Seattle Genetics presents SGN-35 study data in Hodgkin lymphoma at EBMT meeting

Apr 7 2011

Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that data from a case series of Hodgkin lymphoma patients receiving brentuximab vedotin (SGN-35) following allogeneic stem cell transplant were presented in an oral session at the European Group for Blood and Marrow Transplantation (EBMT) Annual Meeting in Paris, France. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma.

This is the first report of data from brentuximab vedotin in Hodgkin lymphoma patients who relapsed following allogeneic transplant. Patients in the company's pivotal Hodgkin lymphoma trial had all relapsed following autologous transplant, but none had received an allogeneic transplant. Patients relapsing following allogeneic transplant represent a particularly difficult therapeutic challenge. Key findings from this case series of 25 post-allogeneic transplant patients include:

• 50 percent of patients achieved an objective response (12 of 24 evaluable), including 38 percent complete remissions; an additional 42 percent of patients had stable disease
• Median progression-free survival (PFS) was 34 weeks; median overall survival had not been reached
• The median time to objective response was 8.1 weeks and patients received a median of 8 cycles of therapy; five patients remain on treatment
• Brentuximab vedotin administration was associated with manageable adverse events, with the most common being cough, fatigue, fever, nausea and peripheral sensory neuropathy
• The most common Grade 3 or higher adverse events were neutropenia, anemia, fatigue and fever

"Although allogeneic stem cell transplantation is the only potentially curative option at present for Hodgkin lymphoma patients who relapse following an autologous transplant, only 20 to 25 percent of these patients achieve long-term benefit," said Owen A. O'Connor, M.D., Ph.D., Professor, and Director, Division of Hematology and Medical Oncology at NYU Cancer Institute. "There are currently no good treatment options for Hodgkin lymphoma patients who fail allogeneic transplant. These data for brentuximab vedotin are encouraging in this post-transplant setting where there is a significant unmet medical need."

The case series comprises data from Hodgkin lymphoma patients who relapsed following allogeneic stem cell transplant that were enrolled in one of three multicenter, open label clinical trials of brentuximab vedotin. Patients received 1.2 or 1.8 milligrams per kilogram of brentuximab vedotin every three weeks. The median age of patients was 32 years. Enrolled patients had received a median of five prior therapeutic regimens, including 76 percent who had a prior autologous stem cell transplant.