Seattle Genetics, Millennium ADCETRIS phase I trial data on Hodgkin lymphoma presented at EHA

Jun 13 2011

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (Nasdaq: SGEN), announced today that data on ADCETRIS™ (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma patients were featured in an oral presentation at the 16^th Congress of the European Hematology Association (EHA) in London. The data from this retrospective analysis describe the activity and tolerability of ADCETRIS in Hodgkin lymphoma patients who were not candidates for or who refused autologous stem cell transplant (ASCT). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, the defining marker of Hodgkin lymphoma.

"These data from our phase I trials support the activity and tolerability of ADCETRIS in patients for whom standard second-line induction therapy is not an option or has failed to produce a robust response prior to ASCT," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer at Seattle Genetics. "We believe that patients in this setting represent a significant unmet medical need."

"Further analysis of data from these phase I trials continues to add to the growing body of evidence of the potential of ADCETRIS to benefit a variety of Hodgkin lymphoma patients, including those who have not received a stem cell transplant," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.

Twenty relapsed or refractory Hodgkin lymphoma patients who were ineligible for or refused treatment with ASCT were among patients enrolled in two phase I dose-escalation trials of ADCETRIS conducted from 2006 to 2010. Six out of 20 patients (30 percent) achieved an objective response, including two (10 percent) complete remissions and four (20 percent) partial remissions. An additional 10 patients (50 percent) had stable disease. The median duration of response had not been reached at the time the trials closed. Two patients who attained complete remission maintained their remission after 10.7 and 13.8 months of follow-up, respectively.

ADCETRIS treatment was generally well tolerated, with the most common adverse events being fatigue (45 percent), nausea (40 percent), fever (35 percent), weight loss (30 percent) and diarrhea (30 percent).