Updated phase III results for Adcetris (brentuximab vedotin) in Hodgkin lymphoma post transplant- Takeda

According to new data presented at the ASH annual meeting, the phase III AETHERA trial of Adcetris (brentuximab vedotin), from Takeda, in Hodgkin lymphoma patients at high risk of relapse following ACST demonstrated that after three years of follow-up, patients treated with brentuximab vedotin continued to show a significant improvement in PFS per investigator assessment (61%) compared to placebo (43%). The safety profile of Adcetris was generally consistent with the existing prescribing information.

At three years, treatment-emergent peripheral neuropathy resolved for most patients, and no additional secondary malignancies were observed in either treatment arm. Among the 112 patients in the brentuximab vedotin arm who experienced treatment-emergent peripheral neuropathy, 99 patients (88%) experienced some improvement (23%) or complete resolution (65%) of neuropathy symptoms at the time of analysis. Secondary malignancies were comparable between the two treatment arms (n=4 brentuximab vedotin, n=2 placebo). Discontinuation of treatment due to an adverse event (AE) occurred in 54 patients (33%) who received Adcetris, most commonly due to peripheral sensory and motor neuropathies (14% and 7%, respectively).

Comment: With approximately half of all Hodgkin lymphoma patients who undergo an autologous stem cell transplant experiencing disease relapse, there is a significant need to identify regimens that extend progression-free survival.