Adcetris brentuximab vedotin: Additional Phase III data

Additional data from the double-blind, international Phase III AETHERA trial in 329 Hodgkin’s lymphoma patients with =1 risk factor for progression showed that 1.8 mg/kg IV Adcetris every 3 weeks following ASCT led to a median PFS, the primary endpoint, of 43 months vs. 24 months for placebo (HR=0.57, p=0.001). The 2-year PFS rate in the Adcetris arm was 63% vs. 51% for the placebo arm. An analysis of OS, a secondary endpoint, showed no significant difference between treatment arms (p=0.62), but the partners said OS data are still not yet mature. Further OS analysis is planned for 2016. Data were presented at the American Society of Hematology meeting in San Francisco. Previously reported data from AETHERA showed that Adcetris met the primary endpoint (see BioCentury, Oct. 6). ...