June 10, 2016

Bristol-Myers Squibb Company has announced results from CheckMate -205, a multi-cohort, single-arm, non-comparative, Phase 2 registrational trial evaluating Opdivo (nivolumab) in classical Hodgkin lymphoma (cHL) patients. The results included patients who had relapsed or progressed after post-transplantation brentuximab vedotin and autologous hematopoietic stem cell transplantation (auto-HSCT). The primary endpoint of objective response rate (ORR) per an independent radiologic review committee (IRRC) was 66.3% (95% CI: 54.8-76.4). Median time to response was 2.1 months, and estimated median duration of remission was 7.8 months (95% CI: 6.6-NE). In an exploratory analysis, it was observed that over two-thirds (72.1%) of patients who did not respond to most recent prior brentuximab vedotin treatment did respond to Opdivo.

Andreas Engert, M.D., lead investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany, said: “There is currently no standard treatment option for classical Hodgkin lymphoma patients who have relapsed or whose disease has progressed after auto-HSCT and post-transplantation brentuximab vedotin. We are encouraged by the objective response rates and that the majority of responses were ongoing at the time of analysis in the CheckMate -205 trial evaluating Opdivo in these heavily pre-treated patients.”

“Classical Hodgkin lymphoma is a disease that disproportionately impacts young people, and there is a significant unmet need for patients who are not cured by the current standard-of-care treatments and who have a poor prognosis and very limited options. The data presented at EHA demonstrate that Opdivo is an important treatment option for patients whose disease has progressed after auto-HSCT and post-transplantation brentuximab vedotin,” said Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb.

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