An investigational agent for the treatment of Hodgkin lymphoma has yielded very strong results in a phase II trial of heavily pretreated persons with relapsed or refractory disease. Brentuximab vedotin shrunk tumors in 95% of 102 persons participating in the single-arm, multicenter study designed to evaluate the safety and efficacy of this antibody-drug conjugate.
More than 70% of the study participants, who ranged in age from 15 to 77 years (median: 31 years), had primary refractory disease. In the abstract prepared by investigator Robert Chen and colleagues for the annual meeting of the American Society of Hematology, held December 4-7, 2010 (http://ash.confex.com/ash/2010/webprogram/Paper30260.html), the researchers defined primary refractory disease as failure to achieve complete remission or experiencing progression within 3 months of completing frontline therapy. All study subjects had previously undergone an autologous stem cell transplant (ASCT) and anywhere from 1 to 13 prior regimens of chemotherapy (median: four regimens). More than a third (39%) had lymphoma that was refractory to the most recent salvage therapy excluding ASCT.
In the current intervention, patients received up to 16 cycles (median: nine cycles) of brentuximab vedotin 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion. The treatment was associated with manageable adverse effects, most commonly peripheral sensory neuropathy, fatigue, nausea, neutropenia, diarrhea, and pyrexia.