Study Affirms Activity of Nivolumab in Heavily Pretreated Classical Hodgkin Lymphoma

Treatment with nivolumab (Opdivo) resulted in an encouraging response rate in an expanded population of patients with classical Hodgkin lymphoma who had received brentuximab vedotin and/or after autologous hematopoietic stem cell transplantation (HSCT), according to an announcement by Bristol-Myers Squibb, the developer of nivolumab.¹

For the multi-cohort, single-arm, open-label, phase 2 CheckMate-205 trial (ClinicalTrials.gov Identifier: NCT02181738), investigators enrolled 100 patients with classical Hodgkin lymphoma who had received brentuximab vedotin and autologous HSCT into cohort C to receive nivolumab monotherapy.

After a median follow-up of 8.8 months, results showed that the objective response rate per an independent radiologic review committee (IRRC) was 73% (95% CI, 63-81.4) overall. Response rate was consistent across patient subgroups regardless of whether brentuximab vedotin was administered before or after autologous HSCT.

Among patients who received brentuximab vedotin only before autologous HSCT, the objective response rate was 70% (95% CI, 51.3-84.4); this figure was 88% (95% CI, 47.3-99.7) for patients who had received brentuximab vedotin before and after transplantation.

“These data from cohort C build on existing evidence supporting the benefit of Opdivo in classical Hodgkin lymphoma patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin,” Andreas Engert, MD, study investigator and professor of internal medicine, hematology and oncology, University Hospital of Cologne, in Germany, said in a press release. “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.”

The safety profile of nivolumab in this population was consistent with previous reports. No new meaningful safety signals were detected.

In addition to being indicated for melanoma, lung cancer, and kidney cancer, nivolumab was granted accelerated approval in May 2016 for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous HSCT and post-transplantation brentuximab vedotin. Approval was based on findings from cohort B of CheckMate-205 and the phase 1 CheckMate-039 study. 

Reference

1. New results presented for Opdivo (nivolumab) demonstrate encouraging response rate in an expanded population of heavily pre-treated classical Hodgkin lymphoma patients. Bristol-Myers Squibb website. http://news.bms.com/press-release/bristolmyers/new-results-presented-opdivo-nivolumab-demonstrate-encouraging-response-r. Updated October 25, 2016. Accessed October 25, 2016.