Seattle Genetics initiates phase III trial for SGN-35 (brentuximab vedotin)

Seattle Genetics, Inc, Takeda Pharmaceutical Company Limited and its wholly owned subsidiary Millennium: The Takeda Oncology Company announced today the initiation of an important phase III clinical trial of a highly anticipated treatment for Hodgkin's lymphoma.

TRIAL DETAILS

This phase III trial (known as AETHERA) is a randomized, double-blind, placebo-controlled trial that intends to put brentuximab vedotin (SGN-35) to the test against a placebo in treating patients "at high risk of residual Hodgkin lymphoma following autologous stem cell transplant."

Secondary endpoints: Overall survival, safety and tolerability.

COHORT

325 high-risk post-transplant patients with:
- a history of refractory Hodgkin lymphoma (relapsing within one year of receiving front-line chemotherapy)
- and/or those whose disease has spread beyond the lymph nodes at the time of pre-ASCT relapse

COMMENTARY & SOURCES

According to Seattle Genetics' Chief Medical Officer Thomas C. Reynolds, M.D., Ph.D., "The AETHERA trial is part of our broader development strategy and is designed to fulfill regulatory requirements for full approval in the United States and Europe. In addition, this trial will provide data on the use of brentuximab vedotin earlier in Hodgkin lymphoma therapy as part of an integrated second-line regimen with ASCT."

Source: Seattle Genetics