The AETHERA Trial: Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Brentuximab Vedotin in the Treatment of Patients at Risk of Progression Following Autologous Stem Cell Transplant for Hodgkin Lymphoma.
Roughly half of patients with relapsed and hard-to-treat Hodgkin lymphoma respond to a combination of high-dose therapy and autologous stem cell transplant, a procedure in which healthy cells are taken from the patient’s own blood or bone marrow to effectively “replace” damaged cells. Unfortunately, many patients still experience recurrence of disease after undergoing this intense procedure.
This Phase III, randomized, multi-center study compared brentuximab vedotin (BV), an antibody targeting the CD30 protein on Hodgkin lymphoma cells, with placebo in 327 patients at risk of post-transplant disease progression. All trial participants had either achieved remission or had stable, non-progressing disease at time of transplant.
Between 30 and 45 days after transplant, patients were randomized to receive either BV or placebo for up to one year. After a median of two years of follow up, researchers observed that patients receiving BV had a 20 percent improvement without disease progression compared to patients receiving placebo (progression-free survival rate of 65% vs. 45%) The safety profile was generally consistent with existing prescribing information. The most common events associated with BV included peripheral sensory neuropathy, upper respiratory tract infection, and neutropenia.
“This is the first study in lymphoma to demonstrate that the addition of a maintenance drug after transplant can markedly improve patient outcomes,” said lead study author Craig Moskowitz, MD, of Memorial Sloan Kettering Cancer Center in New York. “Given these extremely positive results, we predict that brentuximab vedotin will soon become the standard of care for Hodgkin lymphoma patients who undergo an autologous stem cell transplant.”