Positive Data from Pivotal Phase III Study Could Improve Standard of Care for Hodgkin Lymphoma Patients


In a late-stage clinical trial, Hodgkin lymphoma (HL) patients who received brentuximab vedotin (BV) post-transplant lived longer without disease progression than patients who received only supportive care. This is the first time a study has demonstrated that adding a maintenance therapy after transplant can improve outcomes. The study, led by Craig H. Moskowitz, MD, Clinical Director of the Division of Hematologic Oncology at Memorial Sloan Kettering Cancer Center, was presented today at the 56th Annual Meeting of the American Society of Hematology.

For the past 20 years, high doses of chemotherapy followed by an autologous transplant — a procedure in which a patient’s own blood-forming stem cells are collected and then transplanted back into the patient to produce new, healthy blood cells — has been the standard of care for patients with HL who have relapsed or did not respond to initial therapy. This treatment approach typically cures about half of patients. For the other half of patients who remain at risk of disease progression after transplant, there is currently no standard therapy.

“Immense progress has been made to reduce complications for transplant patients,” said Dr. Moskowitz. “For most people, a transplant can cure disease. But despite our best efforts, improvements in outcomes have plateaued and new therapies are needed.”

BV is an antibody that targets the CD30 protein, which is found on HL cells. A total of 327 patients were randomized to receive either the drug or best supportive care after transplant. All patients had either relapsed or failed to respond to at least one prior therapy but were in remission or had stable, non-progressing disease after salvage chemotherapy prior to transplant.

After a median follow-up of two years, patients who received BV had a 20 percent improvement without disease progression compared to those who did not receive the drug (progression-free survival rate of 65 percent vs. 45 percent); 88 percent of patients who received BV are still alive. Adverse events occurred in less than 15 percent of patients and included peripheral sensory neuropathy, upper respiratory tract infection, neutropenia, and fatigue.

“The results of this trial have the potential to change current practice,” said Dr. Moskowitz. “I am excited about the prospect of bringing this new therapy to all patients with hard-to-treat Hodgkin lymphoma.”

Abstract #673: 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