Progression-free survival in Hodgkin lymphoma patients has been boosted when they take Adcetris (brentuximab vedotin), Phase III data from Takeda UK shows.
When compared with placebo, those patients at risk of relapse following an autologous stem cell transplant had significant improvement in progression-free survival when receiving Adcetris as consolidation therapy immediately after ASCT. The findings come from the AETHERA trial.
Adcetris is an antibody-drug conjugate directed to CD30, a defining marker of classical HL. It has been approved in more than 45 countries for the treatment of relapsed or refractory HL and relapsed or refractory systemic anaplastic large cell lymphoma and is currently not approved in the AETHERA treatment setting.
“The AETHERA trial is the first Phase III, comparative clinical trial for brentuximab vedotin and the positive results from this study establish the ability of brentuximab vedotin to prolong progression-free survival in patients with high risk Hodgkin Lymphoma who are undergoing an autologous stem cell transplant,” said Karl Peggs, reader in stem cell transplantation and immunotherapy, University College London. “The data suggest that some patients with high risk Hodgkin Lymphoma who are undergoing an autologous stem cell transplant may derive clinical benefit from consolidation treatment with brentuximab vedotin.”
“The AETHERA data provide compelling evidence regarding the potential utility of brentuximab vedotin as consolidation therapy post-transplant in these Hodgkin lymphoma patients, and we look forward to submitting these data to health authorities around the world,” said Michael Vasconcelles, global head, oncology therapeutic area unit, Takeda. “Going forward, we are conducting a robust clinical development programme to more fully understand the potential of CD30 targeting with brentuximab vedotin in frontline disease through our ongoing Phase III ECHELON-1 and ECHELON-2 trials in HL and mature T-cell lymphomas.”
The Phase III AETHERA trial was designed to evaluate the potential of single agent brentuximab vedotin to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival, safety and tolerability. Eligible patients must have had a history of refractory HL, have relapsed within one year from receiving frontline chemotherapy and/or have had disease outside of the lymph nodes at the time of pre-ASCT relapse. These factors are consistently reported to be associated with poor prognosis after transplant. Patients received brentuximab vedotin or placebo every three weeks for up to approximately one year. This international multi-centre trial was conducted at 78 sites in the United States, Eastern and Western Europe and Russia.