Seattle Genetics and Takeda announced results from the Phase 3 AETHERA trial with Adcetris (brentuximab vedotin) in patients with post-transplant Hodgkin lymphoma. Adcetris is an antibody-drug conjugate (ADC) designed to be stable in the bloodstream but to release monomethyl auristatin E upon internalization into CD30-expressing tumor cells.
The AETHERA trial is a randomized, double-blind, placebo-controlled study designed to evaluate the use of Adcetris to extend progression-free survival (PFS) in post-autologous stem cell transplantation (ASCT) in 329 patients with Hodgkin lymphoma who have at least one risk factor for progression. The primary endpoint was progression-free survival.
Patients who received Adcetris as consolidation therapy immediately following an ASCT lived significantly longer without disease progression compared to patients who received placebo. The AETHERA trial met its primary endpoint with Adcetris treatment resulting in a statistically significant improvement in progression-free survival (PFS) vs. placebo (HR=0.57; P=0.001), which equates to a 75% improvement in PFS.
Adcetris is already approved for the treatment of Hodgkin lymphoma after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. Treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.