These data have the potential to provide an important advance in therapy for Hodgkin lymphoma. We intend to discuss these results with European regulators to support our goal of submitting a Marketing Authorization Application to the European Medicines Agency (EMA) in 2011.”
Seventy-five percent of patients in the pivotal trial achieved an objective response as assessed by an independent central review, the primary endpoint of the trial. The median duration of response was greater than six months. The safety profile of brentuximab vedotin in this trial was generally consistent with prior clinical trial experience. A more complete data set will be presented at an upcoming scientific meeting.
"We are extremely excited with the top-line results, as they move us one step closer to our goal of bringing brentuximab vedotin to patients with relapsed or refractory Hodgkin lymphoma," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are positioned for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011. In addition, we plan to report top-line data from our phase II trial of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) within the next few weeks."
"The lack of adequate therapies for the treatment of relapsed and refractory Hodgkin lymphoma represents a substantial unmet medical need worldwide, with almost a third of the 30,000 newly diagnosed patients relapsing or becoming refractory to front-line therapy annually," said Nancy Simonian, M.D., Chief Medical Officer of Millennium. "These data have the potential to provide an important advance in therapy for Hodgkin lymphoma. We intend to discuss these results with European regulators to support our goal of submitting a Marketing Authorization Application to the European Medicines Agency (EMA) in 2011."