Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkins lymphoma
Journal of Clinical Oncology, 05/29/2012
Younes A et al. – The ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy.Methods
- In this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT).
- Patients had histologically documented CD30-positive HL by central pathology review.
- A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles.
- The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility.
- The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months.
- After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease.
- The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea.