It is the company’s second immuno-oncology agent approved for a blood cancer in the EU within just six months. It is also the sixth EU approval for Opdivo in four different cancer types in less than two years.
Data from the phase 2 CheckMate -205 and the phase 1 CheckMate -039 trials served as the basis for the EC approval.
The trials assessed 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%.
The percentage of patients with a complete response was 6%, and the percentage of patients with a partial response was 60%. The progression-free survival rate was 57% at 12 months.
Opdivo is designed to harness the body’s own immune system to help restore anti-tumor immune response.
Its worldwide development program includes a range of clinical trials across all phases, including phase 3, in several tumor types.
More than 25,000 patients have so far been enrolled in the Opdivo clinical development program.
Opdivo is currently approved in over 57 countries, including the US, the EU and Japan.
Image: Bristol-Myers Squibb’s facility in Brussels, Belgium. Photo: courtesy of Bristol-Myers Squibb Company.