Research in context
Evidence before this study
To establish the role of brentuximab vedotin in treatment of classical Hodgkin's lymphoma, we searched PubMed on March 18, 2016, for all clinical trials with the terms “Hodgkin lymphoma” AND “brentuximab vedotin”. We did not apply any language restrictions. Among the 16 articles we identified, brentuximab vedotin generally had clinically meaningful efficacy and acceptable tolerability in Hodgkin's lymphoma after autologous stem-cell transplantation (ASCT). Brentuximab vedotin is the only approved treatment for relapsed or refractory Hodgkin's lymphoma following failure of ASCT. In one study, responses upon re-treatment with brentuximab vedotin were reported in patients who progressed after an initial response to brentuximab vedotin; however, no studies investigated new agents for patients who did not respond to brentuximab vedotin treatment.
Added value of this study
In this phase 2 study of nivolumab in a heavily pre-treated population who had not responded to ASCT and brentuximab vedotin, the proportion of patients achieving an objective response was high, and most patients had ongoing responses, including some durable responses that might extend with ongoing follow-up. Nivolumab was well tolerated and had an acceptable safety profile in this patient population. These results validate earlier findings from a phase 1b trial, and will hopefully contribute to research progress in an area with an unmet medical need.
Implications of all the available evidence
Brentuximab vedotin has improved outcomes in patients with classical Hodgkin's lymphoma and is the preferred treatment for patients who have progressed after ASCT. However, many patients eventually become refractory to brentuximab vedotin and have no good therapeutic options. Duration and depth of response are important, because patients are often young and otherwise healthy. Nivolumab provides a new treatment option for patients with classical Hodgkin's lymphoma and has the potential to produce durable responses, even in heavily pre-treated patients.