The use of the antibody-drug conjugate brentuximab vedotin in patients
with relapsed or refractory Hodgkins lymphoma resulted in a high rate of
objective response with a manageable toxicity profile, according to the results
of a phase 2 study.
Based on these data, a placebo-controlled, randomized, phase 3
trial is evaluating the effect of brentuximab vedotin on PFS and OS in
high-risk patients with Hodgkins lymphoma in the post-autologous-stem
cell transplantation setting, the researchers wrote.
The multinational, open-label study included 102 patients with relapsed
or refractory CD30+ Hodgkins lymphoma who had undergone high-dose
chemotherapy and autologous stem cell transplantation. Currently, this patient
population has a very poor prognosis and has no standard-of-care treatment.
Patients were treated with brentuximab vedotin 1.8 mg/kg every 3 weeks.
Patients received a maximum of 16 cycles of the drug in the absence of disease
progression or toxicity.
The objective response rate was 75%, with 34% of patients experiencing
complete remission. Those patients with complete remission had a median
duration of response of 20.5 months. The median PFS for patients was 5.6
The toxicity profile was considered manageable. The most common
treatment-related toxicities were peripheral sensory neuropathy, nausea,
fatigue, neutropenia and diarrhea.
- Younes A. J Clin Oncol.