Seattle Genetics, Inc. (NASDAQ:SGEN) today announced that it has initiated a phase II clinical trial of ADCETRIS™ (brentuximab vedotin) for patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and other less common lymphoma subtypes. The trial is designed to assess the antitumor activity, duration of response and safety profile of ADCETRIS in these patients. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. On August 19, 2011, the U.S. Food and Drug Administration granted accelerated approval of ADCETRIS for two indications.
"This clinical trial is part of our comprehensive development plan to broadly evaluate the potential of ADCETRIS in CD30-positive malignancies, building on the data we have generated in certain patients with Hodgkin lymphoma and systemic ALCL," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "We believe the targeting ability of ADCETRIS to CD30 provides significant opportunities in selected lymphoma subtypes. This study and our other planned trials will further define the potential role of ADCETRIS in these patients."
The primary endpoint of the phase II trial is to determine the antitumor activity of ADCETRIS as measured by objective response rate. In addition, the trial will characterize the relationship of CD30 expression with antitumor activity. Eligible patients must have relapsed or refractory CD30-positive non-Hodgkin lymphoma, other than cutaneous or systemic anaplastic large cell lymphoma (ALCL). The study is expected to enroll up to approximately 55 patients at multiple centers in the United States.