Nivolumab induced frequent responses with an acceptable safety profile for patients with classical Hodgkin lymphoma who progressed after both autologous hematopoietic stem cell transplantation (auto-HSCT) and brentuximab vedotin, according to a phase 2 study published in The Lancet Oncology.1
Researchers assessed the clinical benefit and safety of single-agent nivolumab for patients who failed both auto-HSCT and brentuximab vedotin in this single-arm study, in which 80 patients were enrolled. Participants received nivolumab at a dose of 3 mg/kg intravenously over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or death.
Results of the ongoing study showed that 66.3% (95% CI, 54.8-76.4) of the 80 patients achieved an objective response as assessed by an independent radiological review committee, at a median follow-up of 8.9 months.
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The most common immunotherapy-related adverse events were fatigue (25%), infusion-related reaction (20%), and rash (16%). The most frequently reported grade 3 to 4 adverse events were neutropenia (5%) and increased lipase concentrations (5%); the most common serious adverse event was pyrexia (4%).
Although 3 patients died, no deaths were considered related to nivolumab therapy.
- Younes A, Santoro A, Shipp M, et al. Nivolumab for classical Hodgkin’s lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial. Lancet Oncol. 2016 Jul 20. doi: 10.1016/S1470-2045(16)30167-X [Epub ahead of print]