Europe's Committee for Medicinal Products for Human Use recommended nivolumab for the treatment of patients with relapsed/refractory classic Hodgkin lymphoma (cHL) after autologous hematopoietic cell transplantation (AHCT) and treatment with brentuximab vedotin.
The recommendation was based on the results of the phase I CheckMate-039 trial and phase II CheckMate-205 trial.
In the phase I study that included 23 patients, the overall response rate was 87 percent (n=20), including six complete remissions (CRs) and 14 partial remissions (PRs) after a median follow-up of 86 weeks (range = 32-107 weeks). In addition, 50 percent of patients had durable responses.
The time to CR ranged from three to 88 weeks following initiation of nivolumab therapy, including two patients whose PRs converted to a CR. Of the 20 responses, 75 percent (n=15) occurred within 16 weeks of starting treatment. Three patients achieved stable disease.
In the phase II study that included 80 patients, nivolumab induced responses in 66 percent of patients, including seven CRs and 46 PRs. In addition, six-month progression-free was 76.9 percent (95% CI 64.9-85.3), while overall survival was 99 percent (95% CI 91-100). The median progression-free survival was 10 months (95% CI 8.4-not available).
The most common adverse events reported by patients in both trials were fatigue (32.3%), diarrhea (28.9%), pyrexia (27.1%), and cough (25.9%).
Source: Bristol-Myers Squibb press release, October 14, 2016.