The US Food and Drug Administration recently granted brentuximab vedotin by Adcetris approval as a post-autologous hematopoietic stem cell transplantation consolidation for patients with classical Hodgkin’s lymphoma assessed to have a higher risk for relapse or progression.
This approval is based largely on the favorable findings of the drug’s Phase III ATHERA clinical trial, which was reported in the journal The Lancet and presented during last year’s American Society of Hematology Annual Meeting and Exposition in December. The study sought to compare the drug versus a placebo after patients underwent autologous hematopoietic stem cell transplantation, and enrolled 329 Hodgkin’s lymphoma patients with a high-risk for relapse or disease progression. Out of the total number of participants, 165 were treated with 16 cycles of brentuximab vedotin every 3 weeks, while the remaining were given a placebo.
The study achieved its primary endpoint with an average improvement in PFS of 18.8 (HR = 0.57; 95% CI, 0.4-0.81). Patients who received the drug had a PFS improvement of 42.9 months (95% CI, 30.4-42.9), while those on a placebo registered an average PFS of 24.1 months (95% CI, 11.5 to not estimable).
Brentuximab vedotin received FDA approval in August 2011 as a treatment for Hodgkin’s lymphoma patients who failed autologous transplant or failed at least two prior multi-agent chemotherapy regimens and who were not autologous transplant candidates. The drug was also FDA-approved for use in patients with systemic anaplastic large cell lymphoma who failed at least one prior multi-agent chemotherapy regimen.
“The FDA approval of brentuximab vedotin for post-autologous hematopoietic transplantation consolidation treatment in classical Hodgkin’s lymphoma patients with high risk of relapse or progression is a significant milestone for patients and physicians,” Craig Moskowitz, MD, lead investigator on the ATHERA trial, clinical director of the division of hematologic oncology at Memorial Sloan Kettering Cancer Center and a HemOnc Today Editorial Board member, said in a press release. “Approximately half of all Hodgkin’s lymphoma patients who undergo an autologous hematopoietic stem cell transplant will relapse, representing a significant need for additional treatment options to improve PFS.”