The ongoing multicohort CheckMate-205 study evaluated objective response rates, the primary endpoint, as well as duration of response rates for each cohort, all of which were assessed by the Independent Radiology Review Committee. Patients enrolled in this trial were treated with nivolumab 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. There were 243 adult patients with relapsed/refractory classical Hodgkin lymphoma at trial entry, and 77% of patients had stage III or greater disease. At median follow-up between 16 and 23 months, 97 patients remained on treatment.
In the brentuximab vedotin–naive group (Cohort A, n = 63), with a median follow-up of 19 months, patients had an objective response rate of 65%, with a complete response in 29% of patients. The median duration of response was 20 months and the median progression-free survival was 18.3 months (95% confidence interval = 11.1–22.4).
In the group that had BV therapy after ASCT (Cohort B, n = 80), with a median follow-up of 23 months, the objective response rate was 68%, with complete response in 13% of patients. The median duration of response was 16 months, and the median progression-free survival was 14.7 months (95% CI = 10.5–19.6).
In patients who had received brentuximab before (n = 33), after (n = 58), or before and after (n = 9) ASCT (Cohort C, n = 100), with a median follow-up of 16 months, the objective response rate was 73%, with complete response in 12% of patients. The median duration of response was 15 months, and the median progression-free survival was 11.9 months (95% CI = 11.1–18.4).
Across cohorts, the median overall survival was not reached, and 40% of patients remained on treatment.
The safety profile was consistent with previously reported data in this tumor type. The most common treatment-related adverse events were fatigue (23%), diarrhea (15%), and infusion reactions (IRs; 14%). Grade 3 or 4 adverse events experienced included fatigue (1%), diarrhea (1%), and rash (1%).
“Treatment options are limited for patients with classical Hodgkin Lymphoma after ASCT has failed, which is why the high objective response rates shown across cohorts of the CheckMate-205 study are encouraging,” said Michelle Fanale, MD, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center. “The results are particularly welcome news, as patients experienced responses regardless of brentuximab vedotin treatment history or the depth of their Hodgkin lymphoma’s response to brentuximab vedotin.”
“These extended results across cohorts indicate that nivolumab may offer a potential treatment option for patients with classical Hodgkin Lymphoma progressing after ASCT,” said Jonathan Leith, Hematology Development Lead, Bristol-Myers Squibb.