European Commission Approves Nivolumab for Relapsed/Refractory Classical Hodgkin Lymphoma

The European Commission approved nivolumab for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) after autologous hematopoietic cell transplantation (HCT) and treatment with brentuximab vedotin.

The approval was based on the results of the phase II CheckMate-205 trial and the phase I CheckMate-039 trial. According to a combined analysis of the two trials, nivolumab resulted in an objective response rate of 66 percent (n=63/95; 95% CI 56-76), with a complete response rate of 6 percent (n=6) and a partial response rate of 60 percent (n=57). The 12-month progression-free survival rate was 57 percent. The median time to response in the combined dataset was two months (range = 0.7-11.1 months), and the median duration of response was 13.1 months (range = 0->23.1 months).

The most common treatment-related adverse events (AEs) included fatigue (32%), upper respiratory tract infection (28%), pyrexia (24%), diarrhea (23%), and cough (22%), and serious AEs occurred in 21 percent of patients. AEs led to treatment discontinuation in 4.2 percent of patients and a dose delay in 23 percent of patients. Six deaths were reported due to complications related to allogeneic HCT following treatment with nivolumab.

Source: Bristol-Myers Squibb news release, November 22, 2016.