Positive data on retreatment with brentuximab vedotin in Hodgkin lymphoma, ALCL presented at ASCO

Seattle Genetics, Inc. (Nasdaq:SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today reported data on Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL) patients retreated with single-agent brentuximab vedotin (SGN-35). Preliminary data demonstrate that objective responses were achieved in seven out of 11 retreatment experiences and that brentuximab vedotin was well-tolerated in the retreatment setting. The data were presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Illinois.

“These preliminary data are supportive of the steps we are taking to bring brentuximab vedotin to those patients with Hodgkin lymphoma or ALCL who have limited treatment options.”

"We are encouraged that more than half of the patients in this retreatment case series obtained objective responses with brentuximab vedotin," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "Through our broad ongoing clinical development program, our goal is to continue to build on our understanding of brentuximab vedotin's potential to address the medical needs of Hodgkin lymphoma and ALCL patients who have limited therapeutic alternatives."

"We have seen the clinical strength of brentuximab vedotin in a variety of treatment settings, and these positive retreatment data provide additional evidence of its potential for patients who relapse," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "These preliminary data are supportive of the steps we are taking to bring brentuximab vedotin to those patients with Hodgkin lymphoma or ALCL who have limited treatment options."

Data from 11 retreatment experiences with brentuximab vedotin were presented, including nine from patients with Hodgkin lymphoma and two from patients with systemic ALCL. Patients were heavily pretreated with a range of two to 11 prior therapies. Five patients had received a prior autologous stem cell transplant. Patients had achieved stable disease with decreasing tumor volume or better during prior brentuximab vedotin treatment, discontinued treatment and subsequently experienced disease progression.

In these 11 retreatment experiences, objective responses were achieved in seven cases (64 percent), including two complete remissions and five partial remissions. Time to objective response ranged from five to 15 weeks. Three experiences resulted in stable disease and one in progressive disease. The duration of retreatment objective responses ranged from less than one week (retreatment ongoing) to 58+ weeks. Based on the small sample size, no difference in duration of retreatment response between patients with Hodgkin lymphoma and ALCL was observed. Retreatment is ongoing in three patients. Tumor reductions were observed in ten out of 11 retreatment cases. Brentuximab vedotin was well tolerated in the retreatment setting. All drug-related adverse events were Grade 1 or 2, with the most common being peripheral neuropathy, hair loss, joint pain and injection site irritation (Abstract #8062).