New data announced at the 57th American Society of Hematology (ASH) annual meeting in Orlando, FL show the results of the post-treatment follow up data from the pivotal phase 2 study of single-agent brentuximab vedotin for the treatment of relapsed or refractory Hodgkin lymphoma following autologous stem cell transplantation (ASCT). 

The data demonstrated that the estimated five-year overall survival (OS) rate among brentuximab vedotin treated patients was 41 percent (95% CI: 31%, 51%); median OS was 40.5 months (95% CI: 28.7, 61.9 [range 1.8 to 72.9 ]) and median progression-free survival (PFS) was 9.3 months (95% CI: 7.1 to 12.2 months).

The safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

“The five year overall survival rates reported in this pivotal trial are very promising in improving the long-term outlook for patients in this setting as outcomes have historically been very poor,” said Professor Andreas Engert, M.D., University Hospital of Cologne, Germany.

“These data further reinforce the emergence of brentuximab vedotin as a standard of care for patients with Hodgkin lymphoma who experience relapse or disease progression following salvage therapy and ASCT.”

Also presented today at the ASH annual meeting, data from the phase 3 AETHERA trial of brentuximab vedotin consolidation therapy in Hodgkin lymphoma patients at high risk of relapse following ACST demonstrated that after three years of follow-up, patients treated with brentuximab vedotin continued to show a significant improvement in PFS per investigator assessment (61%; 95% CI:53%, 68% HR 0.52) compared to placebo (43%; 95% CI:36%, 51% HR 0.52). The safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma.

Brentuximab vedotin is currently approved in more than 55 countries for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL).

The utility of brentuximab vedotin is currently being explored across a number of types of cancer, and data from six studies in the brentuximab vedotin clinical trial program were presented at the ASH meeting, including four as oral presentations.

“With more than 45 clinical trials across multiple lines of therapy underway and ongoing research focused on understanding the underlying pathogenesis of Hodgkin lymphoma, our commitment to advancing the care of people battling this disease is far-reaching,” said Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company.

“The positive long-term results from these two pivotal studies are very important in our work to advance the care of people living with Hodgkin lymphoma whose disease has progressed.”

Source: ASH 2015