Regardless of previous history with brentuximab vedotin, patients with classic relapsed/refractory Hodgkin lymphoma (R/R HL) following autologous stem cell transplantation (ASCT) who received nivolumab experienced high rates of response. Complete response (CR) and partial response (PR) seemed durable on continued follow-up, according to the results from the phase 2 CheckMate 205 trial (ClinicalTrials.gov identifier: NCT02181738) presented at the 14th Annual Conference on Malignant Lymphoma.
Nivolumab (Opdivo®) is a monoclonal antibody that inhibits programmed cell death-1 and is indicated in patients with R/R HL after ASCT and brentuximab vedotin. Patients with R/R HL face a dearth of treatment options following ASCT. The extended follow-up results from CheckMate 205 describe clinical outcomes in all patients with R/R HL after failure of ASCT.
Cohort A included 63 patients who were treatment-naïve for brentuximab vedotin; Cohort B, 80 patients who received brentuximab vedotin after ASCT; and Cohort C, 100 patients who received brentuximab vedotin before (n=33), after (n=58), and before and after (n=9) ASCT.
All patients received 3 mg/kg of nivolumab once every 2 weeks until progression or unacceptable toxicity. Patients in Cohort C who experienced CR for 1 year discontinued nivolumab and could restart nivolumab on relapse.
Patient age ranged from 18 years to 72 years (median: 34 years), and more than three-quarters of patients had stage III or greater disease on entry into the study. Median follow-up was 19 months in Cohort A, 23 months in Cohort B, and 16 months in Cohort C, at which point 40% of patients remained on treatment.
Overall response rate was 65% in brentuximab vedotin-naïve patients (Cohort A), 68% in patients with brentuximab vedotin after ASCT (Cohort B), and 73% in patients with brentuximab vedotin before and/or after ASCT (Cohort C). CR was 29% in Cohort A, 13% in Cohort B, and 12% in Cohort C.
Median duration of response (DOR) was 20 months in brentuximab vedotin-naïve patients. In patients who received brentuximab vedotin, median DOR was 16 months (Cohort B) and 15 months (Cohort C).
In patients with CR, DOR was 20 months in Cohort A and 15 months or longer in Cohorts B and C. Median OS was not reached.
The most frequent treatment-related adverse events (TRAEs) were fatigue (23%), diarrhea (15%), and infusion reactions (14%). The most frequent serious TRAEs were infusion reactions (2%) and pneumonitis (1%).
1. Fanale M, Engert A, Younes A, et al. Nivolumab for relapsed/refractory classical Hodgkin lymphoma after autologous transplant: full results after extended follow-up of the phase 2 CheckMate 205 trial. Oral presentation at: 14th International Conference on Malignant Lymphoma; June 14-17, 2017; Lugano, Switzerland.