Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma

In this phase 1/2 study, brentuximab vedotin (BV) and nivolumab (Nivo) administered in combination were evaluated as initial salvage therapy in patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL) (ClinicalTrials.gov #NCT02572167). Patients received up to 4 cycles of combination treatment, with BV administered on Day 1 and Nivo on Day 8 of the first cycle. For Cycles 2-4, BV and Nivo were both administered on Day 1. Following study treatment, responses were evaluated by investigators per the 2014 Lugano classification, and patients could proceed to autologous stem cell transplantation (ASCT). Sixty-two patients were enrolled; the CR rate among all treated patients (n=61) was 61%, with an overall response rate (ORR) of 82%. Prior to ASCT, adverse events (AEs) occurred in 98% of patients, mostly Grades 1 and 2. Infusion related reactions (IRRs) occurred in 44% of patients overall, with 41% of patients experiencing an IRR during at least one infusion of BV. Five patients (8%) were treated with systemic steroids for immune-related AEs. A reduction of T cell subsets including regulatory T cells was observed after the first dose of BV, and reduced serum TARC levels concurrent with an increase in pro-inflammatory cytokines and chemokines were seen after the first BV and Nivo infusions. The combination of BV and Nivo was an active and well-tolerated first salvage regimen, potentially providing patients with R/R HL an alternative to traditional chemotherapy.