European Commission approves BMS's Opdivo for Hodgkin's

Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union.

The approval is based on an integrated analysis of data from the Phase II CheckMate -205 and the Phase I 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, 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%. At 12 months, the progression-free survival rate was 57%.

Emmanuel Blin, senior vice president and chief strategy officer, BMS, commented: “We’re incredibly proud of this approval for Opdivo and what it means for adult patients with relapsed or refractory cHL after ASCT and treatment with brentuximab vedotin, as it marks the first and only PD-1 inhibitor approved for a hematologic malignancy in the EU. This also is BMS’s second immuno-oncology agent approved for a blood cancer in the EU within just 6 months.”

“As a practicing hematologist, I have experienced the challenge of managing classical Hodgkin lymphoma and the need among previously treated patients,” said Andreas Engert, lead investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany. “It is incredibly exciting that with today’s approval ... we now have an entirely new treatment approach that has shown impressive response rates and durability of response in this difficult-to-treat population.”