Bristol-Myers Squibb Company has reported positive results from cohort B of a Phase II registration trial (CheckMate-205) of Opdivo (nivolumab) in patients with classical Hodgkin lymphoma (cHL).
Opdivo is PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1, which is used by the cancer cells to take refuge from the immune system and block the tumour from being exposed to the immune system.
It prevents the binding of PD-L1 and PD-L2, blocking the PD-1 pathway's suppressive signalling on the immune system including the interference with an anti-tumour immune response.
The Phase II single-arm, open-label, international, multicentre, multi-cohort CheckMate -205 study included patients in cohort B who had a failed response to autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.
During this trial, patients were administered with Opdivo 3mg/kg intravenously every two weeks disease progression or unacceptable toxicity.
The trial focused on the primary endpoint of objective response rate (ORR) per an independent radiologic review committee (IRRC).
The secondary endpoint focuses on the IRRC assessment of objective response duration, complete and partial remission rates andduration of complete and partial remission, and is based on the investigator assessment, objective response and duration of objective response.
The exploratory endpoints include IRRC-assessed progression-free survival (PFS), overall survival (OS), safety and tolerability, and quality of life.
The trial exhibited complete and partial remission and a consistent safety profile of Opdivo throughout the study.
University Hospital of Cologne internal medicine, hematology and oncology professor and lead investigator Andreas Engert 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."
Opdivo is currently undergoing a regulatory trial to treat cHL in the European Union and Japan.