(ChemotherapyAdvisor) – The antibody-drug conjugate brentuximab vedotin induced objective responses in 75% of patients with relapsed or refractory Hodgkin’s lymphoma after autologous stem-cell transplantation, results of a multinational pivotal Phase 2 open-label trial published in the Journal of Clinical Oncology online March 26 has found.
Brentuximab vedotin selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. The investigators evaluated the efficacy and safety of outpatient brentuximab vedotin 1.8mg/kg by intravenous infusion every three weeks in 102 patients who had histologically documented CD30-positive Hodgkin’s lymphoma by central pathology review. A maximum of 16 cycles of therapy was administered in the absence of disease progression or prohibitive toxicity.
Overall objective response rate, the primary end point, was 75%, with 34% of patients experiencing complete remission. Median progression-free survival was 5.6 months; median duration of response for those in complete remission was 20.5 months. A total of 31 patients were alive and free of documented progressive disease after a median observation time of >1.5 years. Peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea were the most common treatment-related adverse events.
“Although patients enrolled onto this study had a poor prognosis and had previously received multiple chemotherapy regimens, almost all achieved tumor regression….” the investigators wrote. “These results provide support for clinical evaluation in patients with earlier stage disease.”
Currently, a Phase 1 trial is evaluating the combination of brentuximab vedotin and multiagent chemotherapy in untreated, newly diagnosed patients with Hodgkin’s lymphoma, and a randomized, placebo-controlled Phase 3 trial is evaluating the effect of brentuximab vedotin on progression-free survival and overall survival in high-risk patients with Hodgkin’s lymphoma following autologous stem-cell transplantation.