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Extended follow-up of CheckMate 205: frequent and durable responses in patients with r/r classical Hodgkin lymphoma treated with nivolumab

During the EHA 2017 the extended follow-up data of CheckMate 205 for all patients with relapsed/refractory (r/r) classical Hodgkin lymphoma (cHL) after failure of ASCT treated with nivolumab were presented. Previously, Younes and colleagues reported the initial analyses of this study, revealing high objective response rates (ORR), encouraging duration of response (DOR) and an acceptable safety profile.1

Patients with r/r cHL have a high frequency of 9p24.1 genetic alterations and overexpression of PD-L1 and PD-L2. Since nivolumab is a fully immunoglobulin antibody blocking signaling through the PD-1 receptor, this could be a unique treatment option for these patients.

This single-arm multicenter CheckMate 205 trial enrolled 243 patients with r/r cHL after ASCT into 1 of 3 independent cohorts: (1) cohort A: brentuximab vedotin (BV)-naïve (n=63), (2) cohort B: BV only after ASCT (n=80), and (3) cohort C: BV before and/or after ASCT (n=100).2 All patients were treated with nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity. In addition, patients in cohort C with a persistent complete response (CR) for 1 year discontinued nivolumab and could resume at relapse. The primary endpoint was ORR per Independent Radiology Review Committee I(RC). Secondary endpoints included CR/PR rates, duration of CR/PR, progression-free survival (PFS) by IRC, overall survival (OS), and safety. The follow-up of the current analysis was 19, 23 and 16 months for patients in cohorts A, B, and C, respectively.

Overall, 40% of patients were still on treatment; the most common reason for discontinuation was disease progression (26%). The overall ORR per IRC was 69% (65% in cohort A, 68% in cohort B, and 73% in cohort C), with 29%, 13%, and 12% CR, respectively. Patients with CR have a longer median treatment duration compared to patients with PR (median 20 months versus 13 months, respectively). Moreover, a prolonged median PFS was seen for patients with CR (median 22 months), PR (median 15 months) and stable disease (median 11 months) and the median OS was not reached in any cohort.

The most common drug-related adverse events (any grade) were fatigue (23%), diarrhea (15%), infusion reactions (14%), and rash (12%).The most common drug-related serious adverse events were infusion reactions (2%) and pneumonitis (1%).

In summary, this extended follow-up of nivolumab in r/r cHL patients demonstrate that these patients have frequent and durable responses irrespective of BV treatment history with a CR rate of 29% for BV-naïve patients. In addition, a sustained PFS was reported for patients who achieved CR, PR or stable disease. Lastly, the safety profile is acceptable and consistent with previous reports. These results led to the conclusion that nivolumab may offer a favorable long-term treatment option for a broad spectrum of patients with r/r cHL progressing after ASCT. Durable responses to therapy are valuable in these patients since their treatment options are limited.


1 Engert A, Santora A, Shipp M, et al. CheckMate 205: a phase 2 study of nivolumab in patients with classical Hodgkin lymphoma following autologous stem cell transplantation and brentuximab vedotin. EHA 2016, oral presentation, abstract S793

2 Engert A, Fanale M, Santoro A, et al. Nivolumab for relapsed/refractory classical Hodgkin lymphoma after autologous transplant: full results after extended follow-up of the multicohort multicenter phase 2 CheckMate 205 trial. EHA 2017, oral presentation, abstract S412


Speaker Andreas Engert


Prof. Andreas Engert, MD, Uniklinik Köln, Germany


See: Keyslides


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