Results from the Aetheral Trial were presented this month at the 56th ASH Annual meeting and Exposition in San Francisco. AETHERA is a randomized, double-blind, placebo-controlled phase 3 study designed to evaluate overall survival, safety and tolerability of an agent called brentuximab vedotin in the treatment of patients at risk of progression following autologous stem cell transplant for Hodgkin’s Lymphoma.
Hodgkin’s Lymphoma (HL) is distinguished from other types of lymphoma (a group of cancers that originates in the lymphatic system) by the presence of one type of cell, called Reed-Sternberg cell that expresses CD30.
The American Cancer Society, estimates that in 2014 nearly 9,200 cases of HL will be diagnosed in the United States and more than 1,200 will die from the disease. Worldwide yearly estimations are of 62,000 cases of HL. The current “gold standard” treatment for chemosensitive relapsed/refractory HL is high-dose salvage chemotherapy plus autologous stem cell transplant (ASCT). This method is estimated to treat approximately 50% of HL cases.
In a recent press release Craig H. Moskowitz, MD, Clinical Director of the Division of Hematologic Oncology at Memorial Sloan Kettering Cancer Center said, “Immense progress has been made to reduce complications for transplant patients. For most people, a transplant can cure disease. But despite our best efforts, improvements in outcomes have plateaued and new therapies are needed.”
The compound brentuximab vedotin (ADCETRIS) combines an anti-CD30 antibody conjugated by a protease-cleavable linker to a microtubule-disrupting agent, monomethyl auristatin E (MMAE), and was shown to reach a response rate of 75% in patients with relapsed or refractory HL.
The AETHERA trial evaluated if early treatment with ADCETRIS could prevent disease progression in patients with HL that either relapsed or showed no response to prior treatment but were in remission or had stable, non-progressing disease after salvage chemotherapy prior to transplant.
A total of 329 patients were randomized from 78 sites in the United States, Eastern and Western Europe and Russia. Of these, 327 received treatment of brentuximab vedotin post-ASCT or a placebo. Results revealed that after 2 years, the group of patients that received BV treatment had a 20% improvement without disease progression compared to those that received a placebo (PFS rate of 65% vs. 45%).
Results also showed that 88% of the HL patients under BV treatment were still alive tat follow-up. Adverse events including peripheral sensory neuropathy, upper respiratory tract infection, neutropenia, and fatigue, where observed in less than 15 percent of patients.
“The results of this trial have the potential to change current practice. I am excited about the prospect of bringing this new therapy to all patients with hard-to-treat Hodgkin lymphoma,” Dr. Moskowitz added.