Positive results from pivotal trial of SGN-35 in refractory Hodgkin lymphoma presented at ASH 2010

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 results from the pivotal trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory Hodgkin lymphoma. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of Hodgkin lymphoma. The data were featured during a press briefing today at the 52^nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL and will be presented during an oral session on Monday, December 6, 2010, at 7:00 a.m. Eastern Time.

“I have rarely seen such response rates in this relapsed or refractory disease population”

Key findings from the trial in 102 relapsed or refractory Hodgkin lymphoma patients included:

• 75 percent of patients achieved an objective response as assessed by an independent central review using the stringent Cheson 2007 criteria, the primary endpoint of the trial.
• 34 percent of patients achieved a complete remission.
• The median duration of response was 29 weeks by independent central review and 47 weeks by investigator assessment.
• Among patients achieving a complete remission, the median duration of response had not yet been reached at a median follow-up of approximately one year.
• Tumor reductions were achieved in 94 percent of patients.
• Brentuximab vedotin treatment was associated with manageable adverse events, with the most common being peripheral sensory neuropathy, fatigue, nausea, upper respiratory tract infection and diarrhea. The most common Grade 3 or higher adverse events were neutropenia, peripheral sensory neuropathy, thrombocytopenia and anemia.

"Up to thirty percent of all patients diagnosed with Hodgkin lymphoma will relapse. These patients have limited treatment options beyond autologous stem cell transplantation and represent a significant unmet medical need," said Dr. Robert Chen, Assistant Professor, Hematology & Hematopoietic Cell Transplantation at City of Hope. "Based on these data, brentuximab vedotin has the potential to change the treatment paradigm for relapsed or refractory Hodgkin lymphoma patients, and could be the first treatment approved for these patients in more than 20 years."

"I have rarely seen such response rates in this relapsed or refractory disease population," said Dr. Andreas Engert, Professor of Internal Medicine, University of Cologne, Germany. "These data highlight brentuximab vedotin as a potential addition to the treatment options for Hodgkin lymphoma patients."

Based on recent discussions with the U.S. Food and Drug Administration (FDA), Seattle Genetics plans to submit a Biologics License Application (BLA) in the first quarter of 2011 to seek approval for both relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Millennium has initiated discussions with European regulators to support the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2011. In addition, in early 2011, Seattle Genetics plans to implement a limited patient access program for qualified relapsed or refractory Hodgkin lymphoma and systemic ALCL patients in the United States. Outside of the United States and Canada, brentuximab vedotin will be made available to qualified relapsed or refractory Hodgkin lymphoma and systemic ALCL patients through a Named Patient Program (NPP). An NPP is a compassionate use drug supply program under which medical practitioners can legally supply investigational drugs to their eligible patients.