Despite significant improvements in the treatment of patients with advanced-stage, newly diagnosed Hodgkin lymphoma (HL) with combined chemotherapy and radiotherapy that have led to durable remission rates of approximately 60% to 80%, a large proportion of patients are not cured and new therapies are needed. Patients with relapsed and/or refractory HL have poor prognosis. Newly reported results of a phase 2 clinical trial have shown that treatment with the antibody-drug conjugate brentuximab vedotin achieves high response rates in patients with relapsed or refractory HL whose disease has progressed even after receiving autologous stem-cell transplant (auto-SCT) salvage therapy (Younes A, et al. J Clin Oncol. 2012;30:2183-2189).
This multinational, open-label study included 102 patients (median age, 31 years) with relapsed (71%) and/or refractory (42%) HL after chemotherapy and auto-SCT. All patients received brentuximab vedotin 1.8 mg/kg intravenously every 3 weeks. Those who did not progress or did not have prohibitive adverse events continued with this therapy for a maximum of 16 cycles.
Overall response rate (ORR) was the primary end point.
Tumor reductions were seen in 94% of patients, and the ORR was 75% (95% confidence interval [CI], 64.9%-82.6%). Of all patients, 34% achieved a complete response (CR) and 96% met the classification of overall disease control (CR plus partial remission plus stable disease).
The estimated 12-month survival was 89% (95% CI, 83%-95%). At a median period of 1.5 years (range, 1.8-23.5 months), 31 of the 102 patients were alive and free of disease progression, and 28 patients died.
Adverse events were manageable with standard supportive care, and most were grade 1 or 2. A total of 56 patients had a grade ≥3 event after prolonged use of the drug; most of these events were neutropenia (20%), thrombocytopenia (8%), and anemia (6%).
These results have prompted further investigation of brentuximab vedotin for earlier-stage disease and in combination with other therapies. A phase 1 trial is investigating this drug with multiagent chemotherapy in treatment-naïve patients with HL, and a phase 3 clinical trial is evaluating the impact of brentuximab vedotin on progression-free survival and overall survival in high-risk patients with HL after auto-SCT.
