New England Journal of Medicine publishes brentuximab vedotin Phase I clinical trial data

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced that data from a phase I single-agent clinical trial of brentuximab vedotin (SGN-35) will be published in the November 4, 2010 issue of the New England Journal of Medicine. The trial was designed to assess the safety and determine the maximum tolerated dose (MTD) of brentuximab vedotin in patients with CD30-positive hematologic malignancies, including Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL). Secondary endpoints included evaluation of antitumor activity, pharmacokinetics and immunogenicity. Brentuximab vedotin is a novel antibody-drug conjugate (ADC) targeting CD30, a marker for a number of malignancies including Hodgkin lymphoma and ALCL.

“We are pleased that these phase I data met the rigorous New England Journal of Medicine standards for publication”

"Brentuximab vedotin induced durable remissions with manageable side effects for a large segment of patients in this phase I experience," said Anas Younes, M.D., lead author of the publication, an investigator on the trial and Professor of Medicine and Director, Clinical and Translational Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. "In this study, we were able to identify the MTD and gain an understanding of the safety profile of brentuximab vedotin. There is a high unmet need for patients with Hodgkin lymphoma who relapse following autologous stem cell transplant, where overall survival is only 32 percent at five years. With a median age in the 30s for patients with relapsed Hodgkin lymphoma, these data suggest that brentuximab vedotin may be a promising new option to address the unmet need in these patients."

Highlights from the phase I trial include:

• Brentuximab vedotin was generally well-tolerated. Adverse events were mostly Grade 1 or 2, with the most common being fatigue, fever, diarrhea, nausea, neutropenia and peripheral neuropathy
• The MTD was 1.8 milligrams per kilogram (mg/kg) every three weeks
• At doses of 1.2 mg/kg and higher, 54 percent of evaluable patients (15 of 28) achieved an objective response per investigator assessment, including 39 percent (11 of 28) complete remissions
• The median duration of response was at least 9.7 months

"These phase I data provided the foundation for our current brentuximab vedotin clinical development program, including our pivotal trial in relapsed or refractory Hodgkin lymphoma and our phase II trial in relapsed or refractory ALCL, from which we recently reported positive top-line data," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "We remain focused on plans to submit our Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2011. In addition, we have a broad clinical development program of ongoing and planned clinical trials to evaluate the use of brentuximab vedotin in earlier lines of Hodgkin lymphoma and ALCL, as well as in other CD30-positive malignancies."

"We are pleased that these phase I data met the rigorous New England Journal of Medicine standards for publication," said Nancy Simonian, M.D., Chief Medical Officer of Millennium. "The impressive results from this study and the decision to publish this article reflects the continued interest among the scientific community in brentuximab vedotin."