Adcetris brentuximab vedotin: Phase III data
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 met the primary endpoint of improving PFS vs. placebo (HR=0.57, p=0.001). Specifically, Seattle Genetics said Adcetris led to a 75% improvement in PFS. A pre-specified interim analysis of OS, a secondary endpoint, showed no significant difference between treatment arms. On a conference call to discuss the data, the company said OS data are not yet mature. Further OS analysis is planned for 2016. Detailed PFS data were submitted for presentation at the American Society of Hematology meeting in San Francisco in December. In 1H15, Seattle Genetics plans to submit an sBLA to FDA for Adcetris as consolidation therapy in Hodgkin's lymphoma patients immediately following ASCT.
Adcetris has accelerated approval in the U.S. to treat Hodgkin's lymphoma after failure of ASCT or after failure of >=2 prior multi-agent chemotherapy regimens and to treat anaplastic large cell lymphoma (ALCL) after failure of >=1 prior multi-agent chemotherapy regimen. As part of the approval, Seattle Genetics is required to conduct 2 Phase III confirmatory trials, 1 for each indication. AETHERA is not a confirmatory trial but does fulfill a postmarketing safety requirement (see BioCentury, Aug. 22, 2011). ...