EHA 2016
Nivolumab restores effective anti-tumour response in Hodgkin lymphoma
Dr Anas Younes - Memorial Sloan Kettering Cancer Centre, New York, USA
Classical Hodgkin lymphoma, as you know, it’s a disease of young individuals, an average age in the upper twenties, early thirties. There are no treatment options exist for patients who relapse after autologous stem cell transplantation with the exception of brentuximab vedotin which remains the only drug approved by the regulatory agencies, both the FDA and the EMA and other regulatory agencies. Nivolumab was recently approved on May 17th in the United States for the treatment of patients with relapsed Hodgkin lymphoma who failed both autologous transplant and brentuximab vedotin. Nivolumab is now the only second drug approved for this indication for relapsed Hodgkin lymphoma.
The trial is a phase II multi-arm but the focus of this presentation, which is the arm that led to the approval of nivolumab in Hodgkin lymphoma, is called cohort B which is really simple. You take patients who have failed both autologous transplant and brentuximab vedotin at any time – it could be the first qualifying treatment post-autologous transplant, they could have other treatments before or after but they must have had brentuximab vedotin after failing autologous transplant. Then the patient gets enrolled on the nivolumab, receiving 3mg/kg every two weeks until disease progression or prohibitive toxicity and there is scheduled analysis by imaging studies, both by CT and PET scan, and also through an independent review panel.
This is the data. If you look at the overall response rate using independent review panel it’s 66%, it’s 53 out of 80 patients, and by investigator assessment is 73%. If you look at the breakdown of these responses, 9% complete responses and 58% partial responses. But if you look at the waterfall plot it’s more impressive because almost everyone had some benefit, some reduction in tumour measurements, even though some of them did not achieve a partial remission. But the majority of patients had a level of tumour reduction.
The study is still ongoing, the majority of patients are still on treatment so it’s too early to call what is the exact progression free survival. But at the time of the data cut-off a median progression free survival was 7.8 months and the responses were very quick, you can see most responses occur within 2.1 months which is usually at the first assessment.
So the key points are shown here. PD1 is a checkpoint inhibitor, nivolumab is an important new treatment to address unmet need in patients with classical Hodgkin lymphoma with progressive disease and limited treatment options, especially after autologous transplant. Patients who received nivolumab had a very good response, 66% by an independent panel, and reasonable durable responses but this is still ongoing. This may become even longer with time as we follow these patients for a longer period of time. Median duration of response 7.8 months and most patients had a response that was ongoing at the time of the analysis. The safety profile is nothing different from what’s been seen in other solid tumours. Reasonably well tolerated, very rare grade 3 or 4 drug related toxicities and most adverse events were reversible. There was no death related to the treatment on this study.
