Professor Owen O’Connnor of Columbia University Medical Center in New York, and colleagues, conducted a multicenter trial of brentuximab vedotin plus bendamustine for treating relapsed or refractory Hodgkin’s Lymphoma. The results were published December 21, 2017 in The Lancet Oncology.
Both brentuximab vedotin and bendamustine have been shown to impart positive outcomes in relapsed or refractory Hodgkin’s Lymphoma. This phase I/II trial was the first to combine both agents in a dose-range study and review toxicity and efficacy outcomes. This study included patients with Hodgkin’s Lymphoma who had progressed, after allogeneic stem cell transplant (ASCT), after declination of ASCT or after receiving at least 2 prior chemotherapy regimens. One patient was included for analysis with a diagnosis of anaplastic large T-cell lymphoma. After the phase I dose range study, all patients in phase II of the trial received brentuximab vedotin 1.8mg/m2 and bendamustine 90mg/m2.
Key findings of the phase II cohort
- N = 37 patients
- Median age = 34 years
- Overall response: 78% (95% CI, 62–91)
- Partial response: 35%
- Stable disease: 14%
- Progression: 8%
- Median duration of response: 3.95 months
- Association of pre-treatment CD30 levels and outcomes
- Significant difference in CD30 levels and complete response (CR) vs stable disease (SD) patients
- Significant difference in CD30 levels and CR vs non-response patients
- No significant change in CD30 levels after treatment in CR, SD, progressive disease, or non-responders
- Grade 3 or 4 adverse events
- Lung infection: 14%
- Neutropenia: 35%
This data represents a potential therapy regimen for relapsed or refractory Hodgkin’s lymphoma patients, as an alternative to toxic platinum-based chemotherapy. In addition to the favorable toxicity profile, there is also the advantage of medications with short infusion times, which may be administered in the ambulatory setting. The phase II data are promising and warrant further study in this population of patients.