Following treatment with high-dose chemotherapy and stem cell transplant, patients with relapsed and difficult-to-treat Hodgkin lymphoma who received Adcetris (brentuximab vedotin) had an unprecedented 50 percent higher likelihood of continuing to experience progression-free survival (PFS) at two years.
This is particularly meaningful because most patients in this population whose cancers haven’t relapsed two years after transplant are cured. The study’s lead author, Craig Moskowitz, of Memorial Sloan Kettering Cancer Center, reported those results from the phase 3 AETHERA trial at the 2014 annual meeting of the American Society of Hematology (ASH).
While roughly half of patients with this condition are cured through the administration of high-dose chemotherapy and stem cell transplant, maintenance strategies to prolong good health afterward are needed because many others relapse, Moskowitz said.
Adcetris is an antibody that targets the CD30 protein on Hodgkin lymphoma cells. The drug has demonstrated an objective response rate of 75 percent in Hodgkin lymphoma that has relapsed or become refractory after autologous stem cell transplant; the AETHERA trial was initiated to evaluate whether early treatment with Adcetris after transplant could prevent progression in patients with Hodgkin lymphoma, the authors wrote in the abstract presented at ASH. The drug was approved by the Food and Drug Administration in August 2011 for the treatment of patients with Hodgkin lymphoma after failure of stem cell transplant, or failure of at least two prior multi-agent chemotherapy regimens in patients who are not candidates for transplant.
Simultaneously, it was approved for use in patients who have systemic anaplastic large cell lymphoma after the failure of at least one prior multi-agent chemotherapy regimen.
“This is the first study in lymphoma to demonstrate that the addition of a maintenance drug after transplant can markedly improve patient outcomes,” Moskowitz said. “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.”
The randomized, multicenter study compared Adcetris with placebo in 327 patients who had been treated with a minimum of two prior systemic therapies and faced a risk of post-transplant disease progression. All had either achieved remission or had stable, non-progressing disease at the time of stem cell transplant, according to the abstract. Thirty to 45 days after transplant, patients were randomized to receive best supportive care plus Adcetris or placebo every three weeks for up to 16 cycles.