EU approves Opdivo (nivolumab) for classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT)- BMS

The European Commission approved Opdivo (nivolumab), from BMS, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union (EU).

The approval is based on an integrated analysis of data from the Phase II CheckMate -205 and the Phase 1 CheckMate -039 trials, evaluating patients with relapsed or refractory cHL after ASCT and treatment with brentuximab vedotin. In the subset of patients in the efficacy population (n=95), the primary endpoint of objective response rate (ORR) as assessed by an independent radiologic review committee was 66% (95% CI: 56-76; 63/95 patients). The percentage of patients with a complete response was 6% (95% CI: 2-13; 6/95 patients), and the percentage of patients with a partial response was 60% (95% CI: 49-70; 57/95 patients). At 12 months, the progression-free survival rate was 57% (95% CI: 45-68).

Opdivo is associated with warnings and precautions including immune-related: pneumonitis, colitis, hepatitis, nephritis and renal dysfunction, endocrinopathies, rash, and other adverse reactions; infusion reactions, and complications of allogeneic hematopoietic stem cell transplantation (HSCT) in cHL after Opdivo.