Takeda announces new data for Adcetris in Hodgkin lymphoma
Posted: 7 December 2015 | | No comments yet
Takeda presented long-term data from a Phase II and Phase III trial of Adcetris (brentuximab vedotin) at the 57th American Society of Hematology (ASH) annual meeting…
Takeda has announced post-treatment follow up data from the pivotal Phase 2 study of single-agent Adcetris (brentuximab vedotin) for the treatment of relapsed or refractory Hodgkin lymphoma following autologous stem cell transplantation (ASCT).
Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma.
The data, presented at the 57th American Society of Hematology (ASH) annual meeting, demonstrated that the estimated five-year overall survival (OS) rate among Adcetris-treated patients was 41 percent; median OS was 40.5 months and median progression-free survival (PFS) was 9.3 months. The safety profile of Adcetris 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 Adcetris as a standard of care for patients with Hodgkin lymphoma who experience relapse or disease progression following salvage therapy and ASCT.”
Adcetris showed positive long-term results in the AETHERA trial
Also presented today at the ASH annual meeting, data from the Phase 3 AETHERA trial of Adcetris consolidation therapy in Hodgkin lymphoma patients at high risk of relapse following ACST demonstrated that after three years of follow-up, patients treated with Adcetris continued to show a significant improvement in PFS per investigator assessment compared to placebo. The safety profile of Adcetris was generally consistent with the existing prescribing information.
Commenting on the data, Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company, said, “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.”
Adcetris is currently approved in more than 55 countries for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL).