SAN FRANCISCO—Treatment with brentuximab vedotin in patients with Hodgkin lymphoma at risk for progression following autologous stem cell transplantation (ASCT) resulted in a median progression-free survival of 43 months versus 24 months on placebo, an analysis of blinded pooled efficacy data of the AETHERA trial (Abstract 673) presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition has shown.
For the international, multicenter, double-blind, placebo-controlled phase 3 study, 329 patients with Hodgkin lymphoma who underwent ASCT after obtaining a complete response, partial remission, or stable disease to salvage therapy were randomly assigned to receive best supportive care plus brentuximab vedotin 1.8 mg/kg every 3 weeks or placebo for up to 16 cycles.
Of the 165 assigned to receive brentuximab vedotin, 43% had received at least two prior cancer-related systemic salvage therapies and 60% were refractory to frontline therapy. Patients received a mean of 12 cycles of brentuximab vedotin and 11 cycles of placebo.
Results showed that of the 327 patients who received study treatment, the median progression-free survival per independent review facility (IRF) was 43 months for patients who received brentuximab vedotin compared with 24 months for those who received placebo (hazard ratio [HR]=0.57; P0.001).
In addition, the 2-year progression-free survival rate per IRF was 63% for brentuximab vedotin versus 51% for placebo. Overall survival data are currently immature and further analysis will be conducted in 2016, but an interim analysis showed no significant different between treatment arms (P=0.62).
“I suspect that 65% of patients in the brentuximab vedotin arm will be cured of their Hodgkin lymphoma compared with 45% in the placebo arm,” said Craig H. Moskowitz, MD, of Memorial Sloan Kettering Cancer Center in New York, NY, while presenting at the meeting.
The most common adverse effects (>20%) reported in patients on brentuximab vedotin were peripheral sensory neuropathy, neutropenia, upper respiratory tract infection, fatigue, and peripheral motor neuropathy. The most common grade 3 or higher adverse effects were neutropenia, peripheral sensory neuropathy, peripheral motor neuropathy, nausea, fatigue, and diarrhea.
Of those who experienced peripheral neuropathy on brentuximab vedotin, 85% had resolution or improvement in symptoms in a median of 23.4 weeks.
“We believe that brentuximab vedotin consolidation is an important therapeutic option for Hodgkin lymphoma patients undergoing ASCT to reduce the risk of relapse,” Dr. Moskowitz concluded. “I do believe this will become standard treatment.”
Brentuximab vedotin (Adectris®) is an CD30-directed antibody-drug conjugate already approved by the U.S. Food and Drug Administration for the treatment of Hodgkin lymphoma after failure of ASCT or after at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and for systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
- Moskowitz, Craig H., MD, et al. “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.” ASH 2014. Oral Presentation. December 8, 2014.