New Phase III analysis of Adcetris (brentuximab vedotin) in Hodgkin Lymphoma -Seattle Genetics

Data have been reported from an additional analysis of the Phase III AETHERA clinical trial of Adcetris (brentuximab vedotin), from Seattle Genetics, evaluating PFS by investigator in Hodgkin Lymphoma patients who were refractory to frontline treatment. Previously published data suggest primary-refractory HL patients have poor outcomes following ASCT, as demonstrated by the historical two-year PFS and three-year overall survival rates of less than 40 percent and 50 percent, respectively. Of the 329 patients enrolled in the AETHERA trial, 60 percent (196 patients) were primary-refractory to frontline treatment.

Results of the analysis demonstrated two-year PFS rates among primary-refractory patients on the Adcetris and placebo arms were 60 percent and 42 percent, respectively, consistent with the primary analysis in the full intent-to-treat population. Subgroup analyses of patients by disease characteristics as well as number of risk factors showed that PFS was improved broadly across subgroups, including patients with B-symptoms, extranodal involvement and those who received more than two systemic anticancer treatments pre-ASCT.

Finally, adverse events in primary-refractory patients who received Adcetris were consistent with the known safety profile. Results were presented at the 13th International Conference on Malignant Lymphoma.

Comment: Dr. Robert Chen, Assistant Professor, Hematology & Hematopoietic Cell Transplantation at City of Hope, said: "Up to thirty percent of all patients diagnosed with Hodgkin lymphoma will relapse. These patients have limited treatment options beyond autologous stem cell transplantation and represent a significant unmet medical need. Based on these data, brentuximab vedotin has the potential to change the treatment paradigm for relapsed or refractory Hodgkin lymphoma patients, and could be the first treatment approved for these patients in more than 20 years."