Brentuximab vedotin plus bendamustine may be an effective and safe salvage therapy among patients with relapsed/refractory Hodgkin lymphoma (RR HL) compared with platinum-based chemotherapy prior to autologous stem cell transplant (ASCT), according to a study published in The Lancet Oncology.1
Previous studies demonstrated that brentuximab vedotin and bendamustine monotherapies improve the overall response rate (ORR) of patients with RR HL, though no meaningful progression-free survival (PFS) improvement was noted.
For this 2-part phase 1/2 study (ClinicalTrials.gov Identifier: NCT01657331), investigators enrolled 65 patients (98% of whom had Hodgkin lymphoma; 28 patients during stage 1 and 37 during stage 2) who had failed at least 1 previous chemotherapy regimen. Stage 1 of the study was an exploratory dose-determining study; in stage 2, patients received the recommended dose from stage 1.
A maximum tolerated dose was not reached for phase 1, but dose-limiting neutropenia and diffuse rash were observed in 2 patients and 1 patient, respectively.
Patients who received the recommended phase 1 dose of brentuximab vedotin 1.8 mg/kg plus bendamustine 90 mg/m2 had an overall response of 78% (95% CI, 62%-91%).
The most frequently reported serious adverse events included grade 3 lung infection and grade 3 or 4 neutropenia. No treatment-related deaths were reported.
The authors of the study concluded that brentuximab vedotin plus bendamustine has potential as a treatment in the setting and thereafter. They concluded that “coupled with ASCT, this combination therapy might achieve a substantial improvement in these patients compared with traditional, platinum-based salvage regimens. Further studies, preferably randomized trials that will allow formal cross-regimen efficacy comparisons, are warranted.”
- O’Connor OA, Lue JK, Sawas A, et al. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol. 2017 Dec 21. doi: 10.1016/S147-(17)30912-9 [Epub online ahead of print]