New results presented for Opdivo (nivolumab)

Results demonstrate encouraging response rate in an expanded population of heavily pre-treated classical Hodgkin lymphoma patients.

These data were presented at the 10th International Symposium on Hodgkin Lymphoma (ISHL) in Cologne, Germany on 25 October (Abstract #0149). This abstract was awarded the Karl Musshoff Prize for the Best Clinical Research Abstract, which is granted every 3 years in conjunction with ISHL for outstanding results in the field of Hodgkin lymphoma.

“These data from cohort C build on existing evidence supporting the benefit of Opdivo in cHL patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin,” said Andreas Engert, study investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany. “Results from cohort C indicated a benefit with Opdivo regardless of the order of prior treatment with autologous hematopoietic stem cell transplantation and brentuximab vedotin, providing important insights as we continue researching the potential role Opdivo could provide for heavily pre-treated classical Hodgkin lymphoma patients.”

In May 2016, the FDA approved Opdivo for the treatment of patients with cHL who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin based on a combined analysis of data from cohort B of CheckMate -205 and the Phase I CheckMate -039 trial. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In October 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of Opdivo for the treatment of adult patients with relapsed or refractory cHL after auto-HSCT and treatment with brentuximab vedotin based on data from cohort B of CheckMate -205 and CheckMate -039. The CHMP recommendation is now being reviewed by the European Commission, which has the authority to approve medicines for the European Union. Opdivo also is currently under regulatory review for cHL in Japan.

Fouad Namouni, head of development, Oncology, BMS, commented: “We continue to expand our Immuno-Oncology science in hematology, and these latest results from CheckMate -205 will help inform our research into classical Hodgkin lymphoma and aid us in determining whether Opdivo may provide benefit to a broader population of patients living with this difficult-to-treat disease.”