The use of anti–PD-1 therapy is likely to become a key part of future therapeutic approaches in Hodgkin lymphoma and is now being incorporated into earlier lines of therapy in this disease.— Stephen M. Ansell, MD, PhD
It is commonly said that if something is too good to be true, it usually is. It is therefore quite refreshing when really good results are replicated in a subsequent study.
As reported in The Lancet Oncology by Younes et al1 and reviewed in this issue of The ASCO Post, a phase II trial of nivolumab (Opdivo) in relapsed Hodgkin lymphoma patients has yielded results confirming the promising findings seen in a prior phase I trial in this disease. The original phase I trial showed a very high response rate in a small cohort of patients with Hodgkin lymphoma treated with nivolumab who had experienced disease progression after a previous autologous stem cell transplantation and brentuximab vedotin (Adcetris) therapy. In this subsequent phase II trial, a much larger cohort of patients with progression after an autologous stem cell transplantation and therapy with brentuximab vedotin received 3 mg/kg of nivolumab over 60 minutes every 2 weeks until progression.
Eighty patients were treated, and an objective response based on the assessment of an independent review committee was seen in 53 (66.3%) of the patients. The majority of patients had a partial remission, but complete responses were seen in 9%. Patients had a rapid response to therapy, with a median time to response of 2.1 months.
The median duration of response was 7.8 months at the time of the analysis. At the time of the report, 62% of the patients had an ongoing response, and at least 20 patients had a response that was more durable than 4 months.
The therapy was well tolerated, and the most common side effects were similar to those that have been seen in many other studies with immune checkpoint therapy. Notably, most patients could remain on therapy, and only 5% discontinued treatment due to adverse events.
All told, the treatment resulted in frequent responses and an acceptable safety profile. The results of this trial as well as the data from the phase I study have now led to the approval of nivolumab for patients with disease progression after previous autologous stem cell transplantation and brentuximab vedotin therapy.
Overall, these data are highly significant in that they confirm the preliminary data from the phase I trial and have established programmed cell death protein 1 (PD-1) blockade as an appropriate therapy for patients with relapsed and refractory Hodgkin lymphoma. The use of anti–PD-1 therapy is likely to become a key part of future therapeutic approaches in Hodgkin lymphoma and is now being incorporated into earlier lines of therapy in this disease. ν
Disclosure: Dr. Ansell receives institutional research funding from Bristol-Myers Squibb, Merck, and Seattle Genetics.
1. 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. July 20, 2016 (early release online).
Nivolumab might be a new treatment option for a patient population with a high unmet need [patients with classical Hodgkin lymphoma after failure of both ASCT and brentuximab vedotin]. Ongoing follow-up will help to assess the durability of response.!-->!-->— Anas Younes, MD, and ...