Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

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 data from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of ALCL. The data were presented today during an oral session at the 52^nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.

“There have been no major treatment advances in relapsed or refractory ALCL in many years. We are excited by the potential of adding brentuximab vedotin to the armamentarium of treatment options.”

Key findings from the trial in 58 relapsed or refractory ALCL patients included:

• 86 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.
• 53 percent of patients achieved a complete remission.
• The median duration of response by independent assessment had not yet been reached at a median follow up on study of six months.
• Tumor reductions were achieved in 97 percent of patients.
• Brentuximab vedotin treatment was associated with manageable adverse events, with the most common being nausea, peripheral sensory neuropathy, fatigue, fever and diarrhea. The most common Grade 3 or higher adverse events were neutropenia, peripheral sensory neuropathy, thrombocytopenia and anemia.

"Nearly all patients in this trial had reductions in tumor volume, including a remarkable rate of complete remissions," said Dr. Andrei Shustov, assistant professor of Hematology at the University of Washington School of Medicine and attending physician in the Hematologic Malignancies Program at the Seattle Cancer Care Alliance. "This suggests that brentuximab vedotin has the potential to provide a promising new treatment option for patients with relapsed or refractory systemic ALCL. The data are also supportive of continued clinical evaluation of brentuximab vedotin in earlier lines of ALCL treatment, and in other CD30-positive malignancies."

"Single-agent activity of this magnitude is rarely seen in oncology. It is particularly impressive when demonstrated in a pretreated disease population," said Dr. Pier Zinzani, Associate Professor, Institute of Hematology "Seràgnoli" University of Bologna, Italy. "There have been no major treatment advances in relapsed or refractory ALCL in many years. We are excited by the potential of adding brentuximab vedotin to the armamentarium of treatment options."

Seattle Genetics plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2011, and seek approval for both relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic ALCL. Millennium has initiated discussions with European regulators to support the submission of a Marketing Authorization Application 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.