Bristol-Myers Squibb recently presented data supporting the use of Opdivo (nivolumab) in a subgroup of patients with classical Hodgkin’s lymphoma who had undergone a prior stem cell transplant and treatment with Adcetris (brentuximab vedotin).
Results were presented at the 10th International Symposium on Hodgkin’s Lymphoma (ISHL) this week in Cologne, Germany. Also during the event, the study’s research abstract was awarded the Karl Musshoff Prize for the Best Clinical Research Abstract. The award is granted every three years.
The CheckMate -205 (NCT02181738) study is a Phase 2 trial that included four groups of patients with classical Hodgkin’s lymphoma — one group of newly diagnosed patients and three groups of previously treated patients.
The data focuses on a group of 100 patients (cohort C) who had received Adcetris before or after autologous hematopoietic stem cell transplants. Patients were followed for a median of 8.8 months.
An independent committee reviewed radiologic data to determine the objective response rate of Opdivo treatment. The overall objective response rate was 73%, with 17% of patients reaching a complete response. The average progression-free survival time was 11.2 months.
Researchers noted that the response rate did not differ in patients who received Adcetris only before (70%) or only after (72%) the stem cell transplant. In patients treated with Adcetris both before and after stem cell transplant, Opdivo treatment resulted in a response rate of 88%. The trial did not identify any new safety issues.
“These data from cohort C build on existing evidence supporting the benefit of Opdivo in classical Hodgkin’s 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 at the University Hospital Cologne, said in a press release.
The data supported the early approval of Opdivo by the U.S. Food and Drug Administration (FDA) in May 2016 for use in Hodgkin’s lymphoma patients who relapsed or progressed after a stem cell transplant and Adcetris treatment. At the time, the FDA approved the drug based on results from cohort B of CheckMate -205 and the Phase 1 CheckMate -039 trial.
The approval was made under the FDA’s Accelerated Approval Program. Verification of results from earlier trials must be done by Bristol-Myers Squibb for the approval to stay valid.
In October 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also recommended that Opdivo be approved for this patient group.